FDA Approves Gilead’s Twice-Yearly HIV Prevention Shot
The U.S. FDA approved Gilead Sciences’ lenacapavir, to be marketed as Yeztugo, for HIV prevention as a twice-yearly injectable (every six months) option.234
Lenacapavir is the world’s only HIV prevention shot that provides protection with just two injections per year, marking a significant advancement over current daily pills or more frequently administered shots.4
In clinical trials, lenacapavir nearly eliminated new HIV infections among people at high risk, outperforming daily oral PrEP in adherence and efficacy.4
The U.S. launch is seen as a milestone toward global rollout, potentially protecting millions, though real-world access may be affected by pricing and healthcare infrastructure challenges.14
Gilead set a U.S. list price of $28,218 per person per year, sparking calls from advocacy groups and UNAIDS for lower, more accessible pricing to ensure broader global adoption.1
The approval comes after lenacapavir received the FDA’s Breakthrough Therapy Designation and priority review status due to its potential to substantially improve HIV prevention outcomes.5
Sources:
1. https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2025/june/20250618_lenacapavir
2. https://www.statnews.com/2025/06/18/fda-approves-gilead-hiv-prevention-drug-lenacapavir-yeztugo-next-best-thing-to-vaccine/
3. https://www.biopharmadive.com/news/gilead-fda-approves-yeztugo-lenacapavir-hiv-prep/750742/
4. https://abc7.com/post/fda-approves-worlds-year-shot-prevent-hiv/16783693/
5. https://www.gilead.com/news/news-details/2025/us-fda-accepts-gileads-new-drug-applications-for-twice-yearly-lenacapavir-for-hiv-prevention-under-priority-review