Lengthy-acting injectable CAB-LA protected for HIV PrEP throughout being pregnant, examine finds

Lengthy-acting injectable cabotegravir (CAB-LA) was protected and nicely tolerated as HIV pre-exposure prophylaxis (PrEP) earlier than and through being pregnant within the follow-up section of a world examine amongst cisgender ladies. The evaluation of outcomes from greater than 300 pregnancies and infants might be introduced on the 2024 Worldwide AIDS Convention (AIDS 2024) in Munich, Germany. 

Cisgender ladies expertise organic modifications and social dynamics that may improve their probability of buying HIV throughout being pregnant and the postnatal interval, and we have to supply them evidence-based choices when they could want them most. These knowledge present reassurance about long-acting injectable cabotegravir for HIV prevention throughout being pregnant.”

Jeanne Marrazzo, M.D., M.P.H., Director of the Nationwide Institutes of Well being’s (NIH) Nationwide Institute of Allergy and Infectious Illnesses (NIAID)

CAB-LA is a extremely efficient HIV prevention methodology, administered by intramuscular injection each two months. Nonetheless, knowledge relating to the security of CAB-LA throughout being pregnant are restricted. An open-label extension examine of the CAB-LA efficacy trial in cisgender ladies included ladies in a number of nations throughout East and Southern Africa who had the potential to turn out to be pregnant in the course of the longitudinal examine and who didn’t have HIV. Individuals selected between CAB-LA or oral PrEP with tenofovir disoproxil fumarate and emtricitabine and had the choice to make use of contraception in the event that they wished. They have been monitored intently for security. Individuals who turned pregnant additionally have been monitored for pregnancy-related antagonistic occasions together with gestational hypertension, pre-eclampsia, and weight acquire, in addition to toddler outcomes, reminiscent of miscarriage, intrauterine fetal loss of life or stillbirth, untimely beginning, or low birthweight. 

There have been 367 pregnancies on this section of the examine. Being pregnant-related maternal antagonistic occasion incidence was 45.7, 47.1, and 37.5 per 100 individual years amongst folks utilizing CAB-LA throughout being pregnant, previous to being pregnant, or with no CAB-LA use, respectively. Hostile toddler outcomes have been comparable throughout teams, with unfavourable outcomes reported in 33%, 38%, and 27% of pregnancies with CAB-LA use, prior CAB-LA use, or no CAB-LA use, respectively. One main congenital anomaly was reported in a participant receiving CAB-LA. No maternal deaths occurred. Being pregnant and toddler outcomes within the examine have been much like estimated normal inhabitants outcomes.

General, CAB-LA was protected and nicely tolerated. These findings exhibit the security of utilizing CAB-LA previous to and through being pregnant. 

“The overlap between excessive HIV incidence and the particular dangers that cisgender pregnant ladies face in buying HIV in lots of nations requires numerous and extremely efficient PrEP choices as a part of sexual and reproductive well being approaches,” mentioned examine chair Sinead Delany-Moretlwe, M.B.B.Ch., Ph.D., director of Analysis at Wits RHI and professor of International Well being and Infectious Illnesses on the College of the Witwatersrand, Johannesburg. “We hope that these findings can fill an necessary data hole that may assist improve entry to this extremely efficient HIV PrEP choice amongst cisgender ladies earlier than, throughout, and after being pregnant.”

This examine is performed and carried out by the NIH-funded HIV Prevention Trials Community (HPTN). NIAID sponsors and co-funds the trial with ViiV Healthcare and the Invoice & Melinda Gates Basis. ViiV Healthcare and Gilead Sciences, Inc., present examine drugs. The NIH’s Nationwide Institute of Psychological Well being, Nationwide Institute on Drug Abuse, and Eunice Kennedy Shriver Nationwide Institute of Little one Well being and Human Improvement collaborated with NIAID on this examine.