PEPFAR, Coordinated by the U.S. State Department, will Support Delivery of Lenacapavir for PrEP in High-Incidence, Resource-Limited Countries as Key Part of Strategic Efforts with Global Fund to Accelerate Access
Gilead Sciences, Inc. announced a partnership with the U.S. State Department and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) to deliver lenacapavir—Gilead's twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). This is a key component of Gilead’s larger coordinated efforts, now bringing together the resources and expertise of both PEPFAR and the Global Fund, to further advance access to lenacapavir for PrEP for up to two million people over three years in countries supported by both organizations.
The support of the U.S. State Department through PEPFAR will accelerate access to lenacapavir and move us closer to ending the HIV epidemic. Lenacapavir is one of the most important scientific breakthroughs of our time and the result of nearly two decades of work by Gilead scientists. We are providing the medicine at no profit in this partnership so we can support the U.S. government in delivering life-saving programs where the need is most urgent.
said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
This U.S. commitment exemplifies Secretary Rubio’s America First life-saving assistance agenda: it champions American innovation, advances the Administration’s goal of ending mother-to-child transmission of HIV during President Trump’s second term, and will serve as an important catalyst for greater global and private sector investment in access to this groundbreaking medication.
said Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom.
Accelerating access to innovations like lenacapavir is imperative if we are to turn the tide against HIV. In a severely resource-constrained environment, we must ensure that breakthrough tools are deployed rapidly, affordably, and in the most impactful way possible. By targeting where lenacapavir can have the greatest effect, and working with the U.S. and Gilead, we can help countries integrate it efficiently into their HIV prevention programs—reducing new infections and enabling them to move more quickly along the pathway toward transition and self-reliance.
said Peter Sands, Executive Director of the Global Fund.
This milestone marks Gilead’s latest progress in executing its ambitious access strategy to enable broad, sustainable access to lenacapavir for PrEP in primarily low- and lower-middle- income countries (LLMICs), if approved. Gilead has secured royalty-free agreements with six generic manufacturers to cover 120 high-incidence, resource-limited countries that account for a large share of the global HIV burden.
These agreements allow for the generic manufacturers to seek regulatory approvals for lenacapavir for PrEP, and provide access in sufficient volumes to meet demand and generate competition to drive down costs. By the end of 2025, Gilead intends to complete regulatory submissions for lenacapavir for PrEP in 18 countries that represent approximately 70% of the HIV burden in the region covered by the voluntary license. The company will provide Gilead-supplied product at no profit until generic manufacturers are able to fully support demand in those countries—including through its strategic partnership agreements with PEPFAR and the Global Fund to supply lenacapavir for PrEP for up to two million people.
In middle-income countries with a high burden of HIV that are not covered by Gilead’s voluntary licensing program and the agreement with the Global Fund, Gilead is pursuing multiple strategies to support access, including tiered pricing and public-private partnerships, and is working with payers to establish fast, efficient pathways to access.
Gilead continues to advance its access strategy with urgency, including:
Pursuing accelerated global regulatory pathways
Gilead is working to secure approvals in key high-incidence, resource-limited countries as quickly as possible in relation to the recent U.S. approval, European Commission marketing authorization and a positive EU-Medicines for all (EU-M4all) opinion. Gilead is following a strategic, phased approach designed to facilitate the fastest possible registration for all priority countries:
- EU-M4all: In July 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive EU-M4all opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in high-incidence, resource-limited countries.
- WHO Prequalification: Gilead submitted lenacapavir for PrEP for WHO prequalification in August 2025. WHO has announced that it expects to conclude the prequalification process by the end of 2025.
- WHO Stringent Regulatory Authority Collaborative Registration Procedure (WHO SRA CRP): Gilead will leverage the WHO SRA CRP, which uses the regulatory expertise of stringent regulatory authorities to simplify the product evaluation and approval processes for other, national regulatory authorities, helping to accelerate access to lenacapavir for PrEP.
Prioritizing timely national regulatory submissions
Now that Gilead has received a positive EU-M4all opinion for lenacapavir for PrEP, the company can pursue swift submissions to the National Regulatory Authorities in high-incidence, resource-limited countries, utilizing the EU-M4all opinion to facilitate an accelerated review timeline. The company plans to use the EU-M4all opinion as a supporting reference when submitting lenacapavir for PrEP registrations by the end of 2025 covering Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe. Gilead has already submitted a regulatory filing in South Africa.
Ensuring supply for low- and lower-middle-income countries
Gilead is actively consulting with PEPFAR and the Global Fund to understand product demand and has contracted at-risk manufacturing capacity to produce vials of lenacapavir for PrEP and corresponding oral initiation doses. Together, these steps will ensure supply of lenacapavir for PrEP to up to two million people in the countries covered by the voluntary licensing agreements until generics fully meet demand, with the ability to produce additional supply to fulfill the needs of countries and global procurers.
Extending access across more countries
Gilead is exploring options with partners, including the Pan American Health Organization (PAHO), to support countries outside the voluntary license scope.
Gilead will continue to provide updates on regulatory filings and other steps aimed at expanding access to lenacapavir for PrEP. We remain deeply engaged with stakeholders around the world, including community-based organizations, governments and multilateral organizations, to ensure that our access efforts help address the needs and preferences of the people and communities that could benefit from PrEP. Gilead is grateful to these stakeholders for their engagement and expertise, as we continue making progress toward enabling access to lenacapavir for PrEP in LMICs soon after U.S. and EU approvals.
Lenacapavir for HIV prevention is not approved by any regulatory authority outside of U.S. or EU.
There is currently no cure for HIV or AIDS.
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