NIH Study Confirms Safety of CAB-LA During Pregnancy

Long-acting injectable cabotegravir (CAB-LA) has been found to be safe and well-tolerated as an HIV pre-exposure prophylaxis (PrEP) before and during pregnancy, according to a follow-up study sponsored by the National Institutes of Health (NIH). This analysis, which includes outcomes from over 300 pregnancies and infants, will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.

Transmission electron micrograph of HIV-1 virus particles (green) replicating from the plasma membrane of an H9 T cell (pink).NIAID

Study Details and Findings

Dr. Jeanne Marrazzo, Director of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), highlighted the importance of providing evidence-based HIV prevention options for cisgender women during pregnancy and the postnatal period. The study assessed CAB-LA, a highly effective HIV prevention method administered via intramuscular injection every two months, for its safety during pregnancy. The study involved an open-label extension of the CAB-LA efficacy trial, with participants from East and Southern Africa who did not have HIV and had the potential to become pregnant. They chose between CAB-LA and oral PrEP with tenofovir disoproxil fumarate and emtricitabine, with an option to use contraception.

Safety and Adverse Outcomes

Throughout this phase of the study, which recorded 367 pregnancies, the incidence of pregnancy-related maternal adverse events was comparable among those using CAB-LA during pregnancy (45.7 per 100 person years), before pregnancy (47.1 per 100 person years), and those with no CAB-LA use (37.5 per 100 person years). Adverse infant outcomes were also similar across groups, with negative outcomes reported in 33% of pregnancies with CAB-LA use, 38% with prior CAB-LA use, and 27% with no CAB-LA use. Only one major congenital anomaly was reported among CAB-LA users. No maternal deaths were recorded, and overall, the outcomes were consistent with general population estimates.

Implications for HIV Prevention

Dr. Sinead Delany-Moretlwe, Chair of the study and Director of Research at Wits RHI, emphasized the need for diverse and effective PrEP options for cisgender women, particularly in areas with high HIV incidence. The study’s findings are expected to bridge a significant knowledge gap and potentially improve access to CAB-LA for women before, during, and after pregnancy.

Highlights

• Long-acting injectable cabotegravir (CAB-LA) is confirmed safe for HIV prevention during pregnancy.
• The study involved over 300 pregnancies and infants and will be presented at AIDS 2024.
• Maternal and infant outcomes with CAB-LA were similar to those without CAB-LA use.
• Findings support the use of CAB-LA as an effective PrEP option for cisgender women throughout pregnancy.
• The study aims to enhance access to effective HIV prevention options for women in high-incidence regions.

Data Source: https://www.nih.gov/news-events/news-releases/long-acting-injectable-cabotegravir-hiv-prevention-safe-pregnancy