GROUP SEQUENTIAL TESTING TRIAL
The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. The intention-to-treat population included 4566 participants who underwent randomization 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The primary end point was incident HIV infection. HIV testing and safety evaluations were performed. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor ) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate–emtricitabine (TDF–FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection.
GROUP SEQUENTIAL TESTING LICENSE
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