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,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “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.”
“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,” said Peter Sands, Executive Director of the Global Fund. “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.”
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.