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Vaccine ‘Will Not Curb’ Dengue Epidemic, Says PAHO

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Thu, 04/18/2024 - 14:58

 

The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.

The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. 

“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.

“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.

The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.

A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.

PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”

“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.

The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.

“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.

Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.

In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.

Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com .

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The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.

The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. 

“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.

“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.

The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.

A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.

PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”

“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.

The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.

“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.

Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.

In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.

Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com .

 

The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.

The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. 

“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.

“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.

The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.

A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.

PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”

“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.

The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.

“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.

Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.

In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.

Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com .

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LOEWY</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan America</metaDescription> <articlePDF/> <teaserImage/> <teaser>The most important actions to take in addition to vaccination are field operations, vector control, prevention, and education.</teaser> <title>Vaccine ‘Will Not Curb’ Dengue Epidemic, Says PAHO</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">20</term> <term>21</term> <term>25</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>234</term> <term>311</term> <term>316</term> <term canonical="true">317</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Vaccine ‘Will Not Curb’ Dengue Epidemic, Says PAHO</title> <deck/> </itemMeta> <itemContent> <p>The current tetravalent <span class="Hyperlink"><a href="https://reference.medscape.com/drug/dengvaxia-dengue-vaccine-1000308">dengue vaccine</a></span> TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.</p> <p>The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. <br/><br/>“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a <span class="Hyperlink"><a href="https://www.youtube.com/watch?v=Ivlu_L1YfrQ">press conference</a></span> on March 28.<br/><br/>“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.<br/><br/>The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.<br/><br/>A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.<br/><br/>PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”<br/><br/>“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.<br/><br/>The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.<br/><br/>“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.<br/><br/>Other research strategies for vector control, such as the use of the <span class="Emphasis">Wolbachia</span> bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.<br/><br/>In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.<br/><br/>Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, <span class="Hyperlink"><a href="https://www.paho.org/es/noticias/28-3-2024-ops-llama-accion-colectiva-ante-aumento-record-casos-dengue-americas">PAHO reported</a></span>.<span class="end"/></p> <p> <em> <span class="Emphasis">This story was translated from the <a href="https://espanol.medscape.com/verarticulo/5912228">Medscape Spanish edition</a> using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on </span> <span class="Hyperlink"> <a href="https://www.medscape.com/viewarticle/vaccine-will-not-curb-dengue-epidemic-says-paho-2024a1000705?src=">Medscape.com</a> </span> <span class="Emphasis">.</span> </em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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European Scientists Assess Avian Flu Pandemic Risk

Article Type
Changed
Fri, 04/12/2024 - 13:15

As avian influenza continues to spread among wild bird populations in the European Union (EU), scientists have described a wide range of factors that could drive the virus to spread efficiently among humans, thereby increasing its pandemic potential.

Although transmission of avian influenza A(H5N1) from infected birds to humans is rare, “new strains carrying potential mutations for mammalian adaptation” could occur, according to a report issued on April 3 by the European Centre for Disease Prevention and Control and the European Food Safety Authority. The analysis identified a threat of strains currently circulating outside Europe that could enter the EU and the wider European Economic Area (EEA).

“If avian A(H5N1) influenza viruses acquire the ability to spread efficiently among humans, large-scale transmission could occur due to the lack of immune defenses against H5 viruses in humans,” the report warned.
 

Evolution of Avian Influenza Remains Hard to Predict

However, despite many occurrences of human exposure to avian influenza since 2020, “no symptomatic or productive infection in a human has been identified in the EU/EEA,” the scientists stated. Furthermore, after almost three decades of human exposure to the A(H5N1) virus of the Gs/GD lineage, the virus has not yet acquired the mutations required for airborne transmissibility between humans. However, it remains “difficult to predict the evolutionary direction the virus will take in the future,” the scientists assessed.

“Clearly, humans are being exposed in the current USA cattle outbreak,” Professor James Wood, infectious disease epidemiologist at the University of Cambridge, United Kingdom, told this news organization. “But, arguably, what is more significant is how few cases there have been with this virus lineage and its close relatives, despite massive global exposures over the last 3 years. All diagnosed human cases seem to have been singletons, with no evidence of human-to-human transmission.”

Ian Jones, professor of virology at the University of Reading, United Kingdom, sees no evidence of an imminent spillover of avian influenza from birds. But he told this news organization: “The trouble is, the clock resets every minute. Every time the virus has come out of a bird and gone somewhere, the clock is reset. So you can never say that just because it hasn’t happened since whenever, it’s never going to happen.”

 

Preventive Measures Recommended

The European report recommended a range of cautionary measures that included enhanced surveillance, access to rapid diagnostics, and sharing of genetic sequence data. It urged EU authorities to work together, adopting a One Health perspective, to limit the exposure of mammals, including humans, to avian influenza viruses. 

Sarah Pitt, a microbiologist at the University of Brighton, United Kingdom, said the emphasis on authorities taking a One Health approach was sound. “You’re looking at humans, animals, plants, and the environment and how they’re all closely interacted,” she told this news organization. “Putting all those things together is actually going to be good for human health. So they’ve mentioned One Health a lot and I’m sure that’s on purpose because it’s the latest buzzword, and presumably it’s a way of getting governments to take it seriously.” 

Overall, Dr. Pitt believes the document is designed to move zoonotic infectious diseases a bit higher up the agenda. “They should have been higher up the agenda before COVID,” she said.

The report also called for consideration of preventative measures, such as vaccination of poultry flocks. 

Overall, Dr. Jones assesses the European report as “a reworking of what’s been pretty well covered over the years.” Despite extensive work by scientists in the field, he said: “I’m not sure we’re any better at predicting an emerging virus than we’ve ever been. I would point out that we didn’t spot SARS-CoV-2 coming, even though we had SARS-CoV-1 a few years earlier. Nobody spotted the 2009 pandemic from influenza, even though there was a lot of surveillance around at the time.”
 

A version of this article appeared on Medscape.com.

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As avian influenza continues to spread among wild bird populations in the European Union (EU), scientists have described a wide range of factors that could drive the virus to spread efficiently among humans, thereby increasing its pandemic potential.

Although transmission of avian influenza A(H5N1) from infected birds to humans is rare, “new strains carrying potential mutations for mammalian adaptation” could occur, according to a report issued on April 3 by the European Centre for Disease Prevention and Control and the European Food Safety Authority. The analysis identified a threat of strains currently circulating outside Europe that could enter the EU and the wider European Economic Area (EEA).

“If avian A(H5N1) influenza viruses acquire the ability to spread efficiently among humans, large-scale transmission could occur due to the lack of immune defenses against H5 viruses in humans,” the report warned.
 

Evolution of Avian Influenza Remains Hard to Predict

However, despite many occurrences of human exposure to avian influenza since 2020, “no symptomatic or productive infection in a human has been identified in the EU/EEA,” the scientists stated. Furthermore, after almost three decades of human exposure to the A(H5N1) virus of the Gs/GD lineage, the virus has not yet acquired the mutations required for airborne transmissibility between humans. However, it remains “difficult to predict the evolutionary direction the virus will take in the future,” the scientists assessed.

“Clearly, humans are being exposed in the current USA cattle outbreak,” Professor James Wood, infectious disease epidemiologist at the University of Cambridge, United Kingdom, told this news organization. “But, arguably, what is more significant is how few cases there have been with this virus lineage and its close relatives, despite massive global exposures over the last 3 years. All diagnosed human cases seem to have been singletons, with no evidence of human-to-human transmission.”

Ian Jones, professor of virology at the University of Reading, United Kingdom, sees no evidence of an imminent spillover of avian influenza from birds. But he told this news organization: “The trouble is, the clock resets every minute. Every time the virus has come out of a bird and gone somewhere, the clock is reset. So you can never say that just because it hasn’t happened since whenever, it’s never going to happen.”

 

Preventive Measures Recommended

The European report recommended a range of cautionary measures that included enhanced surveillance, access to rapid diagnostics, and sharing of genetic sequence data. It urged EU authorities to work together, adopting a One Health perspective, to limit the exposure of mammals, including humans, to avian influenza viruses. 

Sarah Pitt, a microbiologist at the University of Brighton, United Kingdom, said the emphasis on authorities taking a One Health approach was sound. “You’re looking at humans, animals, plants, and the environment and how they’re all closely interacted,” she told this news organization. “Putting all those things together is actually going to be good for human health. So they’ve mentioned One Health a lot and I’m sure that’s on purpose because it’s the latest buzzword, and presumably it’s a way of getting governments to take it seriously.” 

Overall, Dr. Pitt believes the document is designed to move zoonotic infectious diseases a bit higher up the agenda. “They should have been higher up the agenda before COVID,” she said.

The report also called for consideration of preventative measures, such as vaccination of poultry flocks. 

Overall, Dr. Jones assesses the European report as “a reworking of what’s been pretty well covered over the years.” Despite extensive work by scientists in the field, he said: “I’m not sure we’re any better at predicting an emerging virus than we’ve ever been. I would point out that we didn’t spot SARS-CoV-2 coming, even though we had SARS-CoV-1 a few years earlier. Nobody spotted the 2009 pandemic from influenza, even though there was a lot of surveillance around at the time.”
 

A version of this article appeared on Medscape.com.

As avian influenza continues to spread among wild bird populations in the European Union (EU), scientists have described a wide range of factors that could drive the virus to spread efficiently among humans, thereby increasing its pandemic potential.

Although transmission of avian influenza A(H5N1) from infected birds to humans is rare, “new strains carrying potential mutations for mammalian adaptation” could occur, according to a report issued on April 3 by the European Centre for Disease Prevention and Control and the European Food Safety Authority. The analysis identified a threat of strains currently circulating outside Europe that could enter the EU and the wider European Economic Area (EEA).

“If avian A(H5N1) influenza viruses acquire the ability to spread efficiently among humans, large-scale transmission could occur due to the lack of immune defenses against H5 viruses in humans,” the report warned.
 

Evolution of Avian Influenza Remains Hard to Predict

However, despite many occurrences of human exposure to avian influenza since 2020, “no symptomatic or productive infection in a human has been identified in the EU/EEA,” the scientists stated. Furthermore, after almost three decades of human exposure to the A(H5N1) virus of the Gs/GD lineage, the virus has not yet acquired the mutations required for airborne transmissibility between humans. However, it remains “difficult to predict the evolutionary direction the virus will take in the future,” the scientists assessed.

“Clearly, humans are being exposed in the current USA cattle outbreak,” Professor James Wood, infectious disease epidemiologist at the University of Cambridge, United Kingdom, told this news organization. “But, arguably, what is more significant is how few cases there have been with this virus lineage and its close relatives, despite massive global exposures over the last 3 years. All diagnosed human cases seem to have been singletons, with no evidence of human-to-human transmission.”

Ian Jones, professor of virology at the University of Reading, United Kingdom, sees no evidence of an imminent spillover of avian influenza from birds. But he told this news organization: “The trouble is, the clock resets every minute. Every time the virus has come out of a bird and gone somewhere, the clock is reset. So you can never say that just because it hasn’t happened since whenever, it’s never going to happen.”

 

Preventive Measures Recommended

The European report recommended a range of cautionary measures that included enhanced surveillance, access to rapid diagnostics, and sharing of genetic sequence data. It urged EU authorities to work together, adopting a One Health perspective, to limit the exposure of mammals, including humans, to avian influenza viruses. 

Sarah Pitt, a microbiologist at the University of Brighton, United Kingdom, said the emphasis on authorities taking a One Health approach was sound. “You’re looking at humans, animals, plants, and the environment and how they’re all closely interacted,” she told this news organization. “Putting all those things together is actually going to be good for human health. So they’ve mentioned One Health a lot and I’m sure that’s on purpose because it’s the latest buzzword, and presumably it’s a way of getting governments to take it seriously.” 

Overall, Dr. Pitt believes the document is designed to move zoonotic infectious diseases a bit higher up the agenda. “They should have been higher up the agenda before COVID,” she said.

The report also called for consideration of preventative measures, such as vaccination of poultry flocks. 

Overall, Dr. Jones assesses the European report as “a reworking of what’s been pretty well covered over the years.” Despite extensive work by scientists in the field, he said: “I’m not sure we’re any better at predicting an emerging virus than we’ve ever been. I would point out that we didn’t spot SARS-CoV-2 coming, even though we had SARS-CoV-1 a few years earlier. Nobody spotted the 2009 pandemic from influenza, even though there was a lot of surveillance around at the time.”
 

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167655</fileName> <TBEID>0C04F839.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F839</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240412T122929</QCDate> <firstPublished>20240412T130420</firstPublished> <LastPublished>20240412T130421</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240412T130420</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Peter Russell</byline> <bylineText>PETER RUSSELL</bylineText> <bylineFull>PETER RUSSELL</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>As avian influenza continues to spread among wild bird populations in the European Union (EU), scientists have described a wide range of factors that could driv</metaDescription> <articlePDF/> <teaserImage/> <teaser>The analysis identified a threat of strains with mammalian adaptation currently circulating outside Europe that could enter the EU and the wider European Economic Area.</teaser> <title>European Scientists Assess Avian Flu Pandemic Risk</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">20</term> <term>21</term> <term>6</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>320</term> <term canonical="true">317</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>European Scientists Assess Avian Flu Pandemic Risk</title> <deck/> </itemMeta> <itemContent> <p><br/><br/>As <span class="Hyperlink">avian influenza</span> continues to spread among wild bird populations in the European Union (EU), scientists have described a wide range of factors that could drive the virus to spread efficiently among humans, thereby increasing its pandemic potential.<br/><br/>Although transmission of avian influenza A(H5N1) from infected birds to humans is rare, “new strains carrying potential mutations for mammalian adaptation” could occur, according to a <span class="Hyperlink"><a href="https://www.ecdc.europa.eu/en/publications-data/drivers-pandemic-due-avian-influenza-and-options-one-health-mitigation-measures">report issued on April 3 by the European Centre for Disease Prevention and Control</a></span> and the European Food Safety Authority. The analysis identified a threat of strains currently circulating outside Europe that could enter the EU and the wider European Economic Area (EEA).<br/><br/>“If avian A(H5N1) influenza viruses acquire the ability to spread efficiently among humans, large-scale transmission could occur due to the lack of immune defenses against H5 viruses in humans,” the report warned.<br/><br/></p> <h2>Evolution of Avian Influenza Remains Hard to Predict</h2> <p>However, despite many occurrences of human exposure to avian influenza since 2020, “no symptomatic or productive infection in a human has been identified in the EU/EEA,” the scientists stated. Furthermore, after almost three decades of human exposure to the A(H5N1) virus of the Gs/GD lineage, the virus has not yet acquired the mutations required for airborne transmissibility between humans. However, it remains “difficult to predict the evolutionary direction the virus will take in the future,” the scientists assessed.<br/><br/>“Clearly, humans are being exposed in the <span class="Hyperlink"><a href="https://www.cdc.gov/media/releases/2024/p0401-avian-flu.html">current USA cattle outbreak</a></span>,” Professor James Wood, infectious disease epidemiologist at the University of Cambridge, United Kingdom, told this news organization. “But, arguably, what is more significant is how few cases there have been with this virus lineage and its close relatives, despite massive global exposures over the last 3 years. All diagnosed human cases seem to have been singletons, with no evidence of human-to-human transmission.”<br/><br/>Ian Jones, professor of virology at the University of Reading, United Kingdom, sees no evidence of an imminent spillover of avian influenza from birds. But he told this news organization: “The trouble is, the clock resets every minute. Every time the virus has come out of a bird and gone somewhere, the clock is reset. So you can never say that just because it hasn’t happened since whenever, it’s never going to happen.”<br/><br/> </p> <h2>Preventive Measures Recommended</h2> <p>The European report recommended a range of cautionary measures that included enhanced surveillance, access to rapid diagnostics, and sharing of genetic sequence data. It urged EU authorities to work together, adopting a <span class="Hyperlink"><a href="https://www.who.int/health-topics/one-health#tab=tab_1">One Health</a> </span>perspective, to limit the exposure of mammals, including humans, to avian influenza viruses. <br/><br/>Sarah Pitt, a microbiologist at the University of Brighton, United Kingdom, said the emphasis on authorities taking a One Health approach was sound. “You’re looking at humans, animals, plants, and the environment and how they’re all closely interacted,” she told this news organization. “Putting all those things together is actually going to be good for human health. So they’ve mentioned One Health a lot and I’m sure that’s on purpose because it’s the latest buzzword, and presumably it’s a way of getting governments to take it seriously.” <br/><br/>Overall, Dr. Pitt believes the document is designed to move zoonotic infectious diseases a bit higher up the agenda. “They should have been higher up the agenda before COVID,” she said.<br/><br/>The report also called for consideration of preventative measures, such as vaccination of poultry flocks. <br/><br/>Overall, Dr. Jones assesses the European report as “a reworking of what’s been pretty well covered over the years.” Despite extensive work by scientists in the field, he said: “I’m not sure we’re any better at predicting an emerging virus than we’ve ever been. I would point out that we didn’t spot SARS-CoV-2 coming, even though we had SARS-CoV-1 a few years earlier. Nobody spotted the 2009 pandemic from influenza, even though there was a lot of surveillance around at the time.”<br/><br/><br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/european-scientists-assess-avian-flu-pandemic-risk-2024a10006jh">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Hepatitis E Vaccine Shows Long-Term Efficacy

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Fri, 04/12/2024 - 13:03

The hepatitis E virus (HEV) is among the leading global causes of acute viral hepatitis. Molecular studies of HEV strains have identified four main genotypes. Genotypes 1 and 2 are limited to humans and are transmitted through contaminated water in resource-limited countries, mainly in Asia. Genotypes 3 and 4 are zoonotic, causing sporadic indigenous hepatitis E in nearly all countries.

Each year, approximately 20 million HEV infections occur worldwide, resulting in around 3.3 million symptomatic infections and 70,000 deaths. Despite this toll, HEV infection remains underestimated, and Western countries are likely not immune to the virus. To date, two recombinant vaccines against hepatitis E, based on genotype 1, have been developed and approved in China, but further studies are needed to determine the duration of vaccination protection.
 

Ten-Year Results

This study is an extension of a randomized, double-blind, placebo-controlled phase 3 clinical trial of the Hecolin hepatitis E vaccine that was conducted in Dongtai County, Jiangsu, China. In the initial trial, healthy adults aged 16-65 years were recruited, stratified by age and sex, and randomly assigned in a 1:1 ratio to receive three doses of intramuscular hepatitis E vaccine or placebo at months 0, 1, and 6.

A hepatitis E surveillance system, including 205 clinical sentinels covering the entire study region, was established before the study began and maintained for 10 years after vaccination to identify individuals with suspected hepatitis. In addition, an external control cohort was formed to assess vaccine efficacy. The primary endpoint was the vaccine’s efficacy in preventing confirmed hepatitis E occurring at least 30 days after the administration of the third vaccine dose.

Follow-up occurred every 3 months. Participants with hepatitis symptoms for 3 days or more underwent alanine aminotransferase (ALT) concentration measurement. Patients with ALT concentrations ≥ 2.5 times the upper limit of normal were considered to have acute hepatitis. A diagnosis of HEV-confirmed infection was made for patients with acute hepatitis presenting with at least two of the following markers: Presence of HEV RNA, presence of positive anti-HEV immunoglobulin (Ig) M antibodies, and at least fourfold increase in anti-HEV IgG concentrations.

For the efficacy analysis, a Poisson regression model was used to estimate the relative risk and its 95% CI of incidence between groups. Incidence was reported as the number of patients with hepatitis E per 10,000 person-years.

Immunogenicity persistence was assessed by measuring anti-HEV IgG in participants. Serum samples were collected at months 0, 7, 13, 19, 31, 43, 55, 79, and 103 for Qingdao district participants and at months 0, 7, 19, 31, 43, 67, and 91 for Anfeng district participants.
 

Efficacy and Duration

The follow-up period extended from 2007 to 2017. In total, 97,356 participants completed the three-dose regimen and were included in the per-protocol population (48,693 in the vaccine group and 48,663 in the placebo group), and 178,236 residents from the study region participated in the external control cohort. During the study period, 90 cases of hepatitis E were identified, with 13 in the vaccine group (0.2 per 10,000 person-years) and 77 in the placebo group (1.4 per 10,000 person-years). This indicated a vaccine efficacy of 86.6% in the per-protocol analysis.

In the subgroups evaluated for immunogenicity persistence, among those who were initially seronegative and received three doses of hepatitis E vaccine, 254 out of 291 vaccinated participants (87.3%) in Qingdao after 8.5 years and 1270 (73.0%) out of 1740 vaccinated participants in Anfeng after 7.5 years maintained detectable antibody concentrations.

The identification of infections despite vaccination is notable, especially with eight cases occurring beyond the fourth year following the last dose. This information is crucial for understanding potential immunity decline over time and highlights the importance of exploring various vaccination strategies to optimize protection.

An ongoing phase 4 clinical trial in Bangladesh, exploring different administration schedules and target populations, could help optimize vaccination strategies. The remarkable efficacy (100%) observed over a 30-month period for the two-dose schedule (doses are administered 1 month apart) is promising.

The observation of higher IgG antibody avidity in participants with infections despite vaccination underscores the importance of robust antibody responses to mitigate disease severity and duration. Several study limitations, such as lack of data on deaths and emigrations, a single-center study design, predominance of genotype 4 infections, and the risk for bias in the external control cohort, should be acknowledged.

In conclusion, this study provides compelling evidence of sustained protection of the hepatitis E vaccine over a decade. The observed persistence of induced antibodies for at least 8.5 years supports the long-term efficacy of the vaccine. Diverse global trials, further investigation into the impact of natural infections on vaccine-induced antibodies, and confirmation of inter-genotypic protection are needed.

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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The hepatitis E virus (HEV) is among the leading global causes of acute viral hepatitis. Molecular studies of HEV strains have identified four main genotypes. Genotypes 1 and 2 are limited to humans and are transmitted through contaminated water in resource-limited countries, mainly in Asia. Genotypes 3 and 4 are zoonotic, causing sporadic indigenous hepatitis E in nearly all countries.

Each year, approximately 20 million HEV infections occur worldwide, resulting in around 3.3 million symptomatic infections and 70,000 deaths. Despite this toll, HEV infection remains underestimated, and Western countries are likely not immune to the virus. To date, two recombinant vaccines against hepatitis E, based on genotype 1, have been developed and approved in China, but further studies are needed to determine the duration of vaccination protection.
 

Ten-Year Results

This study is an extension of a randomized, double-blind, placebo-controlled phase 3 clinical trial of the Hecolin hepatitis E vaccine that was conducted in Dongtai County, Jiangsu, China. In the initial trial, healthy adults aged 16-65 years were recruited, stratified by age and sex, and randomly assigned in a 1:1 ratio to receive three doses of intramuscular hepatitis E vaccine or placebo at months 0, 1, and 6.

A hepatitis E surveillance system, including 205 clinical sentinels covering the entire study region, was established before the study began and maintained for 10 years after vaccination to identify individuals with suspected hepatitis. In addition, an external control cohort was formed to assess vaccine efficacy. The primary endpoint was the vaccine’s efficacy in preventing confirmed hepatitis E occurring at least 30 days after the administration of the third vaccine dose.

Follow-up occurred every 3 months. Participants with hepatitis symptoms for 3 days or more underwent alanine aminotransferase (ALT) concentration measurement. Patients with ALT concentrations ≥ 2.5 times the upper limit of normal were considered to have acute hepatitis. A diagnosis of HEV-confirmed infection was made for patients with acute hepatitis presenting with at least two of the following markers: Presence of HEV RNA, presence of positive anti-HEV immunoglobulin (Ig) M antibodies, and at least fourfold increase in anti-HEV IgG concentrations.

For the efficacy analysis, a Poisson regression model was used to estimate the relative risk and its 95% CI of incidence between groups. Incidence was reported as the number of patients with hepatitis E per 10,000 person-years.

Immunogenicity persistence was assessed by measuring anti-HEV IgG in participants. Serum samples were collected at months 0, 7, 13, 19, 31, 43, 55, 79, and 103 for Qingdao district participants and at months 0, 7, 19, 31, 43, 67, and 91 for Anfeng district participants.
 

Efficacy and Duration

The follow-up period extended from 2007 to 2017. In total, 97,356 participants completed the three-dose regimen and were included in the per-protocol population (48,693 in the vaccine group and 48,663 in the placebo group), and 178,236 residents from the study region participated in the external control cohort. During the study period, 90 cases of hepatitis E were identified, with 13 in the vaccine group (0.2 per 10,000 person-years) and 77 in the placebo group (1.4 per 10,000 person-years). This indicated a vaccine efficacy of 86.6% in the per-protocol analysis.

In the subgroups evaluated for immunogenicity persistence, among those who were initially seronegative and received three doses of hepatitis E vaccine, 254 out of 291 vaccinated participants (87.3%) in Qingdao after 8.5 years and 1270 (73.0%) out of 1740 vaccinated participants in Anfeng after 7.5 years maintained detectable antibody concentrations.

The identification of infections despite vaccination is notable, especially with eight cases occurring beyond the fourth year following the last dose. This information is crucial for understanding potential immunity decline over time and highlights the importance of exploring various vaccination strategies to optimize protection.

An ongoing phase 4 clinical trial in Bangladesh, exploring different administration schedules and target populations, could help optimize vaccination strategies. The remarkable efficacy (100%) observed over a 30-month period for the two-dose schedule (doses are administered 1 month apart) is promising.

The observation of higher IgG antibody avidity in participants with infections despite vaccination underscores the importance of robust antibody responses to mitigate disease severity and duration. Several study limitations, such as lack of data on deaths and emigrations, a single-center study design, predominance of genotype 4 infections, and the risk for bias in the external control cohort, should be acknowledged.

In conclusion, this study provides compelling evidence of sustained protection of the hepatitis E vaccine over a decade. The observed persistence of induced antibodies for at least 8.5 years supports the long-term efficacy of the vaccine. Diverse global trials, further investigation into the impact of natural infections on vaccine-induced antibodies, and confirmation of inter-genotypic protection are needed.

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The hepatitis E virus (HEV) is among the leading global causes of acute viral hepatitis. Molecular studies of HEV strains have identified four main genotypes. Genotypes 1 and 2 are limited to humans and are transmitted through contaminated water in resource-limited countries, mainly in Asia. Genotypes 3 and 4 are zoonotic, causing sporadic indigenous hepatitis E in nearly all countries.

Each year, approximately 20 million HEV infections occur worldwide, resulting in around 3.3 million symptomatic infections and 70,000 deaths. Despite this toll, HEV infection remains underestimated, and Western countries are likely not immune to the virus. To date, two recombinant vaccines against hepatitis E, based on genotype 1, have been developed and approved in China, but further studies are needed to determine the duration of vaccination protection.
 

Ten-Year Results

This study is an extension of a randomized, double-blind, placebo-controlled phase 3 clinical trial of the Hecolin hepatitis E vaccine that was conducted in Dongtai County, Jiangsu, China. In the initial trial, healthy adults aged 16-65 years were recruited, stratified by age and sex, and randomly assigned in a 1:1 ratio to receive three doses of intramuscular hepatitis E vaccine or placebo at months 0, 1, and 6.

A hepatitis E surveillance system, including 205 clinical sentinels covering the entire study region, was established before the study began and maintained for 10 years after vaccination to identify individuals with suspected hepatitis. In addition, an external control cohort was formed to assess vaccine efficacy. The primary endpoint was the vaccine’s efficacy in preventing confirmed hepatitis E occurring at least 30 days after the administration of the third vaccine dose.

Follow-up occurred every 3 months. Participants with hepatitis symptoms for 3 days or more underwent alanine aminotransferase (ALT) concentration measurement. Patients with ALT concentrations ≥ 2.5 times the upper limit of normal were considered to have acute hepatitis. A diagnosis of HEV-confirmed infection was made for patients with acute hepatitis presenting with at least two of the following markers: Presence of HEV RNA, presence of positive anti-HEV immunoglobulin (Ig) M antibodies, and at least fourfold increase in anti-HEV IgG concentrations.

For the efficacy analysis, a Poisson regression model was used to estimate the relative risk and its 95% CI of incidence between groups. Incidence was reported as the number of patients with hepatitis E per 10,000 person-years.

Immunogenicity persistence was assessed by measuring anti-HEV IgG in participants. Serum samples were collected at months 0, 7, 13, 19, 31, 43, 55, 79, and 103 for Qingdao district participants and at months 0, 7, 19, 31, 43, 67, and 91 for Anfeng district participants.
 

Efficacy and Duration

The follow-up period extended from 2007 to 2017. In total, 97,356 participants completed the three-dose regimen and were included in the per-protocol population (48,693 in the vaccine group and 48,663 in the placebo group), and 178,236 residents from the study region participated in the external control cohort. During the study period, 90 cases of hepatitis E were identified, with 13 in the vaccine group (0.2 per 10,000 person-years) and 77 in the placebo group (1.4 per 10,000 person-years). This indicated a vaccine efficacy of 86.6% in the per-protocol analysis.

In the subgroups evaluated for immunogenicity persistence, among those who were initially seronegative and received three doses of hepatitis E vaccine, 254 out of 291 vaccinated participants (87.3%) in Qingdao after 8.5 years and 1270 (73.0%) out of 1740 vaccinated participants in Anfeng after 7.5 years maintained detectable antibody concentrations.

The identification of infections despite vaccination is notable, especially with eight cases occurring beyond the fourth year following the last dose. This information is crucial for understanding potential immunity decline over time and highlights the importance of exploring various vaccination strategies to optimize protection.

An ongoing phase 4 clinical trial in Bangladesh, exploring different administration schedules and target populations, could help optimize vaccination strategies. The remarkable efficacy (100%) observed over a 30-month period for the two-dose schedule (doses are administered 1 month apart) is promising.

The observation of higher IgG antibody avidity in participants with infections despite vaccination underscores the importance of robust antibody responses to mitigate disease severity and duration. Several study limitations, such as lack of data on deaths and emigrations, a single-center study design, predominance of genotype 4 infections, and the risk for bias in the external control cohort, should be acknowledged.

In conclusion, this study provides compelling evidence of sustained protection of the hepatitis E vaccine over a decade. The observed persistence of induced antibodies for at least 8.5 years supports the long-term efficacy of the vaccine. Diverse global trials, further investigation into the impact of natural infections on vaccine-induced antibodies, and confirmation of inter-genotypic protection are needed.

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167654</fileName> <TBEID>0C04F837.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F837</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240412T122819</QCDate> <firstPublished>20240412T130012</firstPublished> <LastPublished>20240412T130012</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240412T130012</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Alessia Melzani, MD</byline> <bylineText/> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>BY ALESSIA MELZANI, MD</metaDescription> <articlePDF/> <teaserImage/> <teaser>This study provides compelling evidence of sustained protection provided by the hepatitis E vaccine over a decade.</teaser> <title>Hepatitis E Vaccine Shows Long-Term Efficacy</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">20</term> <term>21</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>226</term> <term>234</term> <term canonical="true">314</term> <term>317</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Hepatitis E Vaccine Shows Long-Term Efficacy</title> <deck/> </itemMeta> <itemContent> <p>BY ALESSIA MELZANI, MD</p> <p>The <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/178140-overview">hepatitis E</a></span> virus (HEV) is among the leading global causes of acute <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/775507-overview">viral hepatitis</a></span>. Molecular studies of HEV strains have identified four main genotypes. Genotypes 1 and 2 are limited to humans and are transmitted through contaminated water in resource-limited countries, mainly in Asia. Genotypes 3 and 4 are zoonotic, causing sporadic indigenous hepatitis E in nearly all countries.</p> <p>Each year, approximately 20 million HEV infections occur worldwide, resulting in around 3.3 million symptomatic infections and 70,000 deaths. Despite this toll, HEV infection remains underestimated, and Western countries are likely not immune to the virus. To date, two recombinant vaccines against hepatitis E, based on genotype 1, have been developed and approved in China, but further studies are needed to determine the duration of vaccination protection.<br/><br/></p> <h2>Ten-Year Results</h2> <p>This study is an extension of a randomized, double-blind, placebo-controlled phase 3 clinical trial of the Hecolin hepatitis E vaccine that was conducted in Dongtai County, Jiangsu, China. In the initial trial, healthy adults aged 16-65 years were recruited, stratified by age and sex, and randomly assigned in a 1:1 ratio to receive three doses of intramuscular hepatitis E vaccine or placebo at months 0, 1, and 6.<br/><br/>A hepatitis E surveillance system, including 205 clinical sentinels covering the entire study region, was established before the study began and maintained for 10 years after vaccination to identify individuals with suspected hepatitis. In addition, an external control cohort was formed to assess vaccine efficacy. The primary endpoint was the vaccine’s efficacy in preventing confirmed hepatitis E occurring at least 30 days after the administration of the third vaccine dose.<br/><br/>Follow-up occurred every 3 months. Participants with hepatitis symptoms for 3 days or more underwent alanine aminotransferase (ALT) concentration measurement. Patients with ALT concentrations ≥ 2.5 times the upper limit of normal were considered to have acute hepatitis. A diagnosis of HEV-confirmed infection was made for patients with acute hepatitis presenting with at least two of the following markers: Presence of HEV RNA, presence of positive anti-HEV immunoglobulin (Ig) M antibodies, and at least fourfold increase in anti-HEV IgG concentrations.<br/><br/>For the efficacy analysis, a Poisson regression model was used to estimate the relative risk and its 95% CI of incidence between groups. Incidence was reported as the number of patients with hepatitis E per 10,000 person-years.<br/><br/>Immunogenicity persistence was assessed by measuring anti-HEV IgG in participants. Serum samples were collected at months 0, 7, 13, 19, 31, 43, 55, 79, and 103 for Qingdao district participants and at months 0, 7, 19, 31, 43, 67, and 91 for Anfeng district participants.<br/><br/></p> <h2>Efficacy and Duration</h2> <p>The follow-up period extended from 2007 to 2017. In total, 97,356 participants completed the three-dose regimen and were included in the per-protocol population (48,693 in the vaccine group and 48,663 in the placebo group), and 178,236 residents from the study region participated in the external control cohort. During the study period, 90 cases of hepatitis E were identified, with 13 in the vaccine group (0.2 per 10,000 person-years) and 77 in the placebo group (1.4 per 10,000 person-years). This indicated a vaccine efficacy of 86.6% in the per-protocol analysis.<br/><br/>In the subgroups evaluated for immunogenicity persistence, among those who were initially seronegative and received three doses of hepatitis E vaccine, 254 out of 291 vaccinated participants (87.3%) in Qingdao after 8.5 years and 1270 (73.0%) out of 1740 vaccinated participants in Anfeng after 7.5 years maintained detectable antibody concentrations.<br/><br/>The identification of infections despite vaccination is notable, especially with eight cases occurring beyond the fourth year following the last dose. This information is crucial for understanding potential immunity decline over time and highlights the importance of exploring various vaccination strategies to optimize protection.<br/><br/>An ongoing phase 4 clinical trial in Bangladesh, exploring different administration schedules and target populations, could help optimize vaccination strategies. The remarkable efficacy (100%) observed over a 30-month period for the two-dose schedule (doses are administered 1 month apart) is promising.<br/><br/>The observation of higher IgG antibody avidity in participants with infections despite vaccination underscores the importance of robust antibody responses to mitigate disease severity and duration. Several study limitations, such as lack of data on deaths and emigrations, a single-center study design, predominance of genotype 4 infections, and the risk for bias in the external control cohort, should be acknowledged.<br/><br/>In conclusion, this study provides compelling evidence of sustained protection of the hepatitis E vaccine over a decade. The observed persistence of induced antibodies for at least 8.5 years supports the long-term efficacy of the vaccine. Diverse global trials, further investigation into the impact of natural infections on vaccine-induced antibodies, and confirmation of inter-genotypic protection are needed.<span class="end"/></p> <p> <em>This story was translated <span class="Hyperlink"><a href="https://www.jim.fr/viewarticle/efficacit%C3%A9-%C3%A0-long-terme-d-vaccin-contre-2024a100045a">from JIM</a></span>, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/hepatitis-e-vaccine-shows-long-term-efficacy-2024a10006m1?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Oral Transmission of Chagas Disease Has Severe Effects

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Thanks to decades of successful vector control strategies, vector-borne transmission of Chagas disease has significantly decreased in many regions. Oral ingestion of Trypanosoma cruzi through contaminated food and beverages, however, is increasing. Unlike vector transmission, oral transmission of Chagas disease entails high lethality in pediatric and adult populations.

“The oral transmission of Chagas disease is becoming a much more recognized route, and it is crucial to understand that people can die from this type of transmission,” Norman L. Beatty, MD, assistant professor of infectious diseases and global medicine at the University of Florida College of Medicine in Gainesville, Florida, told this news organization. Dr. Beatty is the lead author of a recent article on the subject.

In regions where the parasite circulates in the environment, people are consuming foods, fruit juices, and possibly wild animal meat that may be contaminated. “As we experience changes in our environment and in the way we consume food, it is crucial to consider how food preparation is carried out in areas where T cruzi transmission occurs in the environment,” said Dr. Beatty. “And as organic farming methods without insecticides become increasingly common, more research is needed in these areas, both in Latin America and in the United States, to understand if oral transmission of T cruzi is occurring.”

In the Amazon basin, foodborne transmission is already the leading cause of acute Chagas disease. It has been described in Argentina, Bolivia, Brazil, Colombia, Ecuador, French Guiana, and Venezuela.

Dr. Beatty’s colleagues recently treated a Brazilian patient at the hospital in Florida. “He came to our hospital very ill, with acute myocarditis after consuming contaminated açaí.” Clarifying that there is widespread awareness about oral transmission in Brazil, he stated, “We are concerned that it may not be recognized in other areas of Latin America.”

Mexico and regions of Central America have little to no information on oral transmission, but it is likely occurring, and cases may be going undetected in the region, said Dr. Beatty.

He investigated the issue in Colombia as part of an international collaboration involving the University of Antioquia, aiming to find ways to mitigate oral transmission and create a model that can be used throughout Latin America and the United States. For the Colombia study, they reviewed all cases reported to the Ministry of Health and Social Protection, and oral transmission turned out to be more common than the research group expected. “Still, I imagine that in certain areas with limited resources…there are many more cases that are not being reported.

“A myth I would like to dispel is that Chagas disease is not being transmitted in the United States,” Dr. Beatty added. He mentioned that at least 30 American states have vectors, and in Florida, it was documented that triatomines invaded homes and bit residents. In addition, 30% of these insects are infected with T cruzi. Research is underway to determine whether Floridians are becoming infected and if they are also at risk of contracting Chagas disease orally, said Dr. Beatty. “In the United States, we know very little about how many people are infected and what the infection routes are. Much more research is needed.”

Roberto Chuit, MD, PhD, a doctor in public health and an external consultant for the Pan American Health Organization (PAHO), agreed that this route of food contamination, which occurs because of vector-borne parasites, was until recently masked or hidden by the predominance of vector presence. Just as it began to gain importance as other transmission routes were controlled, “it now has extremely high importance in the Americas, as does vertical transmission,” he said.

In 2023, more than 50 years after the first description of oral transmission, the PAHO expert meeting proposed to alert health services and the broader community about the severity and potential lethality of oral Chagas disease outbreaks to elicit immediate responses and mitigation measures. The body also proposed conducting studies to provide detailed information on the contamination source and the wild vectors present in oral transmission foci.
 

 

 

Unique Clinical Manifestations

The exacerbated signs and symptoms of oral infection (see sidebar) are attributed to the high parasite loads in contaminated food and beverages. A single crushed triatomine along with a food or beverage harboring T cruzi can contain an estimated 600,000 metacyclic trypomastigotes, compared with 3000-4000 per µL when infection occurs by triatomine fecal matter. The robust systemic immune response observed in patients with acute oral Chagas disease is thought to result from more efficient transmission after penetration through the oral, pharyngeal, and gastric mucosae.
 

Seven Things to Know About Orally Transmitted Chagas Disease

1. It presents with exacerbated symptoms and rapid disease progression in immunocompetent individuals. This presentation is not common in vector-borne, congenital, or transfusion-related transmission. It can cause fulminant myocarditis and heart failure, meningoencephalitis, or potentially fatal shock due to parasitemia.

2. Most patients (71%-100%) with acute oral Chagas present with fever.

3. Electrocardiographic abnormalities, specifically ventricular depolarization alterations and pericardial involvement, are observed in most patients.

4. Facial edema, which typically affects the entire face and parts of the lips, is present in 57%-100% of patients with acute oral Chagas disease. In those with acute symptoms from vector transmission, unilateral periorbital swelling (Romaña’s sign) is more common.

5. Other notable systemic symptoms include edema of the lower extremities, myalgia, generalized lymphadenopathy, abdominal discomfort, dyspnea, vomiting, diarrhea, hepatomegaly, splenomegaly, headache, chest pain, cutaneous erythematous rash, jaundice, arthralgia, epistaxis, hematemesis, melena, and palpitations.

6. The incubation period after oral ingestion of products contaminated with Trypanosoma cruzi is approximately 3-22 days, in contrast to 4-15 days for vector-borne transmission and 8-160 days for transfusion and transplant-related transmission.

7. Patients need antiparasitic drugs immediately.
 

Thinking Epidemiologically

Dr. Chuit recalled that suspicion of food contamination should be based on epidemiology, especially in outbreaks affecting several people and in regions where Chagas vectors have been described. Sometimes, however, a single careless tourist consumes contaminated products.

“The difficulty is that many times it is not considered, and if it is not considered, the search for the parasite is not requested,” said Dr. Chuit. He added that it is common for the professional to consider Chagas disease only if viral and bacterial isolation tests are negative. Clinicians sometimes consider Chagas disease because the patient has not responded to regular treatments for other causes, such as antibiotics and hydration.

Epidemiology is important, especially when Chagas disease is diagnosed in groups or a family, because they are usually not isolated cases but outbreaks of 3-40 cases, according to Dr. Chuit. “Under these conditions, it must be quickly considered…that this parasite may be involved.”

One of the difficulties is that the source of these oral transmissions is not recognized most of the time. In general, the sources are usually foods that are more likely to be contaminated by insects or insect feces, such as orange juice or sugarcane. But in fact, any food or beverage left unattended could be contaminated by vectors or possible secretions from infected marsupial odoriferous glands.

An analysis of 32 outbreaks from 1965 to 2022 showed that the main foods involved in oral transmission were homemade fruit juices. But different vector species were identified, and the reservoirs were mainly dogs, rodents, and large American opossums (Didelphis).

The largest oral Chagas outbreak was linked to the consumption of contaminated guava juice in a primary school in Caracas, Venezuela. Nonindustrially produced açaí is a common source of orally acquired Chagas disease in Brazil. In Colombia, Chagas disease has been associated with the consumption of palm wine, sugar cane, and tangerine juice. Other oral transmission routes include consuming meat from wild animals and ingesting blood from infected armadillos, which is related to a traditional medicine practice.
 

 

 

Deadly Yet Easily Treatable

In the outbreak of 119 confirmed and suspected cases in Venezuela, 20.3% required hospitalization, and a 5-year-old child died of acute myocarditis. These percentages differ from those reported in vector transmission, which is asymptomatic in the acute phase for 95%-99% of cases or will only develop a mild febrile illness that resolves on its own.

“Not all cases will present as severe, because depending on the inoculum, there may be individuals with subclinical situations. But any food poisoning that occurs in endemic areas, where food is not properly controlled, and these street foods are associated with processes in jungle areas, raises the possibility that T cruzi is involved and should be considered as a differential diagnosis,» noted Dr. Chuit. “The treatment is highly effective, and people recover quickly.”

“The most important thing about oral transmission of Chagas is that someone infected in this way needs antiparasitic drugs immediately. We can cure them if we treat them immediately,” said Dr. Beatty, adding that treatment is sometimes delayed due to lack of access to appropriate antiparasitic drugs. “Here in the United States and in Latin America, it is quite common for healthcare professionals not to understand the differences between vector, vertical, and oral transmission. By not treating these patients, they become ill quickly.”

Dr. Beatty and Dr. Chuit declared no relevant financial conflicts of interest.

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Thanks to decades of successful vector control strategies, vector-borne transmission of Chagas disease has significantly decreased in many regions. Oral ingestion of Trypanosoma cruzi through contaminated food and beverages, however, is increasing. Unlike vector transmission, oral transmission of Chagas disease entails high lethality in pediatric and adult populations.

“The oral transmission of Chagas disease is becoming a much more recognized route, and it is crucial to understand that people can die from this type of transmission,” Norman L. Beatty, MD, assistant professor of infectious diseases and global medicine at the University of Florida College of Medicine in Gainesville, Florida, told this news organization. Dr. Beatty is the lead author of a recent article on the subject.

In regions where the parasite circulates in the environment, people are consuming foods, fruit juices, and possibly wild animal meat that may be contaminated. “As we experience changes in our environment and in the way we consume food, it is crucial to consider how food preparation is carried out in areas where T cruzi transmission occurs in the environment,” said Dr. Beatty. “And as organic farming methods without insecticides become increasingly common, more research is needed in these areas, both in Latin America and in the United States, to understand if oral transmission of T cruzi is occurring.”

In the Amazon basin, foodborne transmission is already the leading cause of acute Chagas disease. It has been described in Argentina, Bolivia, Brazil, Colombia, Ecuador, French Guiana, and Venezuela.

Dr. Beatty’s colleagues recently treated a Brazilian patient at the hospital in Florida. “He came to our hospital very ill, with acute myocarditis after consuming contaminated açaí.” Clarifying that there is widespread awareness about oral transmission in Brazil, he stated, “We are concerned that it may not be recognized in other areas of Latin America.”

Mexico and regions of Central America have little to no information on oral transmission, but it is likely occurring, and cases may be going undetected in the region, said Dr. Beatty.

He investigated the issue in Colombia as part of an international collaboration involving the University of Antioquia, aiming to find ways to mitigate oral transmission and create a model that can be used throughout Latin America and the United States. For the Colombia study, they reviewed all cases reported to the Ministry of Health and Social Protection, and oral transmission turned out to be more common than the research group expected. “Still, I imagine that in certain areas with limited resources…there are many more cases that are not being reported.

“A myth I would like to dispel is that Chagas disease is not being transmitted in the United States,” Dr. Beatty added. He mentioned that at least 30 American states have vectors, and in Florida, it was documented that triatomines invaded homes and bit residents. In addition, 30% of these insects are infected with T cruzi. Research is underway to determine whether Floridians are becoming infected and if they are also at risk of contracting Chagas disease orally, said Dr. Beatty. “In the United States, we know very little about how many people are infected and what the infection routes are. Much more research is needed.”

Roberto Chuit, MD, PhD, a doctor in public health and an external consultant for the Pan American Health Organization (PAHO), agreed that this route of food contamination, which occurs because of vector-borne parasites, was until recently masked or hidden by the predominance of vector presence. Just as it began to gain importance as other transmission routes were controlled, “it now has extremely high importance in the Americas, as does vertical transmission,” he said.

In 2023, more than 50 years after the first description of oral transmission, the PAHO expert meeting proposed to alert health services and the broader community about the severity and potential lethality of oral Chagas disease outbreaks to elicit immediate responses and mitigation measures. The body also proposed conducting studies to provide detailed information on the contamination source and the wild vectors present in oral transmission foci.
 

 

 

Unique Clinical Manifestations

The exacerbated signs and symptoms of oral infection (see sidebar) are attributed to the high parasite loads in contaminated food and beverages. A single crushed triatomine along with a food or beverage harboring T cruzi can contain an estimated 600,000 metacyclic trypomastigotes, compared with 3000-4000 per µL when infection occurs by triatomine fecal matter. The robust systemic immune response observed in patients with acute oral Chagas disease is thought to result from more efficient transmission after penetration through the oral, pharyngeal, and gastric mucosae.
 

Seven Things to Know About Orally Transmitted Chagas Disease

1. It presents with exacerbated symptoms and rapid disease progression in immunocompetent individuals. This presentation is not common in vector-borne, congenital, or transfusion-related transmission. It can cause fulminant myocarditis and heart failure, meningoencephalitis, or potentially fatal shock due to parasitemia.

2. Most patients (71%-100%) with acute oral Chagas present with fever.

3. Electrocardiographic abnormalities, specifically ventricular depolarization alterations and pericardial involvement, are observed in most patients.

4. Facial edema, which typically affects the entire face and parts of the lips, is present in 57%-100% of patients with acute oral Chagas disease. In those with acute symptoms from vector transmission, unilateral periorbital swelling (Romaña’s sign) is more common.

5. Other notable systemic symptoms include edema of the lower extremities, myalgia, generalized lymphadenopathy, abdominal discomfort, dyspnea, vomiting, diarrhea, hepatomegaly, splenomegaly, headache, chest pain, cutaneous erythematous rash, jaundice, arthralgia, epistaxis, hematemesis, melena, and palpitations.

6. The incubation period after oral ingestion of products contaminated with Trypanosoma cruzi is approximately 3-22 days, in contrast to 4-15 days for vector-borne transmission and 8-160 days for transfusion and transplant-related transmission.

7. Patients need antiparasitic drugs immediately.
 

Thinking Epidemiologically

Dr. Chuit recalled that suspicion of food contamination should be based on epidemiology, especially in outbreaks affecting several people and in regions where Chagas vectors have been described. Sometimes, however, a single careless tourist consumes contaminated products.

“The difficulty is that many times it is not considered, and if it is not considered, the search for the parasite is not requested,” said Dr. Chuit. He added that it is common for the professional to consider Chagas disease only if viral and bacterial isolation tests are negative. Clinicians sometimes consider Chagas disease because the patient has not responded to regular treatments for other causes, such as antibiotics and hydration.

Epidemiology is important, especially when Chagas disease is diagnosed in groups or a family, because they are usually not isolated cases but outbreaks of 3-40 cases, according to Dr. Chuit. “Under these conditions, it must be quickly considered…that this parasite may be involved.”

One of the difficulties is that the source of these oral transmissions is not recognized most of the time. In general, the sources are usually foods that are more likely to be contaminated by insects or insect feces, such as orange juice or sugarcane. But in fact, any food or beverage left unattended could be contaminated by vectors or possible secretions from infected marsupial odoriferous glands.

An analysis of 32 outbreaks from 1965 to 2022 showed that the main foods involved in oral transmission were homemade fruit juices. But different vector species were identified, and the reservoirs were mainly dogs, rodents, and large American opossums (Didelphis).

The largest oral Chagas outbreak was linked to the consumption of contaminated guava juice in a primary school in Caracas, Venezuela. Nonindustrially produced açaí is a common source of orally acquired Chagas disease in Brazil. In Colombia, Chagas disease has been associated with the consumption of palm wine, sugar cane, and tangerine juice. Other oral transmission routes include consuming meat from wild animals and ingesting blood from infected armadillos, which is related to a traditional medicine practice.
 

 

 

Deadly Yet Easily Treatable

In the outbreak of 119 confirmed and suspected cases in Venezuela, 20.3% required hospitalization, and a 5-year-old child died of acute myocarditis. These percentages differ from those reported in vector transmission, which is asymptomatic in the acute phase for 95%-99% of cases or will only develop a mild febrile illness that resolves on its own.

“Not all cases will present as severe, because depending on the inoculum, there may be individuals with subclinical situations. But any food poisoning that occurs in endemic areas, where food is not properly controlled, and these street foods are associated with processes in jungle areas, raises the possibility that T cruzi is involved and should be considered as a differential diagnosis,» noted Dr. Chuit. “The treatment is highly effective, and people recover quickly.”

“The most important thing about oral transmission of Chagas is that someone infected in this way needs antiparasitic drugs immediately. We can cure them if we treat them immediately,” said Dr. Beatty, adding that treatment is sometimes delayed due to lack of access to appropriate antiparasitic drugs. “Here in the United States and in Latin America, it is quite common for healthcare professionals not to understand the differences between vector, vertical, and oral transmission. By not treating these patients, they become ill quickly.”

Dr. Beatty and Dr. Chuit declared no relevant financial conflicts of interest.

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Thanks to decades of successful vector control strategies, vector-borne transmission of Chagas disease has significantly decreased in many regions. Oral ingestion of Trypanosoma cruzi through contaminated food and beverages, however, is increasing. Unlike vector transmission, oral transmission of Chagas disease entails high lethality in pediatric and adult populations.

“The oral transmission of Chagas disease is becoming a much more recognized route, and it is crucial to understand that people can die from this type of transmission,” Norman L. Beatty, MD, assistant professor of infectious diseases and global medicine at the University of Florida College of Medicine in Gainesville, Florida, told this news organization. Dr. Beatty is the lead author of a recent article on the subject.

In regions where the parasite circulates in the environment, people are consuming foods, fruit juices, and possibly wild animal meat that may be contaminated. “As we experience changes in our environment and in the way we consume food, it is crucial to consider how food preparation is carried out in areas where T cruzi transmission occurs in the environment,” said Dr. Beatty. “And as organic farming methods without insecticides become increasingly common, more research is needed in these areas, both in Latin America and in the United States, to understand if oral transmission of T cruzi is occurring.”

In the Amazon basin, foodborne transmission is already the leading cause of acute Chagas disease. It has been described in Argentina, Bolivia, Brazil, Colombia, Ecuador, French Guiana, and Venezuela.

Dr. Beatty’s colleagues recently treated a Brazilian patient at the hospital in Florida. “He came to our hospital very ill, with acute myocarditis after consuming contaminated açaí.” Clarifying that there is widespread awareness about oral transmission in Brazil, he stated, “We are concerned that it may not be recognized in other areas of Latin America.”

Mexico and regions of Central America have little to no information on oral transmission, but it is likely occurring, and cases may be going undetected in the region, said Dr. Beatty.

He investigated the issue in Colombia as part of an international collaboration involving the University of Antioquia, aiming to find ways to mitigate oral transmission and create a model that can be used throughout Latin America and the United States. For the Colombia study, they reviewed all cases reported to the Ministry of Health and Social Protection, and oral transmission turned out to be more common than the research group expected. “Still, I imagine that in certain areas with limited resources…there are many more cases that are not being reported.

“A myth I would like to dispel is that Chagas disease is not being transmitted in the United States,” Dr. Beatty added. He mentioned that at least 30 American states have vectors, and in Florida, it was documented that triatomines invaded homes and bit residents. In addition, 30% of these insects are infected with T cruzi. Research is underway to determine whether Floridians are becoming infected and if they are also at risk of contracting Chagas disease orally, said Dr. Beatty. “In the United States, we know very little about how many people are infected and what the infection routes are. Much more research is needed.”

Roberto Chuit, MD, PhD, a doctor in public health and an external consultant for the Pan American Health Organization (PAHO), agreed that this route of food contamination, which occurs because of vector-borne parasites, was until recently masked or hidden by the predominance of vector presence. Just as it began to gain importance as other transmission routes were controlled, “it now has extremely high importance in the Americas, as does vertical transmission,” he said.

In 2023, more than 50 years after the first description of oral transmission, the PAHO expert meeting proposed to alert health services and the broader community about the severity and potential lethality of oral Chagas disease outbreaks to elicit immediate responses and mitigation measures. The body also proposed conducting studies to provide detailed information on the contamination source and the wild vectors present in oral transmission foci.
 

 

 

Unique Clinical Manifestations

The exacerbated signs and symptoms of oral infection (see sidebar) are attributed to the high parasite loads in contaminated food and beverages. A single crushed triatomine along with a food or beverage harboring T cruzi can contain an estimated 600,000 metacyclic trypomastigotes, compared with 3000-4000 per µL when infection occurs by triatomine fecal matter. The robust systemic immune response observed in patients with acute oral Chagas disease is thought to result from more efficient transmission after penetration through the oral, pharyngeal, and gastric mucosae.
 

Seven Things to Know About Orally Transmitted Chagas Disease

1. It presents with exacerbated symptoms and rapid disease progression in immunocompetent individuals. This presentation is not common in vector-borne, congenital, or transfusion-related transmission. It can cause fulminant myocarditis and heart failure, meningoencephalitis, or potentially fatal shock due to parasitemia.

2. Most patients (71%-100%) with acute oral Chagas present with fever.

3. Electrocardiographic abnormalities, specifically ventricular depolarization alterations and pericardial involvement, are observed in most patients.

4. Facial edema, which typically affects the entire face and parts of the lips, is present in 57%-100% of patients with acute oral Chagas disease. In those with acute symptoms from vector transmission, unilateral periorbital swelling (Romaña’s sign) is more common.

5. Other notable systemic symptoms include edema of the lower extremities, myalgia, generalized lymphadenopathy, abdominal discomfort, dyspnea, vomiting, diarrhea, hepatomegaly, splenomegaly, headache, chest pain, cutaneous erythematous rash, jaundice, arthralgia, epistaxis, hematemesis, melena, and palpitations.

6. The incubation period after oral ingestion of products contaminated with Trypanosoma cruzi is approximately 3-22 days, in contrast to 4-15 days for vector-borne transmission and 8-160 days for transfusion and transplant-related transmission.

7. Patients need antiparasitic drugs immediately.
 

Thinking Epidemiologically

Dr. Chuit recalled that suspicion of food contamination should be based on epidemiology, especially in outbreaks affecting several people and in regions where Chagas vectors have been described. Sometimes, however, a single careless tourist consumes contaminated products.

“The difficulty is that many times it is not considered, and if it is not considered, the search for the parasite is not requested,” said Dr. Chuit. He added that it is common for the professional to consider Chagas disease only if viral and bacterial isolation tests are negative. Clinicians sometimes consider Chagas disease because the patient has not responded to regular treatments for other causes, such as antibiotics and hydration.

Epidemiology is important, especially when Chagas disease is diagnosed in groups or a family, because they are usually not isolated cases but outbreaks of 3-40 cases, according to Dr. Chuit. “Under these conditions, it must be quickly considered…that this parasite may be involved.”

One of the difficulties is that the source of these oral transmissions is not recognized most of the time. In general, the sources are usually foods that are more likely to be contaminated by insects or insect feces, such as orange juice or sugarcane. But in fact, any food or beverage left unattended could be contaminated by vectors or possible secretions from infected marsupial odoriferous glands.

An analysis of 32 outbreaks from 1965 to 2022 showed that the main foods involved in oral transmission were homemade fruit juices. But different vector species were identified, and the reservoirs were mainly dogs, rodents, and large American opossums (Didelphis).

The largest oral Chagas outbreak was linked to the consumption of contaminated guava juice in a primary school in Caracas, Venezuela. Nonindustrially produced açaí is a common source of orally acquired Chagas disease in Brazil. In Colombia, Chagas disease has been associated with the consumption of palm wine, sugar cane, and tangerine juice. Other oral transmission routes include consuming meat from wild animals and ingesting blood from infected armadillos, which is related to a traditional medicine practice.
 

 

 

Deadly Yet Easily Treatable

In the outbreak of 119 confirmed and suspected cases in Venezuela, 20.3% required hospitalization, and a 5-year-old child died of acute myocarditis. These percentages differ from those reported in vector transmission, which is asymptomatic in the acute phase for 95%-99% of cases or will only develop a mild febrile illness that resolves on its own.

“Not all cases will present as severe, because depending on the inoculum, there may be individuals with subclinical situations. But any food poisoning that occurs in endemic areas, where food is not properly controlled, and these street foods are associated with processes in jungle areas, raises the possibility that T cruzi is involved and should be considered as a differential diagnosis,» noted Dr. Chuit. “The treatment is highly effective, and people recover quickly.”

“The most important thing about oral transmission of Chagas is that someone infected in this way needs antiparasitic drugs immediately. We can cure them if we treat them immediately,” said Dr. Beatty, adding that treatment is sometimes delayed due to lack of access to appropriate antiparasitic drugs. “Here in the United States and in Latin America, it is quite common for healthcare professionals not to understand the differences between vector, vertical, and oral transmission. By not treating these patients, they become ill quickly.”

Dr. Beatty and Dr. Chuit declared no relevant financial conflicts of interest.

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167157</fileName> <TBEID>0C04ED9B.SIG</TBEID> <TBUniqueIdentifier>MD_0C04ED9B</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240304T142211</QCDate> <firstPublished>20240304T150045</firstPublished> <LastPublished>20240304T150045</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240304T150044</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Roxana Tabakman</byline> <bylineText>ROXANA TABAKMAN</bylineText> <bylineFull>ROXANA TABAKMAN</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Thanks to decades of successful vector control strategies, vector-borne transmission of Chagas disease has significantly decreased in many regions. Oral ingesti</metaDescription> <articlePDF/> <teaserImage/> <title>Oral Transmission of Chagas Disease Has Severe Effects</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>5</term> <term>15</term> <term canonical="true">20</term> <term>21</term> <term>25</term> </publications> <sections> <term>27980</term> <term canonical="true">39313</term> </sections> <topics> <term>173</term> <term>234</term> <term>285</term> <term canonical="true">317</term> <term>50736</term> <term>316</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Oral Transmission of Chagas Disease Has Severe Effects</title> <deck/> </itemMeta> <itemContent> <p><br/><br/>Thanks to decades of successful vector control strategies, vector-borne transmission of Chagas disease has significantly decreased in many regions. Oral ingestion of <em>Trypanosoma cruzi</em> through contaminated food and beverages, however, is increasing. Unlike vector transmission, oral transmission of Chagas disease entails high lethality in pediatric and adult populations.<br/><br/>“The oral transmission of Chagas disease is becoming a much more recognized route, and it is crucial to understand that people can die from this type of transmission,” Norman L. Beatty, MD, assistant professor of infectious diseases and global medicine at the University of Florida College of Medicine in Gainesville, Florida, told this news organization. Dr. Beatty is the lead author of a recent article on the subject.<br/><br/>In regions where the parasite circulates in the environment, people are consuming foods, fruit juices, and possibly wild animal meat that may be contaminated. “As we experience changes in our environment and in the way we consume food, it is crucial to consider how food preparation is carried out in areas where <em>T cruzi</em> transmission occurs in the environment,” said Dr. Beatty. “And as organic farming methods without insecticides become increasingly common, more research is needed in these areas, both in Latin America and in the United States, to understand if oral transmission of<em> T cruzi</em> is occurring.”<br/><br/>In the Amazon basin, foodborne transmission is already the leading cause of acute Chagas disease. It has been described in Argentina, Bolivia, Brazil, Colombia, Ecuador, French Guiana, and Venezuela.<br/><br/>Dr. Beatty’s colleagues recently treated a Brazilian patient at the hospital in Florida. “He came to our hospital very ill, with acute <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/156330-overview">myocarditis</a></span> after consuming contaminated açaí.” Clarifying that there is widespread awareness about oral transmission in Brazil, he stated, “We are concerned that it may not be recognized in other areas of Latin America.”<br/><br/>Mexico and regions of Central America have little to no information on oral transmission, but it is likely occurring, and cases may be going undetected in the region, said Dr. Beatty.<br/><br/>He investigated the issue in Colombia as part of an international collaboration involving the University of Antioquia, aiming to find ways to mitigate oral transmission and create a model that can be used throughout Latin America and the United States. For the Colombia study, they reviewed all cases reported to the Ministry of Health and Social Protection, and oral transmission turned out to be more common than the research group expected. “Still, I imagine that in certain areas with limited resources…there are many more cases that are not being reported.<br/><br/>“A myth I would like to dispel is that Chagas disease is not being transmitted in the United States,” Dr. Beatty added. He mentioned that at least 30 American states have vectors, and in Florida, it was documented that triatomines invaded homes and bit residents. In addition, 30% of these insects are infected with <em>T cruzi</em>. Research is underway to determine whether Floridians are becoming infected and if they are also at risk of contracting Chagas disease orally, said Dr. Beatty. “In the United States, we know very little about how many people are infected and what the infection routes are. Much more research is needed.”<br/><br/>Roberto Chuit, MD, PhD, a doctor in public health and an external consultant for the Pan American Health Organization (PAHO), agreed that this route of food contamination, which occurs because of vector-borne parasites, was until recently masked or hidden by the predominance of vector presence. Just as it began to gain importance as other transmission routes were controlled, “it now has extremely high importance in the Americas, as does vertical transmission,” he said.<br/><br/>In 2023, more than 50 years after the first description of oral transmission, the PAHO expert meeting proposed to alert health services and the broader community about the severity and potential lethality of oral Chagas disease outbreaks to elicit immediate responses and mitigation measures. The body also proposed conducting studies to provide detailed information on the contamination source and the wild vectors present in oral transmission foci.<br/><br/></p> <h2>Unique Clinical Manifestations</h2> <p>The exacerbated signs and symptoms of oral infection (see sidebar) are attributed to the high parasite loads in contaminated food and beverages. A single crushed triatomine along with a food or beverage harboring <em>T cruzi</em> can contain an estimated 600,000 metacyclic trypomastigotes, compared with 3000-4000 per µL when infection occurs by triatomine fecal matter. The robust systemic immune response observed in patients with acute oral Chagas disease is thought to result from more efficient transmission after penetration through the oral, pharyngeal, and gastric mucosae.<br/><br/></p> <h2>Seven Things to Know About Orally Transmitted Chagas Disease</h2> <p>1. It presents with exacerbated symptoms and rapid disease progression in immunocompetent individuals. This presentation is not common in vector-borne, congenital, or transfusion-related transmission. It can cause fulminant myocarditis and heart failure, meningoencephalitis, or potentially fatal shock due to parasitemia.<br/><br/>2. Most patients (71%-100%) with acute oral Chagas present with fever.<br/><br/>3. Electrocardiographic abnormalities, specifically ventricular depolarization alterations and pericardial involvement, are observed in most patients.<br/><br/>4. Facial edema, which typically affects the entire face and parts of the lips, is present in 57%-100% of patients with acute oral Chagas disease. In those with acute symptoms from vector transmission, unilateral periorbital swelling (Romaña’s sign) is more common.<br/><br/>5. Other notable systemic symptoms include edema of the lower extremities, myalgia, generalized lymphadenopathy, abdominal discomfort, dyspnea, vomiting, diarrhea, hepatomegaly, splenomegaly, headache, chest pain, cutaneous erythematous rash, jaundice, arthralgia, epistaxis, hematemesis, melena, and palpitations.<br/><br/>6. The incubation period after oral ingestion of products contaminated with <em>Trypanosoma cruzi </em>is approximately 3-22 days, in contrast to 4-15 days for vector-borne transmission and 8-160 days for transfusion and transplant-related transmission.<br/><br/>7. Patients need antiparasitic drugs immediately.<br/><br/></p> <h2>Thinking Epidemiologically</h2> <p>Dr. Chuit recalled that suspicion of food contamination should be based on epidemiology, especially in outbreaks affecting several people and in regions where Chagas vectors have been described. Sometimes, however, a single careless tourist consumes contaminated products.<br/><br/>“The difficulty is that many times it is not considered, and if it is not considered, the search for the parasite is not requested,” said Dr. Chuit. He added that it is common for the professional to consider Chagas disease only if viral and bacterial isolation tests are negative. Clinicians sometimes consider Chagas disease because the patient has not responded to regular treatments for other causes, such as antibiotics and hydration.<br/><br/>Epidemiology is important, especially when Chagas disease is diagnosed in groups or a family, because they are usually not isolated cases but outbreaks of 3-40 cases, according to Dr. Chuit. “Under these conditions, it must be quickly considered…that this parasite may be involved.”<br/><br/>One of the difficulties is that the source of these oral transmissions is not recognized most of the time. In general, the sources are usually foods that are more likely to be contaminated by insects or insect feces, such as orange juice or sugarcane. But in fact, any food or beverage left unattended could be contaminated by vectors or possible secretions from infected marsupial odoriferous glands.<br/><br/>An analysis of 32 outbreaks from 1965 to 2022 showed that the main foods involved in oral transmission were homemade fruit juices. But different vector species were identified, and the reservoirs were mainly dogs, rodents, and large American opossums (<span class="Emphasis">Didelphis</span>).<br/><br/>The largest oral Chagas outbreak was linked to the consumption of contaminated guava juice in a primary school in Caracas, Venezuela. Nonindustrially produced açaí is a common source of orally acquired Chagas disease in Brazil. In Colombia, Chagas disease has been associated with the consumption of palm wine, sugar cane, and tangerine juice. Other oral transmission routes include consuming meat from wild animals and ingesting blood from infected armadillos, which is related to a traditional medicine practice.<br/><br/></p> <h2>Deadly Yet Easily Treatable</h2> <p>In the outbreak of 119 confirmed and suspected cases in Venezuela, 20.3% required hospitalization, and a 5-year-old child died of acute myocarditis. These percentages differ from those reported in vector transmission, which is asymptomatic in the acute phase for 95%-99% of cases or will only develop a mild febrile illness that resolves on its own.<br/><br/>“Not all cases will present as severe, because depending on the inoculum, there may be individuals with subclinical situations. But any <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/175569-overview">food poisoning</a></span> that occurs in endemic areas, where food is not properly controlled, and these street foods are associated with processes in jungle areas, raises the possibility that <span class="Emphasis">T cruzi</span> is involved and should be considered as a differential diagnosis,» noted Dr. Chuit. “The treatment is highly effective, and people recover quickly.”<br/><br/>“The most important thing about oral transmission of Chagas is that someone infected in this way needs antiparasitic drugs immediately. We can cure them if we treat them immediately,” said Dr. Beatty, adding that treatment is sometimes delayed due to lack of access to appropriate antiparasitic drugs. “Here in the United States and in Latin America, it is quite common for healthcare professionals not to understand the differences between vector, vertical, and oral transmission. By not treating these patients, they become ill quickly.”<br/><br/>Dr. Beatty and Dr. Chuit declared no relevant financial conflicts of interest.</p> <p> <em><span class="Emphasis">This story was translated from the</span> <span class="Emphasis"><a href="https://espanol.medscape.com/verarticulo/5912078">Medscape Spanish edition</a> using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on </span><span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/oral-transmission-chagas-disease-has-severe-effects-2024a100042f">Medscape.com</a></span><span class="Emphasis">.</span></em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>“A myth I would like to dispel is that Chagas disease is not being transmitted in the United States.”</p> </itemContent> </newsItem> </itemSet></root>
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Curbing Antibiotic Use Works

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Mon, 02/26/2024 - 12:38

A decline in antibiotic-resistant bacteria has been observed in European countries that have curbed the use of antibiotics in both animals and humans, revealed the fourth joint interagency antimicrobial consumption and resistance analysis report.

The report was published by the European Centre for Disease Prevention and Control, the European Food Safety Authority, and the European Medicines Agency. Its findings were derived from an integrated analysis of the potential relationship between antimicrobial consumption (AMC) by humans and animals and the occurrence of antimicrobial resistance (AMR) using data collected between 2019 and 2021.
 

A Real Threat

AMR poses a significant threat to public and animal health, causing more than 35,000 deaths annually in the European Union (EU) and the European Economic Area. It also imposes a substantial economic burden on European healthcare systems, amounting to approximately €11.7 billion per year.

To address this challenge, the Council of the European Union recommended concerted and sustained efforts to achieve a 20% reduction in AMC in humans (compared with 2019 levels) and a 50% reduction in food-producing animals (compared with 2018 levels) by 2030. These targets are outlined in the European Commission’s Farm to Fork strategy.
 

It Really Works

Analysis of the trends of AMC and AMR in Escherichia coli from humans and food-producing animals, conducted for the first time, revealed that the susceptibility of E coli to antimicrobials in humans and animals increases with an overall decrease in the consumption of antibiotics.

Concurrent trends in AMC and AMR from 2014 to 2021 were also assessed. AMC in both human and animal sectors, measured in mg/kg of estimated biomass, was compared at country and European levels. In 2021, human AMC totaled 125.0 mg/kg of biomass, while food-producing animals registered 92.6 mg/kg of biomass.

Over the 2014-2021 period, total AMC in food-producing animals decreased by 44%, while in humans, it remained relatively stable. The consumption of certain antimicrobials was positively associated with resistance to those substances in bacteria from both humans and food-producing animals.

The report also highlighted that E coli resistance is linked in humans to the use of carbapenems, third- and fourth-generation cephalosporins, and quinolones and in food-producing animals to the administration of quinolones, polymyxins, aminopenicillins, and tetracyclines. Further, a connection exists between bacterial resistance in humans and food-producing animals, particularly for bacterial species such as Campylobacter jejuni and C coli.

The findings suggest that measures to reduce AMC in both food-producing animals and humans have been effective in many countries. However, reinforcing these measures is crucial to maintain and further advance reductions in AMC.
 

More Work

Aligned with the European Commission’s One Health holistic and coordinated approach to managing the human and veterinary sectors together, the European agencies advocate for:

  • Sustained efforts to combat AMR at national, EU, and global levels.
  • Coordinated surveillance of antibiotic use and AMR in both human and animal sectors.
  • Continued research in the field of AMR.

The statistical code used to conduct these analyses was made publicly available in order to support further research analyses.
 

A version of this article appeared on Medscape.com.

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A decline in antibiotic-resistant bacteria has been observed in European countries that have curbed the use of antibiotics in both animals and humans, revealed the fourth joint interagency antimicrobial consumption and resistance analysis report.

The report was published by the European Centre for Disease Prevention and Control, the European Food Safety Authority, and the European Medicines Agency. Its findings were derived from an integrated analysis of the potential relationship between antimicrobial consumption (AMC) by humans and animals and the occurrence of antimicrobial resistance (AMR) using data collected between 2019 and 2021.
 

A Real Threat

AMR poses a significant threat to public and animal health, causing more than 35,000 deaths annually in the European Union (EU) and the European Economic Area. It also imposes a substantial economic burden on European healthcare systems, amounting to approximately €11.7 billion per year.

To address this challenge, the Council of the European Union recommended concerted and sustained efforts to achieve a 20% reduction in AMC in humans (compared with 2019 levels) and a 50% reduction in food-producing animals (compared with 2018 levels) by 2030. These targets are outlined in the European Commission’s Farm to Fork strategy.
 

It Really Works

Analysis of the trends of AMC and AMR in Escherichia coli from humans and food-producing animals, conducted for the first time, revealed that the susceptibility of E coli to antimicrobials in humans and animals increases with an overall decrease in the consumption of antibiotics.

Concurrent trends in AMC and AMR from 2014 to 2021 were also assessed. AMC in both human and animal sectors, measured in mg/kg of estimated biomass, was compared at country and European levels. In 2021, human AMC totaled 125.0 mg/kg of biomass, while food-producing animals registered 92.6 mg/kg of biomass.

Over the 2014-2021 period, total AMC in food-producing animals decreased by 44%, while in humans, it remained relatively stable. The consumption of certain antimicrobials was positively associated with resistance to those substances in bacteria from both humans and food-producing animals.

The report also highlighted that E coli resistance is linked in humans to the use of carbapenems, third- and fourth-generation cephalosporins, and quinolones and in food-producing animals to the administration of quinolones, polymyxins, aminopenicillins, and tetracyclines. Further, a connection exists between bacterial resistance in humans and food-producing animals, particularly for bacterial species such as Campylobacter jejuni and C coli.

The findings suggest that measures to reduce AMC in both food-producing animals and humans have been effective in many countries. However, reinforcing these measures is crucial to maintain and further advance reductions in AMC.
 

More Work

Aligned with the European Commission’s One Health holistic and coordinated approach to managing the human and veterinary sectors together, the European agencies advocate for:

  • Sustained efforts to combat AMR at national, EU, and global levels.
  • Coordinated surveillance of antibiotic use and AMR in both human and animal sectors.
  • Continued research in the field of AMR.

The statistical code used to conduct these analyses was made publicly available in order to support further research analyses.
 

A version of this article appeared on Medscape.com.

A decline in antibiotic-resistant bacteria has been observed in European countries that have curbed the use of antibiotics in both animals and humans, revealed the fourth joint interagency antimicrobial consumption and resistance analysis report.

The report was published by the European Centre for Disease Prevention and Control, the European Food Safety Authority, and the European Medicines Agency. Its findings were derived from an integrated analysis of the potential relationship between antimicrobial consumption (AMC) by humans and animals and the occurrence of antimicrobial resistance (AMR) using data collected between 2019 and 2021.
 

A Real Threat

AMR poses a significant threat to public and animal health, causing more than 35,000 deaths annually in the European Union (EU) and the European Economic Area. It also imposes a substantial economic burden on European healthcare systems, amounting to approximately €11.7 billion per year.

To address this challenge, the Council of the European Union recommended concerted and sustained efforts to achieve a 20% reduction in AMC in humans (compared with 2019 levels) and a 50% reduction in food-producing animals (compared with 2018 levels) by 2030. These targets are outlined in the European Commission’s Farm to Fork strategy.
 

It Really Works

Analysis of the trends of AMC and AMR in Escherichia coli from humans and food-producing animals, conducted for the first time, revealed that the susceptibility of E coli to antimicrobials in humans and animals increases with an overall decrease in the consumption of antibiotics.

Concurrent trends in AMC and AMR from 2014 to 2021 were also assessed. AMC in both human and animal sectors, measured in mg/kg of estimated biomass, was compared at country and European levels. In 2021, human AMC totaled 125.0 mg/kg of biomass, while food-producing animals registered 92.6 mg/kg of biomass.

Over the 2014-2021 period, total AMC in food-producing animals decreased by 44%, while in humans, it remained relatively stable. The consumption of certain antimicrobials was positively associated with resistance to those substances in bacteria from both humans and food-producing animals.

The report also highlighted that E coli resistance is linked in humans to the use of carbapenems, third- and fourth-generation cephalosporins, and quinolones and in food-producing animals to the administration of quinolones, polymyxins, aminopenicillins, and tetracyclines. Further, a connection exists between bacterial resistance in humans and food-producing animals, particularly for bacterial species such as Campylobacter jejuni and C coli.

The findings suggest that measures to reduce AMC in both food-producing animals and humans have been effective in many countries. However, reinforcing these measures is crucial to maintain and further advance reductions in AMC.
 

More Work

Aligned with the European Commission’s One Health holistic and coordinated approach to managing the human and veterinary sectors together, the European agencies advocate for:

  • Sustained efforts to combat AMR at national, EU, and global levels.
  • Coordinated surveillance of antibiotic use and AMR in both human and animal sectors.
  • Continued research in the field of AMR.

The statistical code used to conduct these analyses was made publicly available in order to support further research analyses.
 

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A decline in antibiotic-resistant bacteria has been observed in European countries that have curbed the use of antibiotics in both animals and humans</metaDescription> <articlePDF/> <teaserImage/> <teaser>A joint effort by European disease control, food safety, and regulatory groups has reduced antibiotic-resistant bacteria, finds report.</teaser> <title>Curbing Antibiotic Use Works</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>21</term> <term>15</term> <term canonical="true">20</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>317</term> <term canonical="true">315</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Curbing Antibiotic Use Works</title> <deck/> </itemMeta> <itemContent> <p><br/><br/><span class="tag metaDescription">A decline in antibiotic-resistant bacteria has been observed in European countries that have curbed the use of antibiotics in both animals and humans</span>, revealed the fourth joint interagency antimicrobial consumption and resistance <span class="Hyperlink"><a href="https://www.efsa.europa.eu/en/efsajournal/pub/8589">analysis report</a></span>.<br/><br/>The report was published by the European Centre for Disease Prevention and Control, the European Food Safety Authority, and the European Medicines Agency. Its findings were derived from an integrated analysis of the potential relationship between antimicrobial consumption (AMC) by humans and animals and the occurrence of antimicrobial resistance (AMR) using data collected between 2019 and 2021.<br/><br/></p> <h2>A Real Threat</h2> <p>AMR poses a <span class="Hyperlink"><a href="https://www.ecdc.europa.eu/en/news-events/multi-agency-report-highlights-importance-reducing-antibiotic-use#:~:text=It%20is%20estimated%20that%2C%20every,for%20Economic%20Co%2Doperation%20and">significant threat</a></span> to public and animal health, causing more than 35,000 deaths annually in the European Union (EU) and the European Economic Area. It also imposes a substantial economic burden on European healthcare systems, amounting to approximately €11.7 billion per year.<br/><br/>To address this challenge, the Council of the European Union recommended concerted and sustained efforts to achieve a 20% reduction in AMC in humans (compared with 2019 levels) and a 50% reduction in food-producing animals (compared with 2018 levels) by 2030. These targets are outlined in the European Commission’s <span class="Hyperlink"><a href="https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy_en">Farm to Fork strategy</a></span>.<br/><br/></p> <h2>It Really Works</h2> <p>Analysis of the trends of AMC and AMR in <em>Escherichia coli</em> from humans and food-producing animals, conducted for the first time, revealed that the susceptibility of <em>E coli</em> to antimicrobials in humans and animals increases with an overall decrease in the consumption of antibiotics.<br/><br/>Concurrent trends in AMC and AMR from 2014 to 2021 were also assessed. AMC in both human and animal sectors, measured in mg/kg of estimated biomass, was compared at country and European levels. In 2021, human AMC totaled 125.0 mg/kg of biomass, while food-producing animals registered 92.6 mg/kg of biomass.<br/><br/>Over the 2014-2021 period, total AMC in food-producing animals decreased by 44%, while in humans, it remained relatively stable. The consumption of certain antimicrobials was positively associated with resistance to those substances in bacteria from both humans and food-producing animals.<br/><br/>The report also highlighted that <em>E coli</em> resistance is linked in humans to the use of carbapenems, third- and fourth-generation cephalosporins, and quinolones and in food-producing animals to the administration of quinolones, polymyxins, aminopenicillins, and tetracyclines. Further, a connection exists between bacterial resistance in humans and food-producing animals, particularly for bacterial species such as <em>Campylobacter jejuni</em> and <em>C coli</em>.<br/><br/>The findings suggest that measures to reduce AMC in both food-producing animals and humans have been effective in many countries. However, reinforcing these measures is crucial to maintain and further advance reductions in AMC.<br/><br/></p> <h2>More Work</h2> <p>Aligned with the European Commission’s <span class="Hyperlink"><a href="https://health.ec.europa.eu/publications/council-recommendation-stepping-eu-actions-combat-antimicrobial-resistance-one-health-approach_en">One Health</a></span> holistic and coordinated approach to managing the human and veterinary sectors together, the European agencies advocate for:</p> <ul class="body"> <li>Sustained efforts to combat AMR at national, EU, and global levels.</li> <li>Coordinated surveillance of antibiotic use and AMR in both human and animal sectors.</li> <li>Continued research in the field of AMR.</li> </ul> <p>The statistical code used to conduct these analyses was made publicly available in order to support further research analyses.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/curbing-antibiotic-use-works-2024a10003lf?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Europe Needs to Get on Top of Its Measles Outbreak

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“Measles should be a memory, not a present risk,” Quique Bassat, MBBS, PhD, director general of the Barcelona Institute of Global Health, told this news organization.

That is certainly not the case right now in some parts of Europe. The World Health Organization (WHO) says the European Region is experiencing an alarming rise in cases, and urgent action is needed. Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.

“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”
 

Lapses in Vaccinations

The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.

“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”

Reported national coverage with the first dose of measles-containing vaccine in the European Region fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.

“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.
 

Variation Across Europe

The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. Its figures show Kazakhstan had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.

Romania declared a national epidemic in December 2023. Dr. Datta said there have also been outbreaks in Austria and France.

The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, there were 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.

“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”

Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.

She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”

Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”
 

 

 

Vaccine Hesitance

Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.

“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing autism, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”

The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like measles, mumps, and rubella (MMR).

But the MMR vaccine backslide does not only originate in the pandemic.

Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”

It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.

Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”
 

Clinics and Catch-Up Campaigns

Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.

Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.

“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.

“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”

All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.
 

When Will It Get Back to Normal?

“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.

Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”

Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”
 

A version of this article appeared on Medscape.com.

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“Measles should be a memory, not a present risk,” Quique Bassat, MBBS, PhD, director general of the Barcelona Institute of Global Health, told this news organization.

That is certainly not the case right now in some parts of Europe. The World Health Organization (WHO) says the European Region is experiencing an alarming rise in cases, and urgent action is needed. Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.

“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”
 

Lapses in Vaccinations

The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.

“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”

Reported national coverage with the first dose of measles-containing vaccine in the European Region fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.

“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.
 

Variation Across Europe

The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. Its figures show Kazakhstan had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.

Romania declared a national epidemic in December 2023. Dr. Datta said there have also been outbreaks in Austria and France.

The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, there were 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.

“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”

Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.

She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”

Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”
 

 

 

Vaccine Hesitance

Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.

“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing autism, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”

The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like measles, mumps, and rubella (MMR).

But the MMR vaccine backslide does not only originate in the pandemic.

Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”

It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.

Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”
 

Clinics and Catch-Up Campaigns

Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.

Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.

“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.

“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”

All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.
 

When Will It Get Back to Normal?

“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.

Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”

Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”
 

A version of this article appeared on Medscape.com.

“Measles should be a memory, not a present risk,” Quique Bassat, MBBS, PhD, director general of the Barcelona Institute of Global Health, told this news organization.

That is certainly not the case right now in some parts of Europe. The World Health Organization (WHO) says the European Region is experiencing an alarming rise in cases, and urgent action is needed. Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.

“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”
 

Lapses in Vaccinations

The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.

“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”

Reported national coverage with the first dose of measles-containing vaccine in the European Region fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.

“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.
 

Variation Across Europe

The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. Its figures show Kazakhstan had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.

Romania declared a national epidemic in December 2023. Dr. Datta said there have also been outbreaks in Austria and France.

The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, there were 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.

“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”

Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.

She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”

Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”
 

 

 

Vaccine Hesitance

Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.

“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing autism, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”

The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like measles, mumps, and rubella (MMR).

But the MMR vaccine backslide does not only originate in the pandemic.

Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”

It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.

Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”
 

Clinics and Catch-Up Campaigns

Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.

Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.

“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.

“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”

All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.
 

When Will It Get Back to Normal?

“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.

Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”

Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”
 

A version of this article appeared on Medscape.com.

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Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.</span><br/><br/>“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”<br/><br/></p> <h2>Lapses in Vaccinations</h2> <p>The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.<br/><br/>“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”<br/><br/>Reported national coverage with the first dose of measles-containing vaccine <span class="Hyperlink"><a href="https://www.who.int/europe/news/item/14-12-2023-a-30-fold-rise-of-measles-cases-in-2023-in-the-who-european-region-warrants-urgent-action">in the European Region</a></span> fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.<br/><br/>“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.<br/><br/></p> <h2>Variation Across Europe</h2> <p>The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. <span class="Hyperlink"><a href="https://cdn.who.int/media/docs/librariesprovider2/euro-health-topics/vaccines-and-immunization/eur_mr_monthly-_update_en_december-2023.pdf?sfvrsn=699d575a_2&amp;download=true">Its figures</a><a href="https://www.who.int/europe/news/item/23-01-2024-kazakhstan-responds-to-rapid-escalation-of-measles-cases"> show Kazakhstan </a></span>had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.<br/><br/>Romania declared a national epidemic in December 2023. Dr. Datta said <span class="Hyperlink"><a href="https://www.ecdc.europa.eu/sites/default/files/documents/communicable-disease-threats-report-week-49-2023.pdf">there have also been outbreaks</a></span> in Austria and France.<br/><br/>The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, <span class="Hyperlink"><a href="https://www.gov.uk/government/news/latest-measles-statistics-published">there were</a></span> 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.<br/><br/>“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”<br/><br/>Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.<br/><br/>She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”<br/><br/>Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”<br/><br/></p> <h2>Vaccine Hesitance</h2> <p>Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.<br/><br/>“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing <span class="Hyperlink">autism</span>, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”<br/><br/>The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like <span class="Hyperlink">measles, mumps, and rubella</span> (MMR).<br/><br/>But the MMR vaccine backslide does not only originate in the pandemic.<br/><br/>Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”<br/><br/>It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.<br/><br/>Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”<br/><br/></p> <h2>Clinics and Catch-Up Campaigns</h2> <p>Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.<br/><br/>Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.<br/><br/>“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.<br/><br/>“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”<br/><br/>All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.<br/><br/></p> <h2>When Will It Get Back to Normal?</h2> <p>“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.<br/><br/>Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”<br/><br/>Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/europe-needs-get-top-its-measles-outbreak-2024a10002td?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Rubella Screening in Pregnancy No Longer Recommended in Italy

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Fri, 01/26/2024 - 15:03

 

If a pregnant woman contracts rubella in the first 17 weeks of pregnancy, then the risk for congenital rubella in the newborn — which may entail spontaneous abortion, intrauterine death, or severe fetal malformations — is as high as 80%. This risk once frightened patients and clinicians in Italy. Thanks to widespread population vaccination, however, the World Health Organization declared the elimination of endemic transmission of rubella in Italy in 2021. The Italian National Institute of Health took note, and the recent update of the Guidelines for the Management of Physiological Pregnancy no longer recommends offering rubella screening to all pregnant women.

The Rubeo Test

The rubeo test, an analysis for detecting antibodies in the blood produced by vaccination or a past rubella infection, traditionally forms part of the examination package that every doctor prescribes to expectant patients at the beginning of pregnancy. If the test shows that the woman is not vaccinated and has never encountered the virus, making her susceptible to the risk for infection, according to the previous edition of the Guidelines, then the test should be repeated at 17 weeks of gestation. The purpose is to detect any rubella contracted during pregnancy and offer the woman multidisciplinary counseling in the case of a high risk for severe fetal damage. Infection contracted after the 17th week, however, poses only a minimal risk for congenital deafness. There is no treatment to prevent vertical transmission in case of infection during pregnancy.

For women at risk for infection, the old Guidelines also recommended planning vaccination postnatally, with the prospect of protecting future pregnancies. Rubella vaccination is contraindicated during pregnancy because the vaccine could be teratogenic.

Recommendation Update

In the early ‘90s, universal vaccination against rubella for newborns was introduced in Italy. It became one of the 10 mandatory pediatric vaccinations in 2017. In June 2022, the Ministry of Health reported a vaccination coverage of 93.8% among children aged 24 months, a coverage of 93.3% for the first dose, and a coverage of 89.0% for the second dose in the 2003 birth cohort.

“Rubella is a notifiable disease, and in 2013, the newly activated national surveillance system detected one case of congenital rubella per 100,000 newborns. From 2018 onward, no cases have been reported,” said Vittorio Basevi, a gynecologist of the Perinatal Technical-Scientific Advisory Commission in the Emilia Romagna Region and coordinator of the Technical-Scientific Committee that developed the updated Guidelines. “Thanks to extensive vaccination coverage, the infection no longer circulates in Italy. Based on these data, we decided not to offer screening to pregnant women anymore.”

The recommendation to offer rubella vaccination post partum to women without documentation of two doses or previous infection remains confirmed.

Patients Born Abroad 

How should one handle the care of a pregnant woman born in a country where universal rubella vaccination is not provided? The likelihood that she is susceptible to infection is higher than the that of the general Italian population. “On the other hand, since the virus no longer circulates in our country, the probability of contracting the virus during pregnancy is negligible, unless she has recently traveled to her country of origin or come into contact with family members who recently arrived in Italy,” said Dr. Basevi. “The Guidelines refer to offering screening to all pregnant women. In specific cases, it is up to the treating physician to adopt the conduct they deem appropriate in science and conscience.”

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

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If a pregnant woman contracts rubella in the first 17 weeks of pregnancy, then the risk for congenital rubella in the newborn — which may entail spontaneous abortion, intrauterine death, or severe fetal malformations — is as high as 80%. This risk once frightened patients and clinicians in Italy. Thanks to widespread population vaccination, however, the World Health Organization declared the elimination of endemic transmission of rubella in Italy in 2021. The Italian National Institute of Health took note, and the recent update of the Guidelines for the Management of Physiological Pregnancy no longer recommends offering rubella screening to all pregnant women.

The Rubeo Test

The rubeo test, an analysis for detecting antibodies in the blood produced by vaccination or a past rubella infection, traditionally forms part of the examination package that every doctor prescribes to expectant patients at the beginning of pregnancy. If the test shows that the woman is not vaccinated and has never encountered the virus, making her susceptible to the risk for infection, according to the previous edition of the Guidelines, then the test should be repeated at 17 weeks of gestation. The purpose is to detect any rubella contracted during pregnancy and offer the woman multidisciplinary counseling in the case of a high risk for severe fetal damage. Infection contracted after the 17th week, however, poses only a minimal risk for congenital deafness. There is no treatment to prevent vertical transmission in case of infection during pregnancy.

For women at risk for infection, the old Guidelines also recommended planning vaccination postnatally, with the prospect of protecting future pregnancies. Rubella vaccination is contraindicated during pregnancy because the vaccine could be teratogenic.

Recommendation Update

In the early ‘90s, universal vaccination against rubella for newborns was introduced in Italy. It became one of the 10 mandatory pediatric vaccinations in 2017. In June 2022, the Ministry of Health reported a vaccination coverage of 93.8% among children aged 24 months, a coverage of 93.3% for the first dose, and a coverage of 89.0% for the second dose in the 2003 birth cohort.

“Rubella is a notifiable disease, and in 2013, the newly activated national surveillance system detected one case of congenital rubella per 100,000 newborns. From 2018 onward, no cases have been reported,” said Vittorio Basevi, a gynecologist of the Perinatal Technical-Scientific Advisory Commission in the Emilia Romagna Region and coordinator of the Technical-Scientific Committee that developed the updated Guidelines. “Thanks to extensive vaccination coverage, the infection no longer circulates in Italy. Based on these data, we decided not to offer screening to pregnant women anymore.”

The recommendation to offer rubella vaccination post partum to women without documentation of two doses or previous infection remains confirmed.

Patients Born Abroad 

How should one handle the care of a pregnant woman born in a country where universal rubella vaccination is not provided? The likelihood that she is susceptible to infection is higher than the that of the general Italian population. “On the other hand, since the virus no longer circulates in our country, the probability of contracting the virus during pregnancy is negligible, unless she has recently traveled to her country of origin or come into contact with family members who recently arrived in Italy,” said Dr. Basevi. “The Guidelines refer to offering screening to all pregnant women. In specific cases, it is up to the treating physician to adopt the conduct they deem appropriate in science and conscience.”

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

 

If a pregnant woman contracts rubella in the first 17 weeks of pregnancy, then the risk for congenital rubella in the newborn — which may entail spontaneous abortion, intrauterine death, or severe fetal malformations — is as high as 80%. This risk once frightened patients and clinicians in Italy. Thanks to widespread population vaccination, however, the World Health Organization declared the elimination of endemic transmission of rubella in Italy in 2021. The Italian National Institute of Health took note, and the recent update of the Guidelines for the Management of Physiological Pregnancy no longer recommends offering rubella screening to all pregnant women.

The Rubeo Test

The rubeo test, an analysis for detecting antibodies in the blood produced by vaccination or a past rubella infection, traditionally forms part of the examination package that every doctor prescribes to expectant patients at the beginning of pregnancy. If the test shows that the woman is not vaccinated and has never encountered the virus, making her susceptible to the risk for infection, according to the previous edition of the Guidelines, then the test should be repeated at 17 weeks of gestation. The purpose is to detect any rubella contracted during pregnancy and offer the woman multidisciplinary counseling in the case of a high risk for severe fetal damage. Infection contracted after the 17th week, however, poses only a minimal risk for congenital deafness. There is no treatment to prevent vertical transmission in case of infection during pregnancy.

For women at risk for infection, the old Guidelines also recommended planning vaccination postnatally, with the prospect of protecting future pregnancies. Rubella vaccination is contraindicated during pregnancy because the vaccine could be teratogenic.

Recommendation Update

In the early ‘90s, universal vaccination against rubella for newborns was introduced in Italy. It became one of the 10 mandatory pediatric vaccinations in 2017. In June 2022, the Ministry of Health reported a vaccination coverage of 93.8% among children aged 24 months, a coverage of 93.3% for the first dose, and a coverage of 89.0% for the second dose in the 2003 birth cohort.

“Rubella is a notifiable disease, and in 2013, the newly activated national surveillance system detected one case of congenital rubella per 100,000 newborns. From 2018 onward, no cases have been reported,” said Vittorio Basevi, a gynecologist of the Perinatal Technical-Scientific Advisory Commission in the Emilia Romagna Region and coordinator of the Technical-Scientific Committee that developed the updated Guidelines. “Thanks to extensive vaccination coverage, the infection no longer circulates in Italy. Based on these data, we decided not to offer screening to pregnant women anymore.”

The recommendation to offer rubella vaccination post partum to women without documentation of two doses or previous infection remains confirmed.

Patients Born Abroad 

How should one handle the care of a pregnant woman born in a country where universal rubella vaccination is not provided? The likelihood that she is susceptible to infection is higher than the that of the general Italian population. “On the other hand, since the virus no longer circulates in our country, the probability of contracting the virus during pregnancy is negligible, unless she has recently traveled to her country of origin or come into contact with family members who recently arrived in Italy,” said Dr. Basevi. “The Guidelines refer to offering screening to all pregnant women. In specific cases, it is up to the treating physician to adopt the conduct they deem appropriate in science and conscience.”

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>If a pregnant woman contracts rubella in the first 17 weeks of pregnancy, then the risk for congenital rubella in the newborn — which may entail spontaneous abo</metaDescription> <articlePDF/> <teaserImage/> <teaser>The elimination of the endemic transmission of rubella in Italy prompted a reconsideration of the country’s pregnancy guidelines.</teaser> <title>Rubella Screening in Pregnancy No Longer Recommended in Italy</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>mdid</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">23</term> <term>15</term> <term>51892</term> <term>25</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>280</term> <term canonical="true">262</term> <term>322</term> <term>317</term> <term>311</term> <term>254</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Rubella Screening in Pregnancy No Longer Recommended in Italy</title> <deck/> </itemMeta> <itemContent> <p>If a pregnant woman contracts <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/968523-overview">rubella</a></span> in the first 17 weeks of pregnancy, then the risk for congenital rubella in the newborn — which may entail <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/795085-overview">spontaneous abortion</a></span>, intrauterine death, or severe fetal malformations — is as high as 80%. This risk once frightened patients and clinicians in Italy. Thanks to widespread population vaccination, however, the World Health Organization declared the elimination of endemic transmission of rubella in Italy in 2021. The Italian National Institute of Health took note, and the recent update of the Guidelines for the Management of Physiological Pregnancy no longer recommends offering rubella screening to all pregnant women.</p> <h2>The Rubeo Test</h2> <p>The rubeo test, an analysis for detecting antibodies in the blood produced by vaccination or a past rubella infection, traditionally forms part of the examination package that every doctor prescribes to expectant patients at the beginning of pregnancy. If the test shows that the woman is not vaccinated and has never encountered the virus, making her susceptible to the risk for infection, according to the previous edition of the Guidelines, then the test should be repeated at 17 weeks of gestation. The purpose is to detect any rubella contracted during pregnancy and offer the woman multidisciplinary counseling in the case of a high risk for severe fetal damage. Infection contracted after the 17th week, however, poses only a minimal risk for congenital deafness. There is no treatment to prevent vertical transmission in case of infection during pregnancy.</p> <p>For women at risk for infection, the old Guidelines also recommended planning vaccination postnatally, with the prospect of protecting future pregnancies. Rubella vaccination is contraindicated during pregnancy because the vaccine could be teratogenic.</p> <h2>Recommendation Update</h2> <p>In the early ‘90s, universal vaccination against rubella for newborns was introduced in Italy. It became one of the 10 mandatory pediatric vaccinations in 2017. In June 2022, the Ministry of Health reported a vaccination coverage of 93.8% among children aged 24 months, a coverage of 93.3% for the first dose, and a coverage of 89.0% for the second dose in the 2003 birth cohort.</p> <p>“Rubella is a notifiable disease, and in 2013, the newly activated national surveillance system detected one case of congenital rubella per 100,000 newborns. From 2018 onward, no cases have been reported,” said Vittorio Basevi, a gynecologist of the Perinatal Technical-Scientific Advisory Commission in the Emilia Romagna Region and coordinator of the Technical-Scientific Committee that developed the updated Guidelines. “Thanks to extensive vaccination coverage, the infection no longer circulates in Italy. Based on these data, we decided not to offer screening to pregnant women anymore.”<br/><br/>The recommendation to offer rubella vaccination post partum to women without documentation of two doses or previous infection remains confirmed.</p> <h2>Patients Born Abroad </h2> <p>How should one handle the care of a pregnant woman born in a country where universal rubella vaccination is not provided? The likelihood that she is susceptible to infection is higher than the that of the general Italian population. “On the other hand, since the virus no longer circulates in our country, the probability of contracting the virus during pregnancy is negligible, unless she has recently traveled to her country of origin or come into contact with family members who recently arrived in Italy,” said Dr. Basevi. “The Guidelines refer to offering screening to all pregnant women. In specific cases, it is up to the treating physician to adopt the conduct they deem appropriate in science and conscience.”<span class="end"/></p> <p> <em>This article was translated from <span class="Hyperlink"><a href="https://www.univadis.it/viewarticle/non-%25C3%25A8-pi%25C3%25B9-raccomandato-screening-rosolia-2024a10000yy">Univadis Italy</a></span>, which is part of the Medscape Professional Network. A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/rubella-screening-pregnancy-no-longer-recommended-italy-2024a10001qt?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Malaria is spreading in the U.S. for the first time in 20 years

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Thu, 07/06/2023 - 10:34

The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas, the Centers for Disease Control and Prevention says. 

The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.

All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.

Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.

The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.

The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.

More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.

A version of this article first appeared on WebMD.com.

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The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas, the Centers for Disease Control and Prevention says. 

The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.

All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.

Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.

The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.

The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.

More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.

A version of this article first appeared on WebMD.com.

The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas, the Centers for Disease Control and Prevention says. 

The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.

All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.

Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.

The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.

The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.

More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.

A version of this article first appeared on WebMD.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas</metaDescription> <articlePDF/> <teaserImage/> <teaser>The CDC said the risk of getting malaria while in the United States “remains extremely low.”</teaser> <title>Malaria is spreading in the U.S. for the first time in 20 years</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">20</term> <term>15</term> <term>21</term> <term>25</term> </publications> <sections> <term>39313</term> <term canonical="true">27979</term> </sections> <topics> <term canonical="true">317</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Malaria is spreading in the U.S. for the first time in 20 years</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas</span>, the Centers for Disease Control and Prevention says. </p> <p>The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.<br/><br/>All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.<br/><br/>Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The <a href="https://www.dshs.texas.gov/news-alerts/health-advisory-locally-acquired-malaria-case">Texas Department of State Health Services</a> said the last time malaria was locally acquired in the state was 1994.<br/><br/>The <a href="https://www.floridahealth.gov/diseases-and-conditions/mosquito-borne-diseases/_documents/alert-sarasota-manatee-6-19-2023.pdf">Florida Department of Health</a> said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.<br/><br/>The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.<br/><br/>More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.webmd.com/a-to-z-guides/news/20230627/malaria-is-spreading-in-the-us-first-time-20-years">WebMD.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Mpox: Dermatology registry data pinpoints unique signs

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Tue, 01/24/2023 - 14:07

Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions that frequently appeared before systemic illness and a much lower overall numbers of lesions.

“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” Esther Freeman, MD, PhD, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the Journal of the American Academy of Dermatology.

Monkeypox_NIAID_web.jpg

“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”

According to the Centers for Disease Control and Prevention, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.

Freeman_Esther_Mass_web.jpg
Dr. Esther Freeman


Most of the affected cases were among gay, bisexual, and other men who have sex with men. A vaccination effort began last summer, and the number of cases soon plummeted. The national daily case count in January has been in the single digits.

For the new report, dermatologists tracked cases via the American Academy of Dermatology/International League of Dermatologic Societies (AAD/ILDS) Dermatology COVID-19, Monkeypox (mpox), and Emerging Infections Registry. The new report includes data about cases entered from Aug. 4 to Nov. 13. Of these cases, 97% were male, median age was 35 years, 62% were White, 20% were Hispanic, and 11% were Black.

Just over half (54%) of patients reported skin lesions as the first sign of disease, while others had signs such as fever (16%) and malaise (9%). “This is a sharp contrast to endemic or prior outbreaks in which a ‘flu-like’ prodrome preceded lesions,” Dr. Freeman said. “Dermatologists should be aware that patients may come in with mpox skin lesions as their only initial symptoms.”

[embed:render:related:node:257081]

In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said.

According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”

She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”

 

 

 

Morbilliform rash, scarring reported

The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor Misha Rosenbach, MD, of the University of Pennsylvania, Philadelphia, said in an interview.

Rosenbach_Misha_PHILA_web.jpg
Dr. Misha Rosenbach

“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.”

Emory University dermatologist Howa Yeung, MD, MSc, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”

Yeung_Howa_Georgia_web.jpg
Dr. Howa Yeung


In the report, 13% of patients had scarring, “an outcome underemphasized in the current literature” that could have long-term emotional and mental effects, the authors noted. “Some patients, particularly immunosuppressed patients, have had very large and/or ulceronecrotic lesions,” Dr. Rosenbach said. “Their scarring can be quite significant. There is, to date, very little guidance for clinicians or patients on how to mitigate this risk and, if scarring is developing, how best to manage it.”

As for lessons from the findings, Dr. Yeung said, “dermatologists need to be aware that patients with mpox can have multiple morphologies at the same time and lesions can skip stages.” And, he pointed out, it’s clear that wound care is important to prevent scarring.

The AAD has a resource page on skin care in patients with mpox that includes information about preventing scarring. Examples of mpox rashes are available on the CDC website.

The study was supported by a grant from the International League of Dermatologic Societies and in-kind support from the American Academy of Dermatology. Dr. Freeman is a coauthor for UpToDate. Dr. Freeman and Dr. Rosenbach are members of the AAD Ad Hoc Task Force to Create Monkeypox Content. Study authors reported no other disclosures, and Dr. Yeung has no disclosures.

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Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions that frequently appeared before systemic illness and a much lower overall numbers of lesions.

“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” Esther Freeman, MD, PhD, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the Journal of the American Academy of Dermatology.

Monkeypox_NIAID_web.jpg

“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”

According to the Centers for Disease Control and Prevention, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.

Freeman_Esther_Mass_web.jpg
Dr. Esther Freeman


Most of the affected cases were among gay, bisexual, and other men who have sex with men. A vaccination effort began last summer, and the number of cases soon plummeted. The national daily case count in January has been in the single digits.

For the new report, dermatologists tracked cases via the American Academy of Dermatology/International League of Dermatologic Societies (AAD/ILDS) Dermatology COVID-19, Monkeypox (mpox), and Emerging Infections Registry. The new report includes data about cases entered from Aug. 4 to Nov. 13. Of these cases, 97% were male, median age was 35 years, 62% were White, 20% were Hispanic, and 11% were Black.

Just over half (54%) of patients reported skin lesions as the first sign of disease, while others had signs such as fever (16%) and malaise (9%). “This is a sharp contrast to endemic or prior outbreaks in which a ‘flu-like’ prodrome preceded lesions,” Dr. Freeman said. “Dermatologists should be aware that patients may come in with mpox skin lesions as their only initial symptoms.”

[embed:render:related:node:257081]

In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said.

According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”

She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”

 

 

 

Morbilliform rash, scarring reported

The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor Misha Rosenbach, MD, of the University of Pennsylvania, Philadelphia, said in an interview.

Rosenbach_Misha_PHILA_web.jpg
Dr. Misha Rosenbach

“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.”

Emory University dermatologist Howa Yeung, MD, MSc, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”

Yeung_Howa_Georgia_web.jpg
Dr. Howa Yeung


In the report, 13% of patients had scarring, “an outcome underemphasized in the current literature” that could have long-term emotional and mental effects, the authors noted. “Some patients, particularly immunosuppressed patients, have had very large and/or ulceronecrotic lesions,” Dr. Rosenbach said. “Their scarring can be quite significant. There is, to date, very little guidance for clinicians or patients on how to mitigate this risk and, if scarring is developing, how best to manage it.”

As for lessons from the findings, Dr. Yeung said, “dermatologists need to be aware that patients with mpox can have multiple morphologies at the same time and lesions can skip stages.” And, he pointed out, it’s clear that wound care is important to prevent scarring.

The AAD has a resource page on skin care in patients with mpox that includes information about preventing scarring. Examples of mpox rashes are available on the CDC website.

The study was supported by a grant from the International League of Dermatologic Societies and in-kind support from the American Academy of Dermatology. Dr. Freeman is a coauthor for UpToDate. Dr. Freeman and Dr. Rosenbach are members of the AAD Ad Hoc Task Force to Create Monkeypox Content. Study authors reported no other disclosures, and Dr. Yeung has no disclosures.

Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions that frequently appeared before systemic illness and a much lower overall numbers of lesions.

“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” Esther Freeman, MD, PhD, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the Journal of the American Academy of Dermatology.

Monkeypox_NIAID_web.jpg

“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”

According to the Centers for Disease Control and Prevention, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.

Freeman_Esther_Mass_web.jpg
Dr. Esther Freeman


Most of the affected cases were among gay, bisexual, and other men who have sex with men. A vaccination effort began last summer, and the number of cases soon plummeted. The national daily case count in January has been in the single digits.

For the new report, dermatologists tracked cases via the American Academy of Dermatology/International League of Dermatologic Societies (AAD/ILDS) Dermatology COVID-19, Monkeypox (mpox), and Emerging Infections Registry. The new report includes data about cases entered from Aug. 4 to Nov. 13. Of these cases, 97% were male, median age was 35 years, 62% were White, 20% were Hispanic, and 11% were Black.

Just over half (54%) of patients reported skin lesions as the first sign of disease, while others had signs such as fever (16%) and malaise (9%). “This is a sharp contrast to endemic or prior outbreaks in which a ‘flu-like’ prodrome preceded lesions,” Dr. Freeman said. “Dermatologists should be aware that patients may come in with mpox skin lesions as their only initial symptoms.”

[embed:render:related:node:257081]

In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said.

According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”

She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”

 

 

 

Morbilliform rash, scarring reported

The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor Misha Rosenbach, MD, of the University of Pennsylvania, Philadelphia, said in an interview.

Rosenbach_Misha_PHILA_web.jpg
Dr. Misha Rosenbach

“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.”

Emory University dermatologist Howa Yeung, MD, MSc, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”

Yeung_Howa_Georgia_web.jpg
Dr. Howa Yeung


In the report, 13% of patients had scarring, “an outcome underemphasized in the current literature” that could have long-term emotional and mental effects, the authors noted. “Some patients, particularly immunosuppressed patients, have had very large and/or ulceronecrotic lesions,” Dr. Rosenbach said. “Their scarring can be quite significant. There is, to date, very little guidance for clinicians or patients on how to mitigate this risk and, if scarring is developing, how best to manage it.”

As for lessons from the findings, Dr. Yeung said, “dermatologists need to be aware that patients with mpox can have multiple morphologies at the same time and lesions can skip stages.” And, he pointed out, it’s clear that wound care is important to prevent scarring.

The AAD has a resource page on skin care in patients with mpox that includes information about preventing scarring. Examples of mpox rashes are available on the CDC website.

The study was supported by a grant from the International League of Dermatologic Societies and in-kind support from the American Academy of Dermatology. Dr. Freeman is a coauthor for UpToDate. Dr. Freeman and Dr. Rosenbach are members of the AAD Ad Hoc Task Force to Create Monkeypox Content. Study authors reported no other disclosures, and Dr. Yeung has no disclosures.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin l</metaDescription> <articlePDF/> <teaserImage>288358</teaserImage> <title>Mpox: Dermatology registry data pinpoints unique signs</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> <term>27970</term> </sections> <topics> <term canonical="true">234</term> <term>203</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24010fff.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">NIAID</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24010dd7.jpg</altRep> <description role="drol:caption">Dr. Esther Freeman</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24010754.jpg</altRep> <description role="drol:caption">Dr. Misha Rosenbach</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/2400f77a.jpg</altRep> <description role="drol:caption">Dr. Howa Yeung</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Mpox: Dermatology registry data pinpoints unique signs</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions</span> that frequently appeared before systemic illness and a much lower overall numbers of lesions. </p> <p>“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” <span class="Hyperlink"><a href="https://www.massgeneral.org/doctors/19521/esther-freeman">Esther Freeman, MD, PhD</a></span>, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the <span class="Hyperlink"><a href="https://www.jaad.org/article/S0190-9622(23)00057-9/pdf">Journal of the American Academy of Dermatology</a></span>.<br/><br/>[[{"fid":"288358","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Colorized transmission electron micrograph of monkeypox particles (pink) found within an infected cell (green), cultured in the laboratory. Image captured and color-enhanced.","field_file_image_credit[und][0][value]":"NIAID","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”<br/><br/>According to the <span class="Hyperlink"><a href="https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html">Centers for Disease Control and Prevention</a></span>, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.[[{"fid":"287066","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Esther Freeman, MD, PhD, Director, Global Health Dermatology, Massachusetts General Hospital, Boston, and associate professor of dermatology, Harvard Medical School, Boston","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Esther Freeman"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>Most of the affected cases were among gay, bisexual, and other men who have sex with men. A vaccination effort began last summer, and the number of cases soon plummeted. The national <span class="Hyperlink"><a href="https://www.cdc.gov/poxvirus/monkeypox/response/2022/mpx-trends.html">daily case count in January</a></span> has been in the single digits. <br/><br/>For the new report, dermatologists tracked cases via the American Academy of Dermatology/International League of Dermatologic Societies (AAD/ILDS) <span class="Hyperlink"><a href="https://redcap.partners.org/redcap/surveys/index.php?s=YJWAJCX7TY">Dermatology COVID-19, Monkeypox (mpox), and Emerging Infections Registry</a></span>. The new report includes data about cases entered from Aug. 4 to Nov. 13. Of these cases, 97% were male, median age was 35 years, 62% were White, 20% were Hispanic, and 11% were Black. <br/><br/>Just over half (54%) of patients reported skin lesions as the first sign of disease, while others had signs such as fever (16%) and malaise (9%). “This is a sharp contrast to endemic or prior outbreaks in which a ‘flu-like’ prodrome preceded lesions,” Dr. Freeman said. “Dermatologists should be aware that patients may come in with mpox skin lesions as their only initial symptoms.”<br/><br/>In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said. <br/><br/>According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”<br/><br/>She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”<br/><br/><br/><br/></p> <h2>Morbilliform rash, scarring reported</h2> <p>The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor <span class="Hyperlink"><a href="https://www.pennmedicine.org/providers/profile/misha-rosenbach">Misha Rosenbach, MD</a></span>, of the University of Pennsylvania, Philadelphia, said in an interview. [[{"fid":"283975","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Misha Rosenbach, department of dermatology, University of Pennsylvania, Philadelphia.","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Misha Rosenbach"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.” </p> <p>Emory University dermatologist <span class="Hyperlink"><a href="https://providers.emoryhealthcare.org/provider/Howa+Yeung/777669">Howa Yeung, MD, MSc</a></span>, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”[[{"fid":"274706","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Howa Yeung, MD, department of dermatology, Emory University, Atlanta","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Howa Yeung"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]<br/><br/>In the report, 13% of patients had scarring, “an outcome underemphasized in the current literature” that could have long-term emotional and mental effects, the authors noted. “Some patients, particularly immunosuppressed patients, have had very large and/or ulceronecrotic lesions,” Dr. Rosenbach said. “Their scarring can be quite significant. There is, to date, very little guidance for clinicians or patients on how to mitigate this risk and, if scarring is developing, how best to manage it.”<br/><br/>As for lessons from the findings, Dr. Yeung said, “dermatologists need to be aware that patients with mpox can have multiple morphologies at the same time and lesions can skip stages.” And, he pointed out, it’s clear that wound care is important to prevent scarring.<br/><br/>The AAD has a <span class="Hyperlink"><a href="https://www.aad.org/member/clinical-quality/clinical-care/monkeypox/treatment">resource page</a></span> on skin care in patients with mpox that includes information about preventing scarring. Examples of mpox rashes are available on the <span class="Hyperlink"><a href="https://www.cdc.gov/poxvirus/monkeypox/clinicians/clinical-recognition.html">CDC website</a></span>. <br/><br/>The study was supported by a grant from the International League of Dermatologic Societies and in-kind support from the American Academy of Dermatology. Dr. Freeman is a coauthor for UpToDate. Dr. Freeman and Dr. Rosenbach are members of the AAD Ad Hoc Task Force to Create Monkeypox Content. Study authors reported no other disclosures, and Dr. Yeung has no disclosures. </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>Skin lesions are more likely to precede systemic illness, and overall lesion numbers are lower.</p> </itemContent> </newsItem> </itemSet></root>
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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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Systematic review supports preferred drugs for HIV in youths

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Fri, 12/23/2022 - 10:07

A systematic review of observational studies and clinical trials found dolutegravir and raltegravir to be safe and effective for treating teens and children living with HIV.

Effectiveness was higher across dolutegravir studies, the authors reported. After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.

“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”

The study was published in the Journal of the International AIDS Society.
 

Tracking outcomes for WHO guidelines

Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.

Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.

Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.

Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.

The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.

Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.

However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”

The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.

“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services & Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.

Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.

Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.

A version of this article first appeared on Medscape.com.

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A systematic review of observational studies and clinical trials found dolutegravir and raltegravir to be safe and effective for treating teens and children living with HIV.

Effectiveness was higher across dolutegravir studies, the authors reported. After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.

“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”

The study was published in the Journal of the International AIDS Society.
 

Tracking outcomes for WHO guidelines

Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.

Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.

Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.

Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.

The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.

Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.

However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”

The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.

“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services & Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.

Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.

Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.

A version of this article first appeared on Medscape.com.

A systematic review of observational studies and clinical trials found dolutegravir and raltegravir to be safe and effective for treating teens and children living with HIV.

Effectiveness was higher across dolutegravir studies, the authors reported. After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.

“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”

The study was published in the Journal of the International AIDS Society.
 

Tracking outcomes for WHO guidelines

Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.

Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.

Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.

Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.

The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.

Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.

However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”

The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.

“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services & Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.

Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.

Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.

A version of this article first appeared on Medscape.com.

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After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.<br/><br/>“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”<br/><br/>The study was <a href="https://doi.org/10.1002/jia2.25970">published</a> in the Journal of the International AIDS Society.<br/><br/></p> <h2>Tracking outcomes for WHO guidelines</h2> <p>Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.</p> <p>Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.<br/><br/>Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.<br/><br/>Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.<br/><br/>The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.<br/><br/>Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.<br/><br/>However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”<br/><br/>The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.<br/><br/>“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services &amp; Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.<br/><br/>Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.<br/><br/>Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/985800">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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FROM THE JOURNAL OF THE INTERNATIONAL AIDS SOCIETY

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