Long-acting injectable cabotegravir (CAB-LA) was found to be safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in a global study involving cisgender women. The results from analyzing over 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
“Cisgender women undergo biological changes and social circumstances that can increase their risk of acquiring HIV during pregnancy and the postnatal period. It is essential to provide them with evidence-based options when they need them the most,” said Dr. Jeanne Marrazzo, the director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). “These findings provide assurance regarding the safety of long-acting injectable cabotegravir for HIV prevention during pregnancy.”
CAB-LA is a highly effective method for preventing HIV, administered through intramuscular injections every two months. However, there has been limited data on the safety of CAB-LA during pregnancy. An open-label extension study of the CAB-LA efficacy trial in cisgender women was conducted in multiple countries across East and Southern Africa. The study included women who could potentially become pregnant during the research and didn’t have HIV. Participants had the choice between CAB-LA and oral PrEP with tenofovir disoproxil fumarate and emtricitabine, and they could opt for contraception if desired. Close monitoring for safety was conducted. Pregnant participants were also closely monitored for pregnancy-related adverse events like gestational hypertension, pre-eclampsia, weight gain, and infant outcomes such as miscarriage, stillbirth, premature birth, or low birthweight.
During this phase of the study, there were 367 pregnancies. The incidence of pregnancy-related maternal adverse events was 45.7, 47.1, and 37.5 per 100 person-years in individuals using CAB-LA during pregnancy, before pregnancy, or not using CAB-LA, respectively. Adverse infant outcomes were similar in all groups, with negative outcomes reported in 33%, 38%, and 27% of pregnancies among those using CAB-LA during pregnancy, prior CAB-LA use, or no CAB-LA use, respectively. One participant receiving CAB-LA reported a major congenital anomaly. No maternal deaths were recorded. The pregnancy and infant outcomes were comparable to the estimated outcomes in the general population.
Overall, CAB-LA was deemed safe and well tolerated. The results confirm the safety of using CAB-LA before and during pregnancy.
“The intersection of high HIV incidence and the specific risks faced by cisgender pregnant women in acquiring HIV in many regions underscores the need for diverse and highly effective PrEP options as part of sexual and reproductive health strategies,” stated study chair Dr. Sinead Delany-Moretlwe, the director of Research at Wits RHI and a professor of Global Health and Infectious Diseases at the University of the Witwatersrand, Johannesburg. “We anticipate that these findings can help address a crucial knowledge gap and enhance access to this highly effective HIV PrEP option for cisgender women before, during, and after pregnancy.”
This study is sponsored and supported by the NIH-funded HIV Prevention Trials Network (HPTN). NIAID collaborates on the trial with ViiV Healthcare and the Bill & Melinda Gates Foundation. Study medications are 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 worked together with NIAID on this study.
For more information about this trial, known as HPTN 084, please visit ClinicalTrials.gov using the study identifier NCT03164564.
