CDC

CDC recommends biannual lenacapavir injections for HIV prevention

September 19, 2025

In June 2025, FDA approved injectable lenacapavir (LEN), a long-acting HIV-1 capsid inhibitor administered every six months, for HIV preexposure prophylaxis (PrEP). This recommendation is based on two randomized trials (PURPOSE 1 and PURPOSE 2), which demonstrated LEN’s efficacy in reducing HIV infection by 100% among females and 96% among a primarily male population over 52 weeks. The CDC PrEP Guidelines Work Group used the GRADE approach to assess the evidence and strongly recommends LEN for individuals weighing ≥77 lbs (≥35 kg) who would benefit from PrEP.

The most common adverse events reported were mild to moderate injection site reactions, with no significant safety concerns identified. LEN joins oral tenofovir-based regimens and injectable cabotegravir in the updated CDC PrEP guidelines. Given its biannual dosing schedule, LEN has the potential to improve adherence and persistence, addressing key barriers in current PrEP implementation and enhancing HIV prevention efforts in the U.S.

Source:

Patel RR, et al. (2025, September 18). CDC: Morbidity and Mortality Weekly Report. Clinical Recommendation for the Use of Injectable Lenacapavir as HIV Preexposure Prophylaxis — United States, 2025. https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm