Dallas, TX — A recent study has confirmed the safety and tolerability of long-acting injectable cabotegravir (CAB-LA) as HIV pre-exposure prophylaxis (PrEP) throughout pregnancy among cisgender women. The findings, based on a global study involving over 300 pregnancies, will be presented at the 2024 International AIDS Conference in Munich, Germany.
Dr. Jeanne Marrazzo, Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), emphasized the significance of offering effective HIV prevention options tailored to the unique biological and social dynamics faced by cisgender women during pregnancy and postnatal periods.
Administered via intramuscular injection every two months, CAB-LA has shown high efficacy in preventing HIV. However, concerns regarding its safety during pregnancy prompted further investigation. The study, an open-label extension of the CAB-LA efficacy trial, included participants from East and Southern Africa who were at risk of pregnancy and HIV-negative. Participants chose between CAB-LA and oral PrEP with tenofovir disoproxil fumarate and emtricitabine, with the option to use contraception.
Throughout the study, participants were closely monitored for safety, including pregnancy-related adverse events such as gestational hypertension, pre-eclampsia, and infant outcomes like premature birth and low birthweight. Results indicated comparable rates of adverse pregnancy-related events and infant outcomes across groups using CAB-LA during pregnancy, prior to pregnancy, or not using CAB-LA.
Overall, CAB-LA was well tolerated, with outcomes similar to those expected in the general population. These findings underscore the safety of CAB-LA use before and during pregnancy, offering reassurance for its inclusion in comprehensive sexual and reproductive health strategies.
Dr. Sinead Delany-Moretlwe, Study Chair and Director of Research at Wits RHI, highlighted the study’s potential to address critical gaps in understanding and access to effective HIV PrEP options for cisgender women throughout pregnancy and beyond.
The study, known as HPTN 084, is conducted by the NIH-funded HIV Prevention Trials Network (HPTN), in collaboration with ViiV Healthcare, the Bill & Melinda Gates Foundation, and other partners.
