JIAS supplement, July 2022
HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group
The HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group is a technical body of experts on the investigation and use of drugs in pregnant and breastfeeding women for the prevention and treatment of HIV, hepatitis and sexually transmitted infections.
The Working Group
The HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group (PTWG) advises WHO on guidelines development and implementation, and on drug optimization work that aims to accelerate innovation and access for pregnant and breastfeeding women.
The PTWG was established in response to a call to action by WHO, IMPAACT and the International AIDS Society (IAS) to accelerate the study of new drugs for these populations. This call followed a series of meetings held in 2021–2022, which established a framework to facilitate and encourage the inclusion of pregnant and breastfeeding women in pre-licensure clinical trials. These discussions are outlined in a JIAS supplement published in 2022.
/global-hiv-hepatitis-and-stis-programmes-(hhs)/fig1-framework.png?sfvrsn=9528ed15_2 "fig1-framework")
Objectives
The overall aim of the PTWG is to advance timely and ethical research and introduction of new and safer HIV, hepatitis and STI medicines for pregnant and breastfeeding women by creating an enabling environment and fostering collaboration with international partners. More specifically, the group aims to:
- provide expert advice and inform WHO on matters relating to selecting, using, monitoring, and conducting research and development of medicines in pregnant and breastfeeding women for prevention and treatment of HIV, hepatitis and STIs; and
- provide expert advice to external stakeholders involved with investigation, delivery and surveillance and monitoring of the use of medicines in pregnant and breastfeeding women for prevention and treatment of HIV, hepatitis and STIs.
Working group co-chairs
Dr
Elaine
Abrams
Professor of Epidemiology and Pediatrics, Columbia University
Dr Abrams is a Professor of Epidemiology and Pediatrics at Columbia University Medical Center and Senior Director of Research at ICAP at Columbia University.
Learn more
Dr
Sinead
Delany-Moretlwe
Professor of Global Health and Infectious Diseases, University of the Witwatersrand
Dr Delany-Moretlwe is Professor of Global Health and Infectious Diseases at the University of the Witwatersrand and Director of Research at Wits RHI in Johannesburg.
Learn more
Dr
Shahin
Lockman
Associate Professor of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health
Dr Lockman is an infectious-disease trained clinician and joint principal investigator of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership.
Learn more
Dr
Catriona
Waitt
Professor of Clinical Pharmacology and Global Health, University of Liverpool
Dr Waitt is a Professor of Clinical Pharmacology and Global Health at the University of Liverpool. She leads the Maternal and Infant Lactation pharmacoKinetics (MILK) group at the Infectious Diseases Institute, Makerere University, Kampala, Uganda.
Learn moreMembers
| Elaine Abrams (co-chair) Columbia University, School of Public Health New York, NY, USA | Polly Clayden Independent London, UK |
| Sinead Delany-Moretlwe (co-chair) Wits RHI (Reproductive Health Institute), University of the Witwatersrand Johannesburg, South Africa | Désiré Dahourou ANRS, University of Toulouse Toulouse, France |
| Shahin Lockman (co-chair) Harvard University Boston, MA, USA | Naranjargal Dashdorj Onom Foundation Ulaanbaatar, Mongolia |
| Catriona Waitt (co-chair) University of Liverpool Liverpool, UK | Alpha Diallo ANRS Paris, France |
| Linda-Gail Bekker Desmond Tutu Foundation Cape Town, South Africa | Philippa Easterbrook Imperial College London, UK |
| Brookie Best University of California San Diego San Diego, CA, USA | Ahizechukwu Eke Johns Hopkins University Baltimore, MD, USA |
| Jessica Burry Unitaid Geneva, Switzerland | Manal El-Sayed Ain Shams University Cairo, Egypt |
| Alexandra Calmy Geneva University Geneva, Switzerland | Lee Fairlie Wits RHI (Reproductive Health Institute), University of the Witwatersrand Johannesburg, South Africa |
| Catherine Chappell University of Pittsburgh Medical Centre Pittsburgh, PA, USA | Beatriz Grinsztejn Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz Rio de Janeiro, Brazil |
| Ben Chi University of North Carolina Chapel Hill, NC, USA | Sharon Hillier University of Pittsburgh Pittsburgh, PA, USA |
| Lameck Chinula University of North Carolina Chapel Hill, NC, USA | Ali Judd University College London London, UK |
| Saye Khoo Liverpool University Liverpool, UK | Philippa Musoke Makerere University Kampala, Uganda |
| John Kinuthia Kenyatta Hospital Nairobi, Kenya | Angelina Namiba 4MNetwork of Mentor Mothers London, UK |
| Jeffrey Klausner University of California Los Angeles Los Angeles, CA, USA | Risa Hoffman University of California Los Angeles Los Angeles, CA, USA |
| Nagalineswaran Kumarasamy Voluntary Health Services Infectious Diseases Medical Centre Chennai, India | Chloe Orkin Chelsea and Westminster Hospital London, UK |
| Valeriane Leroy ANRS, University of Toulouse Toulouse, France | Nicole Salazar-Austin Johns Hopkins Medical Institute Baltimore, MD, USA |
| Alison Luckey Global Antibiotic Research & Development Partnership (GARDP) Geneva, Switzerland | Jeanne Sibiude Hôpital Louis Mourier Colombes, France |
| Anne Drapkin Lyerly University of North Carolina Chapel Hill, NC, USA | Lynda Stranix-Chibanda University of Zimbabwe and IMPAACT Harare, Zimbabwe |
| Imelda Mahaka Pangaea Zimbabwe Harare, Zimbabwe | Graham Taylor Imperial College London London, UK |
| Catia Marzolini University Hospital Basel Basel, Switzerland | Claire Thorne University College London London, UK |
| Jyoti Mathad Cornell University Ithaca, NY, USA | Andrew Vallely University of New South Wales Sydney, Australia |
| Mark H. Mirochnick Boston Medical Center Boston, MA, USA | Francois Venter Ezintsha, University of the Witwatersrand Johannesburg, South Africa |
| Oriol Mitjà Universitat de Vic – Universitat Central de Cataluny Barcelona, Spain |
Observers and WHO staff
Observers
| Yodit Belew US Food and Drug Administration Washington, DC, USA | Lori Newman Bill and Melinda Gates Foundation Washington, DC, USA |
| Angela Colbers Radboud University Nijmegen, Netherlands | George Siberry Columbia University Medical Center New York, NY, USA |
| Corinne de Vries European Medicines Agency Amsterdam, Netherlands | Prabha Viswanathan US Food and Drug Administration Washington, DC, USA |
| Shaffiq Essajee UNICEF New York, NY, USA | John Ward Task Force for Global Health Atlanta, GA, USA |
WHO secretariat
| Francoise Renaud Lead PTWG, HHS Geneva, Switzerland |
| Claire Townsend WHO consultant and PTWG focal point, HHS Geneva, Switzerland |
| Lynne Mofenson WHO consultant, HHS Washington, DC, USA |
| Michelle Rodolphe Technical lead, PrEP Geneva, Switzerland |
| Marco Vitoria Medical Officer, ART Geneva, Switzerland |
| Remco Peters Medical Officer, STIs Geneva, Switzerland |
Key areas of work
The group offers advice to WHO through gathering and reviewing existing bodies of evidence, assisting with its interpretation, and providing technical advice and input to the following WHO processes:
- WHO guidelines development
- WHO drug optimization processes, for example through the Conference on Antiretroviral Drug Optimization (CADO)
- WHO Advisory Committee on Safety of Medicinal Products (ACSoMP).
In addition, the group is responsible for facilitating and supporting strategic actions identified in the call to action and meeting report to accelerate the study of new drugs for HIV in pregnant and breastfeeding women, including:
- defining and implementing standards to optimize clinical research on new medications for pregnant and breastfeeding women, through the Antiretrovirals in Pregnancy Research Toolkit, an online platform launched at the AIDS conference in 2024;
- establishing a collaborative framework on surveillance of drugs in pregnancy and breastfeeding to enable a standardized approach to data collection in HIV prevention implementation studies;
- developing recommendations for dosing and pharmacokinetics of existing and new therapeutics;
- disseminating evidence and outcomes of technical consultations through peer-reviewed journals and specialist conferences to ensure optimal use of medicines in pregnant and breastfeeding women; and
- facilitating engagement with the community of women living with HIV, hepatitis or STIs to enable meaningful contribution and involvement in clinical research and policy development.
Meeting reports
All →
Meeting report – Seattle, Washington, United States of America – 23 February 2023
30 November 2021
Approaches to enhance and accelerate study of new drugs for HIV and associated infections in pregnant...
Multiple agencies and actors have voiced their concerns around the exclusion of pregnant women from clinical trials and the associated harm and risks of...
On 12 March 2020, WHO organized a think-tank meeting with people living with HIV, academics, researchers and key stakeholders to identify...
Related links
Related links
Global HIV, Hepatitis and Sexually Transmitted Infections Programmes
World Health Organization
20, Avenue Appia
1211 Geneva, 27 Switzerland