On July 9, 2025, Gilead Sciences, Inc announced a strategic partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply up to 2 million people in low and lower-middle income countries (LLMICs) with yeztugo, (lenacapavir) a long-acting injectable for HIV pre-exposure prophylaxis (PrEP). Under the agreement, Gilead will provide lenacapavir at no profit over a three-year period, supporting access until licensed generic versions are available and can meet demand in the targeted regions.1
“This agreement is based on our shared intention to benefit as many people as possible, as quickly as possible with this breakthrough in HIV prevention,” said Daniel O’Day, Chairman and chief executive officer at Gilead Sciences in the press release. “We are providing the medicine at no profit to Gilead, and in enough supply to reach up to two million people in low- and lower-middle-income countries ahead of generic lenacapavir becoming available.”1
Lenacapavir, a capsid inhibitor given biannually, is meant to prevent HIV-1 by disrupting the virus at various stages of its replication cycle. Gilead’s agreement with the Global Fund proceeds the company’s October 2024 commitment to voluntary licensing, in which it authorized the manufacture and supply of lenacapavir in 120 high-incidence, resource-limited countries through royalty-free, non-exclusive licenses. Until those generics become available, this direct supply model will help accelerate access to the branded product.1
The Global Fund will prioritize countries eligible for the agreement based on national HIV prevention strategies, current epidemiology, and logistical readiness. Gilead is contracting at-risk manufacturing capacity to support demand for up to 2 million people, including oral initiation doses and injection vials.1
“This is not just a scientific breakthrough—it’s a game-changer for HIV/AIDS,” said Peter Sands, executive director of the Global Fund. “For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic—but only if we get it to the people who need it most.”1
In February 2025, the European Medicines Agency validated Gilead’s submission for lenacapavir PrEP under the EU-Medicines for all (EU-M4all) procedure. This pathway allows regulatory authorities in eligible LLMICs to reference the EMA’s assessment to expedite their own national review processes.1
What You Need To Know
Gilead will provide up to 2 million doses of lenacapavir for HIV prevention at no profit through a partnership with the Global Fund, targeting low- and lower-middle-income countries
Lenacapavir is a long-acting, twice-yearly injectable PrEP option that showed near-perfect efficacy in phase 3 trials, offering a major advance over daily oral regimens.
The initiative aims to overcome key barriers to PrEP access, like adherence challenges and limited infrastructure, by delivering a more scalable and discreet prevention option.
In June 2025, lenacapavir’s US FDA approval was backed by strong phase 3 data from Gilead’s PURPOSE 1 and PURPOSE 2 trials and represents a significant step forward in addressing persistent issues related to adherence with daily oral PrEP. Clinical trial results demonstrate lenacapavir’s high efficacy in HIV prevention. In PURPOSE 1, no HIV infections occurred among 2,134 cisgender women in South Africa and Uganda, indicating 100% risk reduction. PURPOSE 2 showed a 96% risk reduction among cisgender men and gender-diverse individuals, with nearly all participants remaining HIV-free during the study.2
Gilead emphasized their collaboration with international aid organizations to assess demand and distribution in partnership with local healthcare systems. In middle-income countries that are not covered by the Global Fund agreement or voluntary licensing program, Gilead is continuing to pursue access strategies, including tiered pricing and public-private partnerships.1
PrEP remains underutilized, with significant access gaps from cost, coverage limitations, and disparities affecting marginalized communities. Long-acting lenacapavir may help to close this gap by easing adherence and reducing clinic visits. Globally, its twice-yearly dosing is especially promising for low-income countries, where infrastructure challenges have limited access oral PrEP. Gilead’s partnership with the Global Fund could significantly expand access and advance global HIV prevention efforts.3
This partnership between Gilead and the Global Fund could be a key milestone in global HIV prevention. The initiative hopes to bring a highly effective biomedical prevention option to populations with historically limited access to innovation. Collaboration, funding, and infrastructure support will be crucial in ensuring the successful execution and achieving significant reductions in HIV infections worldwide.1
References
1.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
2. Abene S, Baeten J. FDA Approves Gilead’s Twice-Yearly Injectable Lenacapavir (Yeztugo) for HIV Prevention. ContagionLive. Published June 18, 2025. Accessed July 9, 2025. https://www.contagionlive.com/view/fda-approves-gilead-s-twice-yearly-injectable-lenacapavir-for-hiv-prevention
3. Siegler A, Sullivan P. The PrEP Laboratory Service Gap: Applying Implementation Science Strategies to Bring PrEP Coverage to Scale in the United States. Journal of Law, Medicine & Ethics. 2022;50(S1):40-46. doi:https://doi.org/10.1017/jme.2022.34
