JIAS Special Issue: ‘Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy’

The Journal of the International AIDS Society announces the launch of a new special issue entitled ‘Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy’. This supplement was guest edited by Martina Penazzato (World Health Organization) and Elaine Abrams (ICAP at Columbia University). This work builds on the strong and ongoing collaboration between WHO and IMPAACT, following the Call-to-Action to accelerate the study of new drugs for HIV in pregnancy.

With more than 19 million women living with HIV worldwide – of whom the majority are of reproductive potential – there is a public health imperative to obtain safety and pharmacokinetic data on antiretroviral drugs in pregnancy. Pregnant women are usually excluded from registrational trials of new agents, and safety and pharmacokinetics data for new drugs in pregnancy are routinely delayed by years to decades after initial drug approval, if available at all. In the current paradigm, pregnant women are not eligible for clinical trials of antiretroviral drugs for treatment or prevention, and young women who are not pregnant are oftentimes required to use dual contraception to participate in any clinical trial, while those who become pregnant while on study must discontinue the study drug. Multiple agencies and actors have voiced their concerns around the exclusion of pregnant women from clinical trials and the associated harms and risks of these policies. More recently, the importance of allowing pregnant women the opportunity to take part in clinical trials has received renewed attention during the COVID-19 pandemic. 

The articles in this special issue reflect on the changes needed to accelerate the inclusion of pregnant women in trials of new antiretrovirals and discuss tangible, actionable steps towards real equity in research and, ultimately, equity in access to new HIV medications for this population.

As noted by the Guest Editors: “We must fast-forward to a future when woman of reproductive age will no longer shoulder the burden of having fewer options to stay HIV-free or remain healthy and break the chain of HIV transmission.” This special issue charts a path forward from theory to action – to reach equity in research and contribute to end the HIV epidemic as a public health threat.

Members of the IMPAACT Network who co-authored or supported this work include: 

Elaine Abrams, Shahin Lockman, Dhayendre Moodley, Lee Fairlie, Lameck Chinula, Patricia Flynn, Sheryl Zwerski, Sean Brummel, Jeff Stringer, Camlin Tierney, Benjamin H. Chi, Brookie M. Best, Gonzague Jourdain, Sharon Nachman, and Lynda Stranix-Chibanda.

Access the supplement here.