PURPOSE 2
Trial question
What is the role of twice-yearly lenacapavir for the prevention of HIV infection in men and gender-diverse individuals?
Study design
Multi-center
Double blinded
RCT
Population
3271 patients (undefined female, 2543 male).
Inclusion criteria: men and gender-diverse individuals who were HIV-negative.
Key exclusion criteria: prior use of HIV pre-exposure or post-exposure prophylaxis in the past 12 weeks; acute HAV, HBV, or HCV or chronic HBV or hepatitis C hepatitis infection; severe hepatic impairment or decompensated liver cirrhosis; prior recipient of an HIV vaccine.
Interventions
N=2183 lenacapavir (at a SC dose of 927 mg as two 1.5 mL injections every 26 weeks).
N=1088 F/TDF (at an oral dose of emtricitabine 200 mg daily and tenofovir disoproxil fumarate 300 mg daily).
Primary outcome
Incidence of incidence of human immunodeficiency virus infection
0.1
0.93
0.9/100 py
0.7/100 py
0.5/100 py
0.2/100 py
0.0/100 py
Lenacapavir
F/TDF
Significant
decrease ▼
Significant decrease in the incidence of incidence of HIV infection (0.1/100 py vs. 0.93/100 py; IRR 0.11, 95% CI 0.02 to 0.51).
Secondary outcomes
Significant decrease in the incidence of background incidence of HIV infection (0.1/100 py vs. 2.37/100 py; IRR 0.04, 95% CI 0.01 to 0.18).
Safety outcomes
No significant differences in adverse events, serious adverse events.
Conclusion
In men and gender-diverse individuals who were HIV-negative, lenacapavir was superior to F/TDF with respect to the incidence of incidence of HIV infection.
Reference
Colleen F Kelley, Maribel Acevedo-Quiñones, Allison L Agwu et al. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2025 Apr 3;392(13):1261-1276.
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