NEJM

Twice-yearly injection effective for HIV prevention in men, gender diverse individuals

December 4, 2024

Study design: The phase 3 PURPOSE 2 trial compared the efficacy of twice-yearly injectable lenacapavir vs. daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF) for HIV prevention among 2,179 participants, including gay and bisexual men, trans men, trans women, and gender-diverse individuals across multiple countries.

Results: Lenacapavir demonstrated a 96% reduction in HIV acquisition risk compared with daily oral PrEP. Only two participants in the lenacapavir group acquired HIV vs. nine in the oral PrEP group. Incidence of HIV infection in the lenacapavir group was significantly lower than both the background incidence (incidence rate ratio [IRR], 0.04; 95% CI, 0.01-0.18; P<0.001) and the incidence in the F/TDF group (IRR, 0.11; 95% CI, 0.02-0.51; P=0.002). No new safety concerns were identified.

Impact on clinical practice: Use of lenacapavir as biannual injectable PrEP could significantly enhance HIV prevention strategies, particularly for individuals facing challenges with daily oral medication adherence.

Source:

Kelley CF, et al; PURPOSE 2 Study Team. (2024, November 27). N Engl J Med. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. https://pubmed.ncbi.nlm.nih.gov/39602624/