Summary

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• This summary is based on the review of two randomized controlled trials. ^[1-2]
• Among cisgender men, transgender women, transgender men, and gender-nonbinary persons, human immunodeficiency virus (HIV) incidence was 0.10 per 100 person-years (95% confidence interval [CI], 0.01 to 0.37) in the lenacapavir group, compared to 0.93 per 100 person-years (95% CI, 0.43 to 1.77) in the emtricitabine/tenofovir disoproxil fumarate (F/TDF) group and 2.37 per 100 person-years (95% CI, 1.65 to 3.42) in the background incidence; lenacapavir was associated with significantly lower incidence compared to F/TDF (incidence rate ratio [IRR], 0.11; 95% CI, 0.02 to 0.51; P = 0.002) and background incidence (IRR, 0.04; 95% CI, 0.01 to 0.18; P < 0.001).
• Among adolescent girls and young women in South Africa and Uganda, HIV incidence was 0 per 100 person-years (95% CI, 0.00 to 0.19) in the lenacapavir group, compared to 2.02 per 100 person-years (95% CI, 1.44 to 2.76) in the emtricitabine/tenofovir alafenamide (F/TAF) group, 1.69 per 100 person-years (95% CI, 0.96 to 2.74) in the F/TDF group, and 2.41 per 100 person-years (95% CI, 1.82 to 3.19) in the background incidence; lenacapavir showed significantly lower incidence than both F/TDF (IRR, 0.00; 95% CI, 0.00 to 0.10; P < 0.001) and background incidence (IRR, 0.00; 95% CI, 0.00 to 0.04; P < 0.001), with no significant difference between F/TAF and F/TDF (IRR, 1.20; 95% CI, 0.67 to 2.14).
• In cisgender men, transgender women, transgender men, and gender-nonbinary persons, 1.2% (26 of 2183) in the lenacapavir group discontinued due to injection-site reactions, compared to 0.3% (3 of 1088) in the F/TDF group; no safety concerns identified.
• In adolescent girls and young women in South Africa and Uganda, injection-site reactions occurred in 68.8% of the lenacapavir group versus 34.9% in the placebo injection group; 0.2% (4 participants) discontinued due to injection-site reactions; no safety concerns found.