FDA Approves Twice-Yearly Yeztugo for Preexposure Prophylaxis to Cut HIV Risk

FRIDAY, June 20, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor, as preexposure prophylaxis (PrEP) to reduce the risk for sexually acquired HIV.

The approval is for adults and adolescents weighing at least 35 kg and is the first and only twice-yearly option available in the United States for PrEP. Individuals must have a negative HIV-1 test prior to starting Yeztugo.

Data from two phase 3 trials, PURPOSE 1 and PURPOSE 2, supported the approval. In the PURPOSE 1 trial, data showed twice-yearly subcutaneous Yeztugo was associated with zero HIV infections among 2,134 participants in the Yeztugo group, representing a 100 percent reduction in HIV infections. It also showed superior prevention of HIV infections versus 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 subcutaneous Yeztugo group, which was also superior for prevention of HIV infections versus once-daily oral Truvada among a geographically diverse cohort of cisgender men and gender-diverse people.

In both trials, Yeztugo was superior for prevention of HIV infections versus background HIV incidence and was generally well tolerated, with no significant or new safety concerns.

“Yeztugo could be the transformative PrEP option we’ve been waiting for — offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” Carlos del Rio, M.D., from Emory University and the Emory Center for AIDS Research in Atlanta, said in a statement. “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face.”

Approval of Yeztugo was granted to Gilead Sciences.

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