Superior efficacy versus a daily oral PrEP (TRUVADA) demonstrated in two clinical trials1,2*
*HPTN 083 (N=4566) and HPTN 084 (N=3244) were randomized, double-blind, controlled trials evaluating the safety and efficacy of APRETUDE every 2 months vs daily oral TRUVADA for HIV-1 prevention in adults at risk of acquiring HIV-1. The primary endpoint of both studies was the rate of incident HIV-1 infections.
Randomized, double-blind, multinational, controlled trials of APRETUDE vs TRUVADA in diverse study populations1,2
Noninferiority trial with the prespecified ability to test for superiority
43 sites around the world
- US, n=1698 (37%)
DEMOGRAPHICS:
- 68% were <30 years old
- 87% were MSM; 13% were TGW
- 18% in the US were Latinx; 50% in the US were Black/African American
MSM=men who have sex with men; TGW=transgender women.
Superiority trial
20 sites around sub-Saharan Africa
DEMOGRAPHICS:
- 50% were <25 years old
- 55% had ≥2 sex partners
PMUS-CBTWCNT250019
References:
Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi:10.1056/NEJMoa2101016
Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399(10337):1779-1789. doi:10.1016/S0140-6736(22)00538-4