U.S. to Purchase 2 Million Doses of New HIV Prevention Shot for Low‑Income Countries
Doses of twice‑yearly drug lenacapvir will be bought through PEPFAR and shared with hard‑hit countries under a Gilead no‑profit agreement
The U.S. government will purchase enough doses of a new twice‑yearly HIV prevention injection to reach up to 2 million people in low‑ and middle‑income countries by 2028, the State Department announced Sept. 4, 2025.
The doses, of the drug lenacapvir, will be bought under the President's Emergency Plan for AIDS Relief, known as PEPFAR, and distributed in coordination with national governments and international partners. Gilead Sciences previously said it would make the supply available at no profit for use in countries hardest hit by HIV.
Jeremy Lewin, a senior State Department official, said the U.S. will work with governments to decide how the shots are allocated and that the immediate priority will be protecting pregnant and breastfeeding women. He said the effort will be a collaboration with the Global Fund to Fight AIDS, Tuberculosis and Malaria, another major international financier of HIV programs.
The announcement addresses a pressing question for global HIV prevention efforts after earlier cuts to U.S. foreign aid this year led to clinic closures and disruptions in testing and care in some countries. Those funding reductions had raised uncertainty over who would purchase and distribute newly available long‑acting prevention tools.
Lenacapvir is administered twice a year, offering an alternative to daily oral pre‑exposure prophylaxis, or PrEP, which has been a mainstay of HIV prevention. Public health advocates say long‑acting injectable options can overcome adherence barriers tied to daily pills, but broad access in low‑resource settings has been limited by cost and supply questions.
Gilead’s commitment to provide the drug at no profit for low‑ and middle‑income countries removed one major barrier to access. The State Department purchase under PEPFAR secures an initial supply and channels it through an established U.S. program that has funded HIV prevention, testing and treatment in dozens of countries for more than two decades.
Officials said the distribution plan will be tailored to country conditions and informed by local health systems. The U.S. purchase does not replace domestic procurement by recipient countries or other donors, but is intended to supplement efforts where need is greatest and where gaps in financing remain.
Advocates and health officials have highlighted pregnant and breastfeeding women as a focal group because of the heightened risks of HIV transmission and the potential for interventions to protect both mothers and infants. Precise roll‑out schedules, eligibility criteria and monitoring plans were not disclosed in the State Department statement and will be worked out with partner governments and the Global Fund.
The move follows broader global momentum to expand access to long‑acting HIV prevention after clinical trials showed substantial reductions in infection risk among people at high risk. Public health experts say equitable distribution will depend on coordinated procurement, supply‑chain management, training for providers, and systems to reach the populations most in need.
PEPFAR, created in 2003, has been a central U.S. vehicle for financing HIV programs abroad. The program’s recent engagement to buy and distribute lenacapvir doses signals a renewed U.S. role in securing prevention tools for low‑income countries, even as the administration and international partners continue to grapple with funding shortfalls and service disruptions in some regions.
State Department officials said additional details on allocation and country partners will be released as plans are finalized. For now, the purchase secures a supply of a long‑acting prevention option that advocates hope will help blunt new infections in settings where the HIV burden remains high.