HPTN=HIV Prevention Trials Network; OLE=open-label extension; PrEP=pre-exposure prophylaxis.
APRETUDE: the First and Only Long-acting Injectable PrEP Option
*HPTN 083 (N=4,566) was a randomized, double-blind, controlled noninferiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1–uninfected men and transgender women who have sex with men and who have evidence of high-risk behavior for HIV-1 infection. The primary endpoint was rate of incident HIV-1 infection. The trial included the prespecified ability to test for superiority of APRETUDE over TDF/FTC.1
†HPTN 084 (N=3,224) was a randomized, double-blind, controlled superiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in adult, uninfected, cisgender women at risk of acquiring HIV-1. The primary endpoint was rate of incident HIV-1 infection.2
TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
APRETUDE Trial Design, Efficacy, and Safety
CBTWCNT230032
References:
Landovitz RJ, Donnell D, Clement ME, et al; HPTN 083 Study Team. 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; HPTN 084 study group. 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
HIV diagnoses. Centers for Disease Control and Prevention. Updated June 21, 2023. Accessed August 2, 2023. https://www.cdc.gov/hiv/statistics/overview/in-us/diagnoses.html
In Danger: Global AIDS Update 2022. Joint United Nations Programme on HIV/AIDS (UNAIDS); 2022. Accessed August 2, 2023. https://www.unaids.org/en/resources/documents/2022/in-danger-global-aids-update
Clement ME, Wang Z, Fichternbaum C, et al. Pre-exposure prophylaxis product choice in United States participants in HPTN 083. Poster presented at: 30th Conference on Retroviruses and Opportunistic Infections; February 19-22, 2023; Seattle, WA.