Using long-acting injectable cabotegravir to prevent HIV in pregnant women is not harmful

Press release

Tuesday July 23, 2020

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The NIH-sponsored study recommends cabotegravir throughout the reproductive period.

Transmission electron microscope of HIV-1 particles (green), replicating in the membrane of an H9 T cell (pink).NIAID

In the final phase of an international study, long-acting injectable cabotegravir was found to be well tolerated and safe as HIV pre-exposure prophylaxis. An analysis of more than 300 pregnancy and newborn outcomes will be conducted at the International AIDS Conference 2024 in Munich (AIDS 2024).

The National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH), led by Jeanne Marrazzo MDMPH. These data are reassuring about the use of long-acting cabotegravir to prevent HIV during pregnancy.

CAB-LA stands for California Cab Company. Highly effective HIV prevention methodIntramuscular injection every 2 months. There are limited data on the safety of CABLA in pregnancy. Women from eastern and southern Africa, able to become pregnant and not living with HIV, participated in an open-label study of the CAB LA efficacy study. Participants could choose between CABLA and oral PrEP containing tenofovir dioproxil fumarate, emtricitabine, or a combination of both. They also had the choice of using contraception. Safety was closely monitored. Participant safety was closely monitored.

This phase of the study included 367 pregnancies. The incidence of maternal adverse pregnancy-related events was 45.7, 47.1, and 37.5 per 100 person-years for those who used CABLA before or during pregnancy. Adverse infant outcomes were similar in all groups. Adverse outcomes were reported in 33%, 38.5%, and 27.5% pregnant women who used CABLA either during or before pregnancy. One participant who received CAB-LA was diagnosed with a major congenital anomaly. No maternal deaths occurred. The study's pregnancy and infant outcomes were comparable to those estimated for the general population.

CAB-LA was well tolerated and generally safe. The results show that CAB-LA can be used safely before and during pregnancy.

The overlap between high HIV prevalence and the risks that pregnant cisgender women face in many countries for acquiring HIV requires diverse and effective PrEP as part of sexual and reproductive approaches, said Sinead Delay-Moretlwe. She is a research director at the Wits Research Institute and professor of global health and infectious diseases at the University of the Witwatersrand in Johannesburg. We hope these findings fill an important knowledge gap that could help increase access to PrEP for pregnant cisgender women before, during and after pregnancy.

The NIH-funded HIV Prevention Trials Network is responsible for conducting and implementing this study. The trial is co-funded by NIAID, ViiV Healthcare, and the Bill & Melinda Gates Foundation. ViiV Healthcare, Gilead Sciences, Inc., and the Bill & Melinda Gates Foundation are providing the study drug. The National Institute of Mental Health (NIMH), the National Institute on Drug Abuse, and Eunice Kennedy Shriver The National Institute of Child Health and Human Development and NIAID collaborated on this study.

Visit ClinicalTrials.gov and enter the study ID to learn more about HPTN 084. NCT03164564.

NIAID supports and conducts research at NIH, in the United States, and around the world to study and develop new methods for diagnosing, preventing, and treating infectious and immune-mediated diseases. On the NIAID website, you can find news releases, fact sheets, and other NIAID materials. NIAID website.

The National Institutes of Health: NIH is the medical research agency of the United States Department of Health and Human Services. It includes 27 institutes and centers. The NIH, the nation's medical research agency, is a component of the U.S. Department of Health and Human Services. It is responsible for conducting basic, translational, clinical and other medical research. Visit NIH for more information about its programs and services. www.nih.gov.

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