FDA Approval of Injectable Lenacapavir Marks Major Milestone in HIV Prevention

The FDA approval of injectable lenacapavir in June 2025—marketed as Yeztugo—has been hailed as a transformative moment in HIV prevention. This twice-yearly, long-acting injectable PrEP (pre-exposure prophylaxis) offers near-complete protection, reshaping public health strategies globally.

What Is Lenacapavir?

• Lenacapavir is a first-in-class HIV‑1 capsid inhibitor developed by Gilead Sciences. It disrupts critical viral functions, offering robust preventive efficacy when used as PrEP.
• Administered via injection twice yearly, lenacapavir eliminates the burden of daily oral pills, benefiting those facing adherence challenges, stigma, or limited access to healthcare.

Clinical Trial Results

• In the Phase 3 PURPOSE 1 and PURPOSE 2 studies, lenacapavir showed ≥99.9% effectiveness, with zero new infections in women and nearly complete protection in men and gender‑diverse groups.

Global Health Impact

• Recognized as Science magazine’s 2024 Breakthrough of the Year, the injectable presents a major leap in HIV prevention efforts.
• WHO has quickly recommended lenacapavir at the IAS 2025 conference, citing it as “the closest option to an HIV vaccine.” It complements existing PrEP methods, including daily pills and the dapivirine ring.
• Gilead and partners aim to license generics for ~120 low-income nations, potentially supplying 2 million users over three years once WHO prequalification is complete.

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Accessibility, Costs & Challenges

• The list price in the U.S. exceeds $28,000 per year, with assistance programs expected to alleviate financial burden.
• Experts emphasize affordability as a key facilitator of uptake: “It’s going to be hard… with the finances… That’s going to be the biggest problem to getting this drug going.”

What’s Next?

• WHO guidelines for lenacapavir roll-out were introduced July 14, 2025, advocating integration into national HIV prevention programs with simplified rapid testing.
• Global collaborations—Global Fund, PEPFAR, CIFF, and Gilead—aim to accelerate access and generic production for low‑ and middle‑income countries.

Why It Matters

• User-Friendly Prevention: Two injections per year could dramatically improve adherence over daily pills.
• High Efficacy: Phase 3 trials confirm nearly 100% protection.
• Equity Potential: Generic licensing and public health guidelines could bring global PrEP coverage to new heights—if affordability and distribution challenges are addressed.

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