Approval marks first and only twice-yearly option available in the United States for PrEP<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
“Yeztugo could be the transformative PrEP option we\u2019ve 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.”<\/p>\n
Approval of Yeztugo was granted to Gilead Sciences.<\/p>\n