Everything to know about Yeztugo: FDA approves Gilead's twice-yearly HIV prevention injection
Marking a major leap in the global effort to end the HIV epidemic, the U.S. Food and Drug Administration (FDA) has approved Yeztugo, a revolutionary twice-yearly injection from Gilead Sciences that prevents HIV. Designed for pre-exposure prophylaxis (PrEP), Yeztugo—scientifically known as lenacapavir—is now the most infrequent dosing option available, offering unmatched convenience and efficacy.
Lenacapavir is already sold as a treatment for H.I.V. infections that are resistant to other medications.
Nardus Engelbrecht/Associated Press
Clinical trials showed that Yeztugo virtually eliminated new infections among at-risk individuals. It significantly outperformed existing HIV prevention methods, including daily oral PrEP pills like Truvada and Descovy, and GSK’s Apretude injection, which is administered every two months after initial doses.
“This really will bend the arc of the epidemic,” said Gilead CEO Daniel O’Day, emphasizing the injection's potential to transform global public health.
Proven Efficacy and Simplicity
In two pivotal studies:
• 99.9% efficacy was recorded in a trial involving cisgender men, transgender women, transgender men, and nonbinary individuals—only 2 infections occurred out of over 2,000 participants.
• A separate trial among cisgender women showed 100% protection, with no infections reported.
These results represent a 96% risk reduction, making Yeztugo one of the most effective HIV prevention options to date.
Cost, Coverage & Access
Yeztugo's annual list price is $28,218—comparable to other PrEP medications. Truvada and Descovy cost around $24,000 annually without insurance, while Apretude can cost up to $4,000 per dose.
Gilead has committed to ensuring access through:
• Broad insurance coverage
• Copay savings programs reducing out-of-pocket costs to $0 for eligible patients
• Free drug programs for uninsured individuals
• Licensing deals with six generic manufacturers for low-cost versions in 120 low- and middle-income countries
• No-profit global supply for 2 million doses until generics are available
Addressing Disparities and HIV Stigma
HIV continues to hit marginalized communities hardest. In the U.S.:
• Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users.
• Hispanic Americans make up 31% of new cases but just 18% of users.
Daily pill regimens often fail due to stigma, daily adherence challenges, or lack of awareness. A discreet, long-acting injectable like Yeztugo removes those barriers.
“Getting a twice-a-year injection really gives you that privacy that people have been looking for,” said Gilead CCO Johanna Mercier.
Funding and Policy Challenges Ahead
Despite the medical breakthrough, Yeztugo’s real-world impact may be constrained by political factors. The Trump-aligned GOP budget proposal for 2026 includes deep cuts to Medicaid and CDC-run HIV prevention programs, threatening access to PrEP for underserved populations.
Medicaid covers around 40% of nonelderly adults with HIV in the U.S., making these programs essential for equitable rollout.
“The entire foundation for HIV prevention in America is under attack,” warned Jeremiah Johnson, executive director of PrEP4All.
If proposed cuts proceed, experts fear a reversal of progress—especially for those already using PrEP.
Key Takeaways
• Yeztugo is the first FDA-approved HIV prevention injection taken every six months.
• Demonstrated up to 100% efficacy in trials.
• Could drastically improve PrEP access and adherence, particularly in marginalized communities.
• Faces hurdles from insurance coverage gaps and proposed federal funding cuts.
• Gilead plans to scale access globally, including through generic manufacturing and no-cost supply programs.
Yeztugo represents a powerful new tool in the fight against HIV—if health systems, insurers, and governments can ensure it reaches the people who need it most.
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