Article and Study Summary:
Article
Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons
Published in:
N Engl J Med. Published online November 27, 2024. https://doi.org/10.1056/NEJMoa2411858
Authors:
Kelley CF, Acevedo-Quiñones M, Agwu AL, et al for the PURPOSE 2 Study Team.
Summary
This phase 3, multi-center, double-blind, randomized, active-controlled trial (PURPOSE 2) evaluated the efficacy and safety of twice-yearly subcutaneous lenacapavir as pre-exposure prophylaxis (PrEP) for HIV prevention in men and gender-diverse persons in the United States, Brazil, Thailand, South Africa, Peru, Argentina and Mexico. HIV-negative cisgender gay, bisexual, and other men, transgender women, transgender men, and gender nonbinary persons who have condomless receptive anal sex with partners assigned male at birth were randomized in a 2:1 ratio to receive subcutaneous lenacapavir every 26 weeks or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF) as an active control. All participants also received subcutaneous or oral placebo. The primary outcome was the efficacy of lenacapavir to prevent HIV infection, assessed by comparison to the estimated background HIV incidence in the screened population and HIV incidence in the F/TDF group. Among 3,265 randomized participants, 11 incident HIV infections were observed: 2 in the lenacapavir group and 9 in the F/TDF group. HIV incidence with lenacapavir was 96% lower than the background incidence (incidence rate ratio [IRR] 0.04; 95% confidence interval [CI], 0.01 to 0.18; p<0.001), and 89% lower than with F/TDF (IRR 0.11; 95% CI, 0.02 to 0.51; p=0.002). No safety concerns were found, but injection-site reactions were more common in the lenacapavir group than in the placebo injection group, with 26 participants discontinuing lenacapavir due to injection-site reactions. The randomized, blinded phase of the trial was stopped early after an interim efficacy analysis. Lenacapavir could have a substantial impact on global HIV prevention efforts if it is made available for the most at-risk populations, as it is a highly efficacious PrEP option that is long-acting and discreet.
Full Synopsis:
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