A RECENT Phase 3 clinical trial highlights the potential of twice-yearly subcutaneous lenacapavir as an effective preexposure prophylaxis (PrEP) option for diverse populations at risk of HIV infection.
While the efficacy of twice-yearly subcutaneous lenacapavir for HIV prevention has previously been demonstrated in cisgender women, its efficacy for PrEP in cisgender men, transgender women, transgender men, and gender-nonbinary persons is still unclear.
The double-blind, randomised, active-controlled trial enrolled 3,265 participants, assigning them to either lenacapavir every 26 weeks or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF) in a 2:1 ratio. Efficacy analyses examined HIV incidence in the lenacapavir group compared to both the background HIV incidence in the screened population and the F/TDF group.
Over the course of the study, the lenacapavir group experienced a significantly lower rate of HIV infection, with only 2 cases (0.10 per 100 person-years), compared to 9 cases in the F/TDF group (0.93 per 100 person-years). Notably, the background HIV incidence in the screened population was 2.37 per 100 person-years. The lenacapavir group demonstrated an incidence rate ratio of 0.04 compared to the background incidence (P<0.001) and 0.11 compared to the F/TDF group (P=0.002).
Safety data from the trial showed no major concerns. Injection-site reactions led to discontinuation in 1.2% of lenacapavir recipients and 0.3% of F/TDF participants.
These findings indicate that twice-yearly lenacapavir could be a highly effective, long-acting PrEP option, particularly for individuals seeking alternatives to daily oral regimens. This innovative approach could mark a significant step forward in HIV prevention efforts.
Ada Enesco, EMJ
Reference
Kelley CF et al. Twice-yearly lenacapavir for HIV prevention in men and gender-diverse persons. N Engl J Med. 2024; DOI:10.1056/NEJMoa2411858.
