Long-acting injectable cabotegravir (CAB-LA) has demonstrated safety and tolerability as HIV pre-exposure prophylaxis (PrEP) for cisgender women before and during pregnancy, according to a recent analysis presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany. The study, which followed over 300 pregnancies, offers reassurance regarding the use of CAB-LA during this critical period.
The research addresses a significant gap in data concerning the safety of CAB-LA during pregnancy. CAB-LA, administered via intramuscular injection every two months, is a highly effective HIV prevention method. However, until now, comprehensive safety data for pregnant women were limited.
Study Details and Findings
The open-label extension study was conducted as part of the CAB-LA efficacy trial (HPTN 084) among cisgender women in East and Southern Africa. Participants were given the choice between CAB-LA and oral PrEP (tenofovir disoproxil fumarate and emtricitabine) and were closely monitored for safety. Pregnant participants were monitored for pregnancy-related adverse events, including gestational hypertension and pre-eclampsia, as well as infant outcomes like miscarriage, premature birth, and low birth weight.
The study reported on 367 pregnancies. Maternal adverse event incidence was 45.7, 47.1, and 37.5 per 100 person-years among those using CAB-LA during pregnancy, prior to pregnancy, or with no CAB-LA use, respectively. Adverse infant outcomes were similar across all groups, with negative outcomes reported in 33%, 38%, and 27% of pregnancies, respectively. Notably, one major congenital anomaly was reported in a participant receiving CAB-LA. No maternal deaths occurred, and overall pregnancy and infant outcomes mirrored those of the general population.
Expert Commentary
Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID), emphasized the importance of these findings. "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," she stated. "These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy."
Sinead Delany-Moretlwe, M.B.B.Ch., Ph.D., study chair and director of Research at Wits RHI, highlighted the broader implications. "The overlap between high HIV incidence and the specific risks that cisgender pregnant women face in acquiring HIV in many countries calls for diverse and highly effective PrEP options as part of sexual and reproductive health approaches," she said. "We hope that 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."
Implications for HIV Prevention
The study's results suggest that CAB-LA is a safe and well-tolerated option for HIV prevention in women who are pregnant or may become pregnant. This is particularly significant in regions with high HIV prevalence, where women face increased risk during pregnancy and the postnatal period. The availability of diverse and effective PrEP options is crucial for addressing this vulnerability and improving maternal and infant health outcomes.
The HPTN 084 trial is registered at ClinicalTrials.gov under the identifier NCT03164564. The trial is sponsored and co-funded by NIAID with ViiV Healthcare and the Bill & Melinda Gates Foundation. Study medications are provided by ViiV Healthcare and Gilead Sciences, Inc.
