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The following is a summary of “Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons,” published in the November 2024 issue of Infectious Disease by Kelley et al. 

Researchers conducted a retrospective study to evaluate the efficacy in cisgender men, transgender women, transgender men, and gender-nonbinary individuals of twice-yearly subcutaneous lenacapavir for preexposure prophylaxis (PrEP). 

They randomly assigned the participants in a 2:1 ratio to receive subcutaneous lenacapavir every 26 weeks or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF). The primary efficacy analysis compared the incidence of HIV infection in the lenacapavir group with the background HIV incidence in the screened population. The secondary efficacy analysis compared the incidence of HIV infection between the lenacapavir group and the F/TDF group.  

The results showed that among 3,265 participants in the modified intention-to-treat analysis, 2 participants in the lenacapavir group (0.10 per 100 person-years; 95% CI, 0.01 to 0.37) and 9 participants in the F/TDF group (0.93 per 100 person-years; 95% CI, 0.43 to 1.77) contracted HIV. The background HIV incidence in the screened population (4,634 participants) was 2.37 per 100 person-years (95% CI, 1.65 to 3.42).The HIV incidence in the lenacapavir group was significantly lower compared to both the background incidence (incidence rate ratio [IRR], 0.04; 95% CI, 0.01 to 0.18; P<0.001) and the F/TDF group (IRR, 0.11; 95% CI, 0.02 to 0.51; P=0.002). No safety concerns were reported, with 1.2% (26 of 2,183) of participants in the lenacapavir group and 0.3% (3 of 1,088) in the F/TDF group discontinuing due to injection-site reactions.  

Investigators concluded the twice-yearly lenacapavir significantly reduced HIV incidence compared to background incidence and F/TDF. 

Source: nejm.org/doi/full/10.1056/NEJMoa2411858