Evaluation of long-acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084
Citation
Delany-Moretlwe S, Hanscom B, Guo X, Nkabiito C, Mandima P, Nahirya PN, Mpendo J, Bhondai-Mhuri M, Mgodi N, Berhanu R, Farrior J, Piwowar-Manning E, Ford SL, Hendrix CW, Rinehart AR, Rooney JF, Adeyeye A, Landovitz RJ, Cohen MS, Hosseinipour MC, Marzinke. Evaluation of long-acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084. J Int AIDS Soc. 2025, 28: e26401. PMC11695207
Abstract
Introduction: Long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis significantly reduced HIV acquisition in HPTN 084. We report on the safety and CAB-LA pharmacokinetics in pregnant women during the blinded period of HPTN 084. Methods: Participants were randomized 1:1 to either active cabotegravir (CAB) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) placebo or active TDF/FTC plus CAB placebo. Pregnancy testing was performed at each visit; participants with a positive test had study product withheld and were offered open-label TDF/FTC. Pregnancies were confirmed on two tests at least 4 weeks apart. All participants with a positive pregnancy test prior to November 5, 2020 are included in this analysis. Pregnancy incidence, maternal adverse event (AE) incidence, pregnancy outcomes (including composite outcome of spontaneous abortion