PEPFAR and Gilead Partner to Deliver Twice-Yearly Lenacapavir for HIV Prevention

The US President’s Emergency Plan for AIDS Relief (PEPFAR), coordinated by the US State Department, has partnered with Gilead Sciences to deliver lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), to up to 2 million people in primarily low- and lower-middle-income countries (LLMICs) over the next three years.¹

The collaboration builds on prior agreements with the Global Fund and other multilateral organizations, aiming to accelerate equitable access in high-incidence, resource-limited settings. Gilead will provide lenacapavir at no profit until licensed generic manufacturers are able to fully meet demand.¹

Lenacapavir, the first long-acting twice-yearly PrEP option, is currently approved in the United States and European Union, with regulatory submissions in 18 priority countries expected by the end of 2025. The World Health Organization (WHO) prequalification process is underway, supported by the European Medicines Agency’s EU-M4all opinion, which expedites evaluations in resource-limited settings.¹

The therapy is administered as a subcutaneous injection every six months following an oral lead-in dose. As a capsid inhibitor, lenacapavir targets multiple stages of the HIV replication cycle. Clinical trials have demonstrated its efficacy for both HIV prevention and the treatment of multidrug-resistant HIV.¹

US government officials underscored the partnership as part of broader efforts to accelerate epidemic control, while Global Fund leadership emphasized the importance of rapid and affordable deployment of long-acting prevention options in high-burden populations.¹

Background News

June 18, 2025 – FDA Approval
The FDA approved lenacapavir (Yeztugo), the first and only twice-yearly injectable PrEP option, supported by the phase 3 PURPOSE 1 and PURPOSE 2 trials. These trials demonstrated 96% to 100% efficacy in preventing HIV across diverse populations. In an interview with Contagion, Jared Baeten, MD, PhD, senior vice president of clinical development and virology at Gilead Sciences, highlighted lenacapavir’s potential to overcome adherence and stigma barriers associated with daily oral PrEP.²

Listen to our full interview from the approval: FDA Approves Gilead’s Twice-Yearly Injectable Lenacapavir (Yeztugo) for HIV Prevention

July 9, 2025 – Global Fund Partnership
Gilead announced a three-year partnership with the Global Fund to provide up to 2 million doses of lenacapavir at no profit in LLMICs. This agreement was designed to bridge access until generic manufacturers under voluntary licensing arrangements could meet demand across 120 high-incidence countries. Distribution will be prioritized according to national HIV prevention strategies, while Gilead has contracted at-risk manufacturing capacity to ensure supply.³

July 25, 2025 – EMA Positive Opinion
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending lenacapavir (Yeztugo) for PrEP in adults and adolescents at increased risk of HIV-1. The accelerated review positions the drug for European Commission approval later this year, extending market exclusivity and enabling rollout across all 27 EU member states plus Norway, Iceland, and Liechtenstein. PURPOSE trials demonstrated 99.9–100% efficacy, and the CHMP also endorsed the EU-M4all pathway to streamline WHO prequalification and access in resource-limited countries.⁴

References

1.Gilead Sciences. Gilead announces partnership with PEPFAR to deliver twice-yearly lenacapavir for HIV prevention. Business Wire. Published September 4, 2025. Accessed September 6, 2025. https://www.gilead.com/news/news-details/2025/gilead-announces-partnership-with-pepfar-to-deliver-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low--and-lower-middle-income-countries

2. Gilead. Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. June 18, 2025. Accessed June 18, 2025. https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection

3.Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low and Lower Middle Income Countries. Gilead.com. Published 2025. Accessed July 9, 2025. https://www.gilead.com/news/news-details/2025/gilead-finalizes-agreement-with-the-global-fund-to-accelerate-access-to-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low--and-lower-middle-income-countries

4.Gilead. Gilead receives positive CHMP opinions under accelerated review from European Medicines Agency for twice-yearly lenacapavir for HIV prevention [news release]. Gilead Sciences. July 25, 2025. Accessed September 6, 2025. https://www.gilead.com/news/news-details/2025/gilead-receives-positive-chmp-opinions-under-accelerated-review-from-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention