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Lenacapavir: A Review in HIV Pre-Exposure Prophylaxis
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DOI：10.1007/s40265-026-02368-0.png)
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Abstract
En 中文
Lenacapavir [YEZTUGO® (USA); YEYTUO® (EU)] is the first twice‑yearly long‑acting injectable option to be approved for HIV pre‑exposure prophylaxis (PrEP). As a potent HIV capsid inhibitor, lenacapavir disrupts multiple stages of the viral replication cycle. Its slow absorption and long half‑life permit administration as a subcutaneous (SC) injection once every 6 months. Lenacapavir is indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing ≥ 35 kg who are at risk for HIV-1 acquisition. In two large phase III clinical trials, lenacapavir demonstrated efficacy in preventing HIV acquisition across diverse populations, including cisgender women, cisgender gay, bisexual, and other men, transgender women, transgender men, and gender-nonbinary persons who have sex with partners assigned male at birth. HIV incidence with lenacapavir was significantly lower than the background HIV incidence and the HIV incidence with daily oral PrEP (emtricitabine/tenofovir disoproxil fumarate). Adherence to lenacapavir was consistently high across both trials. Lenacapavir was generally well tolerated, with mostly mild or moderate injection‑site reactions (ISRs) that declined in frequency over time. With its convenient twice‑yearly dosing schedule and SC route of administration, lenacapavir represents a valuable addition to the current portfolio of HIV PrEP options. Pre‑exposure prophylaxis (PrEP) requires people who do not have HIV to take a pill every day to protect them from acquiring the infection. Daily oral PrEP with emtricitabine combined with tenofovir disoproxil fumarate or tenofovir alafenamide is highly effective for preventing HIV infection, but its impact is limited by poor adherence. Long‑acting injectable options with less frequent dosing schedules were developed to help address this challenge. Lenacapavir [YEZTUGO® (USA); YEYTUO® (EU)] is a first-in-class HIV capsid inhibitor that is designed for slow drug release and can be administered by SC injection twice a year. It is approved for PrEP in adults and adolescents at risk of acquiring HIV infection. In clinical trials, lenacapavir was effective for preventing HIV infection across diverse populations. Adherence to twice‑yearly injections was high. Lenacapavir was generally well tolerated. The most common adverse events were ISRs, which were mostly mild or moderate in severity. Twice-yearly lenacapavir offers practical advantages over existing PrEP options and represents a valuable addition to the HIV prevention portfolio.
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