Gilead Partners With PEPFAR to Expand Access to Twice-Yearly Lenacapavir for HIV Prevention in Low- and Middle-Income Countries
Gilead Sciences, has announced a landmark partnership with the U.S. Department of State and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to accelerate global access to lenacapavir, its long-acting, twice-yearly injectable HIV-1 capsid inhibitor. This collaboration is aimed at delivering pre-exposure prophylaxis (PrEP) to as many as two million people over the next three years, primarily in low- and lower-middle-income countries (LLMICs) where the burden of HIV remains high.
The agreement reflects a broader coordinated effort that brings together Gilead, PEPFAR, and the Global Fund, each leveraging resources and expertise to make lenacapavir available to communities most affected by HIV. It also underscores Gilead’s commitment to making the therapy available at no profit under this initiative, demonstrating the company’s pledge to prioritize public health impact over commercial gain in this area.
A Milestone in HIV Prevention Efforts
The HIV epidemic continues to disproportionately affect populations in resource-limited countries, particularly in sub-Saharan Africa and parts of Asia. Current PrEP regimens, which often require daily oral dosing, can pose challenges related to adherence and accessibility. Lenacapavir offers a significant scientific advance—a twice-yearly injection that provides durable protection against HIV infection.
Daniel O’Day, Chairman and CEO of Gilead Sciences, described the partnership as pivotal to advancing global HIV prevention goals:
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.
The collaboration builds upon recent progress, with the Global Fund and Gilead already aligning strategies to deploy lenacapavir for prevention in high-incidence countries.
U.S. Government Endorsement and Global Significance
The initiative has drawn strong backing from U.S. officials, who emphasize its alignment with foreign assistance priorities and long-term goals for global HIV response. Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom, framed the agreement within the broader U.S. commitment to public health and innovation:
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.
For the Global Fund, which supports HIV programs across more than 100 countries, the partnership is equally significant. Peter Sands, Executive Director of the Global Fund, noted the urgency of introducing effective innovations like lenacapavir into HIV prevention programs
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.
Expanding Access Through Licensing and Partnerships
A critical component of Gilead’s access strategy involves voluntary licensing agreements with six generic manufacturers. These agreements cover 120 high-incidence, resource-limited countries—representing the bulk of the global HIV burden. Generic manufacturers are empowered to seek regulatory approvals, supply sufficient volumes, and stimulate market competition to reduce costs.
Until generic manufacturers can fully supply local demand, Gilead will provide lenacapavir at no profit under its agreements with PEPFAR and the Global Fund. The company intends to complete regulatory submissions by the end of 2025 in 18 countries, including South Africa, Kenya, Nigeria, Ethiopia, and others, which together account for approximately 70% of the HIV burden in regions covered by the voluntary license.
In addition to LLMICs, Gilead is working to support access in middle-income countries with a high HIV prevalence but not covered by the voluntary license. Here, strategies include tiered pricing, public-private partnerships, and collaboration with national payers to establish efficient access pathways.
Regulatory Pathways to Speed Access
Gilead is pursuing a multi-pronged global regulatory strategy to enable the swift approval and distribution of lenacapavir:
- EU-M4all Opinion: In July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive EU-M4all opinion for lenacapavir as PrEP. This supports streamlined regulatory reviews in high-incidence, resource-limited countries and opens the door to World Health Organization (WHO) prequalification.
- WHO Prequalification: In August 2025, Gilead submitted lenacapavir for WHO prequalification, which is expected to be completed by the end of the year. Prequalification is a critical step in enabling procurement by global health agencies.
- WHO Stringent Regulatory Authority Collaborative Registration Procedure (SRA CRP): Gilead will leverage this mechanism, which relies on prior assessments from stringent regulators, to accelerate approval timelines in other countries.
- National Submissions: Building on the EU-M4all opinion, Gilead plans to submit applications to regulatory authorities in multiple African and Asian countries by late 2025. These include Botswana, Eswatini, Kenya, Malawi, Mozambique, Nigeria, Rwanda, Tanzania, Uganda, Vietnam, and Zimbabwe, among others.
Through these regulatory pathways, Gilead aims to ensure rapid approval and early integration of lenacapavir into national HIV prevention programs.
Ensuring Reliable Supply
To meet anticipated demand, Gilead has contracted at-risk manufacturing capacity to produce lenacapavir vials and corresponding oral initiation doses. The company is working closely with PEPFAR and the Global Fund to forecast demand and align supply. This approach is designed to guarantee access for up to two million people covered under the agreement until generics can assume full supply responsibilities.
Beyond the scope of the voluntary license, Gilead is also in discussions with organizations such as the Pan American Health Organization (PAHO) to explore additional opportunities for extending access.
Progress in the United States
While the focus of this partnership is on LLMICs, Gilead continues to expand access to lenacapavir in the U.S., where it is marketed as Yeztugo® for PrEP. The company is working closely with insurers and healthcare systems to ensure broad coverage. For commercially insured individuals, Gilead’s Advancing Access® Co-Pay Savings Program can reduce out-of-pocket costs to as little as zero dollars.
For uninsured patients who meet eligibility criteria, the company’s medication assistance program provides Yeztugo at no cost. This dual focus—global and domestic—reflects Gilead’s comprehensive strategy to maximize the impact of lenacapavir across diverse healthcare settings.
