Yeztugo Approval: Twice-Yearly HIV PrEP Explained
Yeztugo is injectable lenacapavir approved in June 2025 as an HIV pre-exposure prophylaxis option for eligible adults and adolescents weighing at least 35 kilograms.
Timeline
- June 18, 2025: The FDA approved Yeztugo for HIV-1 pre-exposure prophylaxis.
- September 18, 2025: CDC published its strong recommendation for lenacapavir as a PrEP option.
The U.S. Food and Drug Administration approved Yeztugo, a brand of lenacapavir, on June 18, 2025 for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1. The approved population includes adults and adolescents weighing at least 35 kilograms, or 77 pounds, who are at risk of acquiring HIV. [1][2]
PrEP means medication taken before a possible exposure to lower the chance of acquiring HIV. Yeztugo is not an HIV vaccine and is not a complete treatment regimen for someone who already has HIV. Lenacapavir blocks the HIV-1 capsid at multiple stages of the viral life cycle. [1][2]
The maintenance schedule uses subcutaneous injections every six months. Starting the regimen also involves oral loading doses and two injections administered in immediate sequence on the first day. “Twice yearly” describes the continuing injection interval; it should not be read as the entire initiation protocol or permission to skip scheduled clinical visits. [1][2]
HIV testing is essential before the first dose and around later injections. The prescribing information carries a boxed warning about drug resistance if Yeztugo is used by someone with undiagnosed HIV-1. CDC recommends laboratory antigen-and-antibody testing and provides additional guidance for identifying possible acute infection. [1][2]
CDC strongly recommends six-monthly lenacapavir as a PrEP option for eligible people who would benefit from prevention, based on high-certainty evidence. Product choice remains individual. Daily oral PrEP and another injectable regimen remain options, and preferences, access, interactions, health history and ability to return for injections can affect the decision. [1]
Injection-site reactions are common and can include pain, firmness and subcutaneous nodules. Because lenacapavir forms a drug depot under the skin and remains in the body for an extended period, stopping injections requires a plan for continued HIV prevention during the drug’s long pharmacologic tail when exposure risk continues. [1][2]
Approval establishes the labeled use in the United States; it does not mean every person needs PrEP or that one regimen is best for everyone. A clinician must confirm HIV-negative status, review potential drug interactions and discuss follow-up. Barrier methods and other evidence-based measures can remain part of a broader prevention strategy. [1][2]