Twice-Yearly Lenacapavir Effective for HIV Infection Prevention in Men, Gender-Diverse Persons

Background: Prevention of HIV infection remains an important public health priority. Although prior studies have shown twice-yearly subcutaneous injections of lenacapavir to be effective in preventing HIV infection in cisgender women, its efficacy in other populations remains unknown. Objective: To investigate the efficacy of twice-yearly subcutaneous lenacapavir in preventing HIV infection among men and gender-diverse persons. Design: Phase 3, multicenter, double-blind randomized trial (The PURPOSE 2 study). Participants/Methods: Participants were randomized 2:1 to receive either twice-yearly subcutaneous lenacapavir or oral, daily emtricitabine–tenofovir disoproxil fumarate (F/TDF) plus placebo injections (internal control). Participants were recruited across 92 sites with evidence of ongoing HIV transmission. Eligible participants included cisgender gay, bisexual, and other men, transgender women, transgender men, and gender-nonbinary persons who engage in condomless recepti more...