Cabotegravir Injection Safe for HIV Prevention in Pregnancy

On July 23, 2024, it was revealed that long-acting injectable cabotegravir (CAB-LA) has shown to be safe and well-tolerated as an HIV pre-exposure prophylaxis (PrEP) both before and during pregnancy. This information emerged from a global study focusing on cisgender women, and the findings are set to be presented at the 2024 International AIDS Conference in Munich, Germany. The research analyzed outcomes from over 300 pregnancies and infants.

Cisgender women undergo biological changes and social dynamics that increase their risk of acquiring HIV during pregnancy and postpartum. Offering evidence-based options during these critical periods is essential. Jeanne Marrazzo, M.D., M.P.H., director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), emphasized that the new data provide reassuring evidence regarding the use of long-acting injectable cabotegravir for HIV prevention during pregnancy.

CAB-LA, administered via intramuscular injection every two months, is a highly effective method for HIV prevention. However, data on its safety during pregnancy has been limited. This study, an open-label extension of the CAB-LA efficacy trial, included cisgender women from East and Southern Africa who had the potential to become pregnant and were HIV-negative. Participants could choose between CAB-LA or oral PrEP with tenofovir disoproxil fumarate and emtricitabine, and had the option to use contraception. They were monitored closely for safety, with those who became pregnant also being observed for pregnancy-related adverse events and infant outcomes.

The study recorded 367 pregnancies and found that the incidence of pregnancy-related maternal adverse events was 45.7, 47.1, and 37.5 per 100 person years among women using CAB-LA during pregnancy, prior to pregnancy, or with no CAB-LA use, respectively. Adverse infant outcomes were reported in 33%, 38%, and 27% of pregnancies with CAB-LA use, prior CAB-LA use, or no CAB-LA use, respectively. One major congenital anomaly was noted in a participant receiving CAB-LA, and no maternal deaths occurred. The pregnancy and infant outcomes in the study were similar to general population estimates.

Overall, CAB-LA was found to be safe and well-tolerated, demonstrating its safety for use prior to and during pregnancy. Sinead Delany-Moretlwe, M.B.B.Ch., Ph.D., director of Research at Wits RHI and professor of Global Health and Infectious Diseases at the University of the Witwatersrand, Johannesburg, noted the overlap between high HIV incidence and the specific risks faced by cisgender pregnant women. She highlighted the need for diverse and effective PrEP options as part of sexual and reproductive health approaches, hoping that the findings will help increase access to this highly effective HIV PrEP option among cisgender women before, during, and after pregnancy.

The study was conducted by the NIH-funded HIV Prevention Trials Network (HPTN), with NIAID sponsoring and co-funding the trial alongside ViiV Healthcare and the Bill & Melinda Gates Foundation. Study medications were provided by ViiV Healthcare and Gilead Sciences, Inc. The NIH’s National Institute of Mental Health, National Institute on Drug Abuse, and Eunice Kennedy Shriver National Institute of Child Health and Human Development also collaborated with NIAID on this study.