Long-acting injectable cabotegravir for HIV prevention safe in pregnancy, suggests study

Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.

“Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”

CAB-LA is a highly effective HIV prevention method, administered by intramuscular injection every two months. However, data regarding the safety of CAB-LA during pregnancy are limited. An open-label extension study of the CAB-LA efficacy trial in cisgender women included women in several countries across East and Southern Africa who had the potential to become pregnant during the longitudinal study and who did not have HIV. Participants chose between CAB-LA or oral PrEP with tenofovir disoproxil fumarate and emtricitabine and had the option to use contraception if they wished. They were monitored closely for safety. Participants who became pregnant also were monitored for pregnancy-related adverse events including gestational hypertension, pre-eclampsia, and weight gain, as well as infant outcomes, such as miscarriage, intrauterine fetal death or stillbirth, premature birth, or low birthweight.