Long-acting injectable cabotegravir (CAB-LA) has been found to be well tolerated among pregnant women, according to a study presented at AIDS 2024, the 25th International AIDS Conference in Munich.
The research, led by Sinead Delany-Moretlwe, M.B.B.Ch., Ph.D., from the University of the Witwatersrand, examined maternal safety and pregnancy outcomes in 2,472 participants from the HPTN 084 open-label extension. The study compared pregnancies with exposure to CAB-LA during pregnancy, CAB-LA before pregnancy, and no CAB-LA exposure (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC]).
During 3,118 person-years, researchers recorded 351 pregnancies among 334 participants, yielding an incidence rate of 11.3 pregnancies per 100 person-years. The median time from the last CAB-LA injection to pregnancy detection was eight weeks for those using CAB-LA during pregnancy and 13 weeks for those with prior use. Participants exposed to CAB-LA during pregnancy received a median of four injections. No maternal deaths were reported.
Pregnancy-related maternal adverse events occurred at rates of 43.7, 52.9, and 40.0 per 100 person-years in the CAB-LA during pregnancy, CAB-LA before pregnancy, and no CAB-LA exposure groups, respectively. Rates of poor pregnancy outcomes were similar across all groups, with adverse outcomes in 28%, 35%, and 26% of pregnancies, respectively. Only one major congenital anomaly was noted in the CAB-LA during pregnancy group.
Delany-Moretlwe emphasized the importance of these findings, stating, “We hope that these results address a critical knowledge gap and facilitate increased access to this effective HIV preexposure prophylaxis option for cisgender women before, during, and after pregnancy.”