Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial

作者：Raphael J. Landovitz, Brett Hanscom, Meredith E. Clement, Trần Việt Hà, Esper G. Kallás, Manya Magnus, Omar Sued, Jorge Sánchez, Hyman Scott, Joe Eron, Carlos del Rı́o, Sheldon D. Fields, Mark A. Marzinke, Susan H. Eshleman, Deborah Donnell, Matthew A. Spinelli, Ryan Kofron, Richard Berman, Estelle Piwowar‐Manning, Paul A. Richardson, Philip A. Sullivan, Jonathan Lucas, Peter L. Anderson, Craig W. Hendrix, Adeola Adeyeye, James F. Rooney, Alex R. Rinehart, Myron S. Cohen, Marybeth McCauley, Beatriz Grinsztejn · 发表于：The Lancet HIV · 年份：2023 · DOI：10.1016/s2352-3018(23)00261-8 · 被引用次数：70 · 研究领域：HIV/AIDS Research and Interventions、HIV/AIDS drug development and treatment、HIV Research and Treatment

BACKGROUND: Injectable cabotegravir was superior to daily oral tenofovir disoproxil fumarate plus emtricitabine for HIV prevention in two clinical trials. Both trials had the primary aim of establishing the HIV prevention efficacy of long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) compared with tenofovir disoproxil fumarate plus emtricitabine daily oral PrEP. Long-acting PrEP was associated with diagnostic delays and integrase strand-transfer inhibitor (INSTI) resistance. This report presents findings from the first unblinded year of the HIV Prevention Trials Network (HPTN) 083 study. METHODS: The HPTN 083 randomised controlled trial enrolled HIV-uninfected cisgender men and transgender women at elevated HIV risk who have sex with men, from 43 clinical research sites in Africa, Asia, Latin America, and the USA. Inclusion criteria included: a negative HIV serological test at the screening and study entry, undetectable HIV RNA levels within 14 days of study entry, age 18 years or older, overall good health as determined by clinical and laboratory evaluations, and a creatinine clearance of 60 mL/min or higher. Participants were randomly allocated to receive long-acting injectable cabotegravir or daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP. After study unblinding, participants remained on their original regimen awaiting an extension study. HIV infections were characterised retrospectively at a central laboratory. Here we report the seconda...