Long-acting injectable cabotegravir for HIV prevention is safe during pregnancy

Press release

Tuesday July 23, 2024

NIH-sponsored study supports use of cabotegravir throughout reproductive potential.

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

Cisgender women experience biological changes and social dynamics that can increase their risk of HIV during pregnancy and the postpartum period, and we need to provide them with evidence-based options when they need them most, said Jeanne Marrazzo, MD, MPH, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). These data provide reassurance about the use of long-acting injectable cabotegravir for HIV prevention during pregnancy.

CAB-LA is a very effective HIV prevention methodadministered by intramuscular injection every other month. However, data regarding the safety of CAB-LA in pregnancy are limited. An open-label extension study of the CAB-LA efficacy trial in cisgender women included women from several countries in eastern and southern Africa who were of potential pregnancy during the longitudinal study and who were HIV-negative. Participants chose between CAB-LA or oral PrEP with tenofovir disoproxil fumarate and emtricitabine and were given the option to use contraception if they wished. They were closely monitored for their safety. Participants who became pregnant were also monitored for pregnancy-related adverse events, including gestational hypertension, preeclampsia, and weight gain, as well as infant outcomes, such as miscarriage, intrauterine fetal death or stillbirth, preterm birth, or low birth weight.

There were 367 pregnancies in this phase of the study. The incidence of pregnancy-related maternal adverse events was 45.7, 47.1, and 37.5 per 100 person-years among those using CAB-LA during pregnancy, before pregnancy, or without CAB-LA use, respectively. Adverse events in the infant were similar across groups, with adverse events reported in 33%, 38%, and 27% of pregnancies with CAB-LA use, prior CAB-LA use, or without CAB-LA use, respectively. One major congenital anomaly was reported in one participant receiving CAB-LA. No maternal deaths occurred. Pregnancy and infant outcomes in the study were similar to those estimated in the general population.

Overall, CAB-LA was found to be safe and well tolerated. These results demonstrate the safety of CAB-LA use before and during pregnancy.

The overlap between high HIV incidence and the specific risks that pregnant cisgender women face for HIV acquisition in many countries requires diverse and highly effective PrEP options as part of sexual and reproductive health approaches, said study chair Sinead Delany-Moretlwe, MBBCh., Ph.D., director of research at Wits RHI and professor of global health and infectious diseases at the University of the Witwatersrand, Johannesburg. We hope these findings can fill an important knowledge gap that can help increase access to this highly effective HIV PrEP option among cisgender women before, during and after pregnancy.

This study is being conducted and implemented by the NIH-funded HIV Prevention Trials Network (HPTN). NIAID is sponsoring and co-funding the trial with ViiV Healthcare and the Bill & Melinda Gates Foundation. ViiV Healthcare and Gilead Sciences, Inc. are providing the study drugs. The National Institute of Mental Health, the National Institute on Drug Abuse, and Eunice Kennedy ShriverThe National Institute of Child Health and Human Development collaborated with NIAID on this study.

For more information about this trial, called HPTN 084, please visit ClinicalTrials.gov using the study identifier NCT03164564.

NIAID conducts and supports research at NIH, in the United States, and around the world, to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets, and other NIAID-related materials are available at NIAID Website.

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