Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

Françoise Renaud; Lynne M. Mofenson; Charlotte Bakker; Helen Dolk; Valeriane Leroy; Angelina Namiba; Leyla Sahin; Roger Shapiro; Amy Slogrove; Claire Thorne; Marissa Vicari; Daniel Low‐Beer; Meg Doherty

doi:10.1002/jia2.25922

Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

Françoise Renaud, Lynne M. Mofenson, Charlotte Bakker, Helen Dolk, Valeriane Leroy, Angelina Namiba, Leyla Sahin, Roger Shapiro, Amy Slogrove, Claire Thorne, Marissa Vicari, Daniel Low‐Beer, Meg Doherty

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Abstract

IntroductionAs new antiretrovirals (ARVs), including long-acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization.DiscussionThis paper highlights that although robust sources of safety data and surveillance programs exist, key challenges remain, including unknown denominators, reporting bias, under-reporting (e.g. in voluntary registries), few data sources from resource-limited settings (most are in North America and Europe), incomplete or inaccurate data (e.g. within routine medical records). However, recent experiences (e.g. with safety signals) and current innovations (e.g. electronic record use in resource-limited settings and defining adverse outcomes) provide momentum and building blocks for a new framework for active surveillance of ARV safety in pregnancy. A public health approach should be taken using data from existing sources, including registries of pregnancy ARV exposure and birth defects; observational surveillance and cohort studies; clinical trials; and real-world databases. Key facilitators are harmonization and standardization of outcomes, sharing of materials and tools, and data linkages between programs. Other key facilitators include the development of guidance to estimate sample size and duration of surveillance, ensuring strategic geographic diversity, bringing partners together to share information and engaging the community of women living with HIV.ConclusionsLooking ahead, critical steps to safely introduce new ARVs include (1) adopting harmonized standards for measuring adverse maternal, birth and infant outcomes; (2) establishing surveillance centres of excellence in areas with high HIV prevalence with harmonized data collection and optimized electronic health records linking maternal/infant data; and (3) creating targets and evaluation goals for reporting progress on implementation and quality of surveillance in pregnancy. The platform will be leveraged to ensure that appropriate contributions and strategic actions by relevant stakeholders are implemented.

Original language	English
Article number	e25922
Pages (from-to)	1-6
Number of pages	6
Journal	Journal of the International AIDS Society
Volume	25
Issue number	S2
Early online date	19 Jul 2022
DOIs	https://doi.org/10.1002/jia2.25922
Publication status	Published (in print/issue) - 19 Jul 2022

Bibliographical note

Funding Information:
LM has received funding from World Health Organization as consultant on antiretroviral drugs in pregnancy; Elisabeth Glazer Pediatric AIDS Foundation is receiving research funding from ViiV for a pilot birth surveillance program in Eswatini. MV reported that CIPHER is funded by grants from ViiV Healthcare, Janssen, Viatris and Merck. CT has received grant funding from ViiV Healthcare (via Penta Foundation). Other authors did not report competing interests.

Funding Information:
Recent years have seen the emergence of electronic health‐related data systems in a number of HIV high prevalence countries that can assist surveillance efforts. Perhaps the most mature is in the Western Cape Province of South Africa, where approximately 15 years ago the provincial government invested in unique patient identifiers used across all public‐sector health services. With the support of research and other partners, the Western Cape Provincial Health Data Centre integrates multiple electronic sources of data at an individual level to identify healthcare system encounters as well as disease episodes, such as pregnancy or HIV [ 31, 32 ]. Through the US NIH‐funded International Epidemiology Database to Evaluate AIDS (IeDEA) consortium and funding from the Gates Foundation, pilot sentinel birth outcomes surveillance has been set up in the Western Cape (Western Cape Pregnancy Exposure Registry) and at the Moi Teaching and Referral Hospital in western Kenya.

Funding Information:
We gratefully acknowledge Olubukola Ayinde, Nahida Chakhtoura, Michelle Chevalier, Karen Cohen, Corinne de Vries, Patrick Jean-Philippe, Corinne Merle, Nyaradso Mgodi, Mark Mirochnick, Phillipa Musoke, Pamela Nawaggi, Anton Pozniak and Marie-Eve Raguenaud for their contributions as members of the IMPAACT Network and World Health Organization Virtual Workshop on Approaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections in Pregnant Women and the working group on surveillance.

Publisher Copyright:
© 2022 World Health Organization; licensed by IAS.

Funding

Funding Information: LM has received funding from World Health Organization as consultant on antiretroviral drugs in pregnancy; Elisabeth Glazer Pediatric AIDS Foundation is receiving research funding from ViiV for a pilot birth surveillance program in Eswatini. MV reported that CIPHER is funded by grants from ViiV Healthcare, Janssen, Viatris and Merck. CT has received grant funding from ViiV Healthcare (via Penta Foundation). Other authors did not report competing interests. Funding Information: Recent years have seen the emergence of electronic health‐related data systems in a number of HIV high prevalence countries that can assist surveillance efforts. Perhaps the most mature is in the Western Cape Province of South Africa, where approximately 15 years ago the provincial government invested in unique patient identifiers used across all public‐sector health services. With the support of research and other partners, the Western Cape Provincial Health Data Centre integrates multiple electronic sources of data at an individual level to identify healthcare system encounters as well as disease episodes, such as pregnancy or HIV [ 31, 32 ]. Through the US NIH‐funded International Epidemiology Database to Evaluate AIDS (IeDEA) consortium and funding from the Gates Foundation, pilot sentinel birth outcomes surveillance has been set up in the Western Cape (Western Cape Pregnancy Exposure Registry) and at the Moi Teaching and Referral Hospital in western Kenya. Funding Information: We gratefully acknowledge Olubukola Ayinde, Nahida Chakhtoura, Michelle Chevalier, Karen Cohen, Corinne de Vries, Patrick Jean-Philippe, Corinne Merle, Nyaradso Mgodi, Mark Mirochnick, Phillipa Musoke, Pamela Nawaggi, Anton Pozniak and Marie-Eve Raguenaud for their contributions as members of the IMPAACT Network and World Health Organization Virtual Workshop on Approaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections in Pregnant Women and the working group on surveillance. Publisher Copyright: © 2022 World Health Organization; licensed by IAS.

Keywords

Supplement: Commentary
Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy. Guest Editors: Elaine J. Abrams, Martina Penazzato
HIV
antiretrovirals
pregnancy
safety
adverse pregnancy outcomes
surveillance
Europe
Humans
Breast Feeding
HIV Infections - drug therapy - epidemiology - prevention & control
Infant
North America
Pregnancy
Anti-Retroviral Agents - adverse effects - therapeutic use
Adolescent
Female
Child
Cohort Studies

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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jia2.25922.pdfFinal published version, 423 KBLicence: CC BY

Cite this

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title = "Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework",

abstract = "IntroductionAs new antiretrovirals (ARVs), including long-acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization.DiscussionThis paper highlights that although robust sources of safety data and surveillance programs exist, key challenges remain, including unknown denominators, reporting bias, under-reporting (e.g. in voluntary registries), few data sources from resource-limited settings (most are in North America and Europe), incomplete or inaccurate data (e.g. within routine medical records). However, recent experiences (e.g. with safety signals) and current innovations (e.g. electronic record use in resource-limited settings and defining adverse outcomes) provide momentum and building blocks for a new framework for active surveillance of ARV safety in pregnancy. A public health approach should be taken using data from existing sources, including registries of pregnancy ARV exposure and birth defects; observational surveillance and cohort studies; clinical trials; and real-world databases. Key facilitators are harmonization and standardization of outcomes, sharing of materials and tools, and data linkages between programs. Other key facilitators include the development of guidance to estimate sample size and duration of surveillance, ensuring strategic geographic diversity, bringing partners together to share information and engaging the community of women living with HIV.ConclusionsLooking ahead, critical steps to safely introduce new ARVs include (1) adopting harmonized standards for measuring adverse maternal, birth and infant outcomes; (2) establishing surveillance centres of excellence in areas with high HIV prevalence with harmonized data collection and optimized electronic health records linking maternal/infant data; and (3) creating targets and evaluation goals for reporting progress on implementation and quality of surveillance in pregnancy. The platform will be leveraged to ensure that appropriate contributions and strategic actions by relevant stakeholders are implemented.",

keywords = "Supplement: Commentary, Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy. Guest Editors: Elaine J. Abrams, Martina Penazzato, HIV, antiretrovirals, pregnancy, safety, adverse pregnancy outcomes, surveillance, Europe, Humans, Breast Feeding, HIV Infections - drug therapy - epidemiology - prevention \& control, Infant, North America, Pregnancy, Anti-Retroviral Agents - adverse effects - therapeutic use, Adolescent, Female, Child, Cohort Studies",

author = "Fran{\c c}oise Renaud and Mofenson, \{Lynne M.\} and Charlotte Bakker and Helen Dolk and Valeriane Leroy and Angelina Namiba and Leyla Sahin and Roger Shapiro and Amy Slogrove and Claire Thorne and Marissa Vicari and Daniel Low‐Beer and Meg Doherty",

note = "Funding Information: LM has received funding from World Health Organization as consultant on antiretroviral drugs in pregnancy; Elisabeth Glazer Pediatric AIDS Foundation is receiving research funding from ViiV for a pilot birth surveillance program in Eswatini. MV reported that CIPHER is funded by grants from ViiV Healthcare, Janssen, Viatris and Merck. CT has received grant funding from ViiV Healthcare (via Penta Foundation). Other authors did not report competing interests. Funding Information: Recent years have seen the emergence of electronic health‐related data systems in a number of HIV high prevalence countries that can assist surveillance efforts. Perhaps the most mature is in the Western Cape Province of South Africa, where approximately 15 years ago the provincial government invested in unique patient identifiers used across all public‐sector health services. With the support of research and other partners, the Western Cape Provincial Health Data Centre integrates multiple electronic sources of data at an individual level to identify healthcare system encounters as well as disease episodes, such as pregnancy or HIV [ 31, 32 ]. Through the US NIH‐funded International Epidemiology Database to Evaluate AIDS (IeDEA) consortium and funding from the Gates Foundation, pilot sentinel birth outcomes surveillance has been set up in the Western Cape (Western Cape Pregnancy Exposure Registry) and at the Moi Teaching and Referral Hospital in western Kenya. Funding Information: We gratefully acknowledge Olubukola Ayinde, Nahida Chakhtoura, Michelle Chevalier, Karen Cohen, Corinne de Vries, Patrick Jean-Philippe, Corinne Merle, Nyaradso Mgodi, Mark Mirochnick, Phillipa Musoke, Pamela Nawaggi, Anton Pozniak and Marie-Eve Raguenaud for their contributions as members of the IMPAACT Network and World Health Organization Virtual Workshop on Approaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections in Pregnant Women and the working group on surveillance. Publisher Copyright: {\textcopyright} 2022 World Health Organization; licensed by IAS.",

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T1 - Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

AU - Renaud, Françoise

AU - Mofenson, Lynne M.

AU - Bakker, Charlotte

AU - Dolk, Helen

AU - Leroy, Valeriane

AU - Namiba, Angelina

AU - Sahin, Leyla

AU - Shapiro, Roger

AU - Slogrove, Amy

AU - Thorne, Claire

AU - Vicari, Marissa

AU - Low‐Beer, Daniel

AU - Doherty, Meg

N1 - Funding Information: LM has received funding from World Health Organization as consultant on antiretroviral drugs in pregnancy; Elisabeth Glazer Pediatric AIDS Foundation is receiving research funding from ViiV for a pilot birth surveillance program in Eswatini. MV reported that CIPHER is funded by grants from ViiV Healthcare, Janssen, Viatris and Merck. CT has received grant funding from ViiV Healthcare (via Penta Foundation). Other authors did not report competing interests. Funding Information: Recent years have seen the emergence of electronic health‐related data systems in a number of HIV high prevalence countries that can assist surveillance efforts. Perhaps the most mature is in the Western Cape Province of South Africa, where approximately 15 years ago the provincial government invested in unique patient identifiers used across all public‐sector health services. With the support of research and other partners, the Western Cape Provincial Health Data Centre integrates multiple electronic sources of data at an individual level to identify healthcare system encounters as well as disease episodes, such as pregnancy or HIV [ 31, 32 ]. Through the US NIH‐funded International Epidemiology Database to Evaluate AIDS (IeDEA) consortium and funding from the Gates Foundation, pilot sentinel birth outcomes surveillance has been set up in the Western Cape (Western Cape Pregnancy Exposure Registry) and at the Moi Teaching and Referral Hospital in western Kenya. Funding Information: We gratefully acknowledge Olubukola Ayinde, Nahida Chakhtoura, Michelle Chevalier, Karen Cohen, Corinne de Vries, Patrick Jean-Philippe, Corinne Merle, Nyaradso Mgodi, Mark Mirochnick, Phillipa Musoke, Pamela Nawaggi, Anton Pozniak and Marie-Eve Raguenaud for their contributions as members of the IMPAACT Network and World Health Organization Virtual Workshop on Approaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections in Pregnant Women and the working group on surveillance. Publisher Copyright: © 2022 World Health Organization; licensed by IAS.

PY - 2022/7/19

Y1 - 2022/7/19

N2 - IntroductionAs new antiretrovirals (ARVs), including long-acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization.DiscussionThis paper highlights that although robust sources of safety data and surveillance programs exist, key challenges remain, including unknown denominators, reporting bias, under-reporting (e.g. in voluntary registries), few data sources from resource-limited settings (most are in North America and Europe), incomplete or inaccurate data (e.g. within routine medical records). However, recent experiences (e.g. with safety signals) and current innovations (e.g. electronic record use in resource-limited settings and defining adverse outcomes) provide momentum and building blocks for a new framework for active surveillance of ARV safety in pregnancy. A public health approach should be taken using data from existing sources, including registries of pregnancy ARV exposure and birth defects; observational surveillance and cohort studies; clinical trials; and real-world databases. Key facilitators are harmonization and standardization of outcomes, sharing of materials and tools, and data linkages between programs. Other key facilitators include the development of guidance to estimate sample size and duration of surveillance, ensuring strategic geographic diversity, bringing partners together to share information and engaging the community of women living with HIV.ConclusionsLooking ahead, critical steps to safely introduce new ARVs include (1) adopting harmonized standards for measuring adverse maternal, birth and infant outcomes; (2) establishing surveillance centres of excellence in areas with high HIV prevalence with harmonized data collection and optimized electronic health records linking maternal/infant data; and (3) creating targets and evaluation goals for reporting progress on implementation and quality of surveillance in pregnancy. The platform will be leveraged to ensure that appropriate contributions and strategic actions by relevant stakeholders are implemented.

AB - IntroductionAs new antiretrovirals (ARVs), including long-acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization.DiscussionThis paper highlights that although robust sources of safety data and surveillance programs exist, key challenges remain, including unknown denominators, reporting bias, under-reporting (e.g. in voluntary registries), few data sources from resource-limited settings (most are in North America and Europe), incomplete or inaccurate data (e.g. within routine medical records). However, recent experiences (e.g. with safety signals) and current innovations (e.g. electronic record use in resource-limited settings and defining adverse outcomes) provide momentum and building blocks for a new framework for active surveillance of ARV safety in pregnancy. A public health approach should be taken using data from existing sources, including registries of pregnancy ARV exposure and birth defects; observational surveillance and cohort studies; clinical trials; and real-world databases. Key facilitators are harmonization and standardization of outcomes, sharing of materials and tools, and data linkages between programs. Other key facilitators include the development of guidance to estimate sample size and duration of surveillance, ensuring strategic geographic diversity, bringing partners together to share information and engaging the community of women living with HIV.ConclusionsLooking ahead, critical steps to safely introduce new ARVs include (1) adopting harmonized standards for measuring adverse maternal, birth and infant outcomes; (2) establishing surveillance centres of excellence in areas with high HIV prevalence with harmonized data collection and optimized electronic health records linking maternal/infant data; and (3) creating targets and evaluation goals for reporting progress on implementation and quality of surveillance in pregnancy. The platform will be leveraged to ensure that appropriate contributions and strategic actions by relevant stakeholders are implemented.

KW - Supplement: Commentary

KW - Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy. Guest Editors: Elaine J. Abrams, Martina Penazzato

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KW - pregnancy

KW - safety

KW - adverse pregnancy outcomes

KW - surveillance

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KW - Breast Feeding

KW - HIV Infections - drug therapy - epidemiology - prevention & control

KW - Infant

KW - North America

KW - Pregnancy

KW - Anti-Retroviral Agents - adverse effects - therapeutic use

KW - Adolescent

KW - Female

KW - Child

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Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

Access to Document

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