FDA

FDA greenlights first twice-yearly injection for HIV prevention

June 20, 2025

Brand name: Yeztugo

Generic name: lenacapavir

Manufacturer: Gilead Sciences

Approval date: June 18, 2025

FDA approved Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing ≥35kg who are at increased risk for disease. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.

Lenacapravir is also approved for HIV treatment under the brand name Sunlenca.

Efficacy

Approval was supported by data from the phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials. In the PURPOSE 1 trial, data at the primary analysis showed twice-yearly SC Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections, and superiority of prevention of HIV infections vs. once-daily oral Truvada in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial, there were two HIV infections among 2,179 participants in the twice-yearly SC Yeztugo group, showing 99.9% of participants in the Yeztugo group didn’t acquire HIV infection and superiority of prevention of HIV infections vs. once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections compared with background HIV incidence and was generally well-tolerated, with no significant or new safety concerns identified.

Safety

Most common adverse reactions (≥5%, all grades) in clinical trials were injection site reactions, headache, and nausea. The Prescribing Information includes a Boxed Warning about the risk of drug resistance with use of Yeztugo for HIV-1 PrEP in undiagnosed HIV-1 infection.

Sources:

Yeztugo (lenacapavir) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220020s000lbl.pdf Revised June 2025. Accessed June 19, 2025.

Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. [News release]. 2025. https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection