30 July 2022 (Montreal, Canada) – The Journal of the International AIDS Society (JIAS) has launched a special issue, titled “Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy”, at AIDS 2022, the 24th International AIDS Conference.
The content of the special issue has been guided by Guest Editors Elaine J Abrams (ICAP at Columbia University) and Martina Penazzato (World Health Organization). The special issue is funded by the World Health Organization.
As antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are increasingly scaled up globally, a large number of people receiving antiretrovirals (ARVs) for treatment or prevention are of reproductive age and could become pregnant while on ART. However, therapeutics are rarely investigated in pregnant people, leaving women and their providers to deal with uncertainty around the effectiveness and safety of various medications for themselves and their babies. Multiple agencies and actors have voiced their concerns about the exclusion of pregnant women from clinical trials and the associated harms and risks of these policies. A conceptual shift is required to ensure that pregnant people have equal access to medical innovation in HIV treatment and prevention.
The collection of articles in this special issue argues for the need to reframe the current approach: - From pregnant women as a vulnerable population to a complex population
- From protection from research to protection through research
- From presumptive exclusion to fair inclusion
Timely investigation of novel agents requires earlier completion of pre-clinical studies and better support for people who become pregnant during the conducting of studies of new agents and want to continue to receive the study drug. As the articles in this supplement discuss, pharmacokinetics and early safety data should be generated before market authorization, and dedicated studies to fully explore maternal and infant outcomes should be initiated for priority products with anticipated broad use.
Taken together, the principles and approaches discussed in this supplement chart a path to enable pregnant and breastfeeding people to be included early in registrational studies. Innovations discussed in the articles have the potential to disrupt the status quo and transform the way we include pregnant people in HIV drug research. Accelerating the introduction of new ARVs for this population and allowing for better regimen harmonization across populations will, in turn, improve ART and PrEP scale-up efforts.
Access the special issue here: https://bit.ly/JIAS_Pregnancy The Journal of the International AIDS Society (JIAS) is the official peer-reviewed journal of the IAS. Founded in 2004, it is an open-access, PubMed- and Medline-indexed journal. JIAS articles are published online on an article-by-article basis. The journal’s primary purpose is to provide an open-access platform for the generation and dissemination of evidence from a wide range of HIV-related disciplines, encouraging research from low- and middle-income countries. In addition, JIAS aims to strengthen capacity and empower less-experienced researchers from resource-limited countries.
For more information, visit www.jiasociety.org. IAS – the International AIDS Society – convenes, educates and advocates for a world in which HIV no longer presents a threat to public health and individual well-being. After the emergence of HIV and AIDS, concerned scientists created the IAS to bring together experts from across the world and disciplines to promote a concerted HIV response. Today, the IAS and its members unite scientists, policy makers and activists to galvanize the scientific response, build global solidarity and enhance human dignity for all those living with and affected by HIV. The International AIDS Conference, the IAS Conference on HIV Science and the HIV Research for Prevention Conference. For more information, visit www.iasociety.org. | 
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