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The Food and Drug Administration last week approved lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP) for adults and adolescents weighing at least 35 kg. The product is the first twice-a-year PrEP option available in the United States, according to a press release from manufacturer Gilead. It offers an advantage over daily oral PrEP because it requires less frequent dosing, which could lead to better adherence. Clinical trials published in The New England Journal of Medicine (Twice‑Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women and Twice‑Yearly Lenacapavir for HIV Prevention in Men and Gender‑Diverse Persons) demonstrated ≥99.9% protection with 2 injections per year. Lenacapavir has been labeled by the journal as a noteworthy breakthrough, citing its potential to reduce new HIV infections, particularly among populations facing stigma or barriers to daily medication regimens. About 36% of eligible individuals in the United States currently use PrEP, according to the manufacturer.
PrEP Choices Expand: The PrEP choices for HIV prevention in the United States include 4 options.
- emtricitabine/tenofovir disoproxil fumarate (oral, daily; approved in 2012 for PrEP)
- emtricitabine/tenofovir alafenamide (oral, daily; approved in 2019)
- cabotegravir (injectable, every 2 months after 2 initial injections; approved in 2021)
- lenacapavir (injectable, every 6 months; approved in 2025)