The United States has begun delivering the first doses of lenacapavir, an innovative HIV-prevention drug developed by Gilead Sciences, to Eswatini and Zambia. The rollout is part of a PEPFAR-led market-shaping initiative aimed at accelerating access to lenacapavir across ten high-burden HIV countries.
Announced on September 4, 2025, the partnership between the U.S. Department of State, Gilead Sciences, and the Global Fund to Fight HIV, Tuberculosis and Malaria (“Global Fund”) committed to supplying at least 2 million doses at cost to priority populations. The investment is designed to bolster manufacturing capacity and spark local adoption of the new injectable therapy.
U.S. officials are overseeing the first deliveries in Eswatini and Zambia, with expectations of exceeding the 2 million–dose target before the 2028 deadline due to strong country demand and rapid manufacturing scale-up.
Lenacapavir received FDA approval for HIV prevention on June 18, 2025, under the Trump Administration. The drug is now being deployed in high-burden countries just five months after approval—an accelerated timeline that the partners say sets “a new standard for global and developing world access to innovative therapies.”
The twice-yearly injectable has shown robust results in clinical trials, with more than 99 percent of participants remaining HIV negative. It is expected to be particularly beneficial for pregnant and breastfeeding women by reducing the risk of mother-to-child transmission. The Department of State anticipates that lenacapavir will play a key role in the Administration’s goal of ending mother-to-child HIV transmission during President Trump’s second term.
As part of its new America First Global Health Strategy, the Department of State is also establishing an innovation fund to support U.S.-led research, market-shaping efforts, and other advancements in global health.
“Through our America First Global Health Strategy, the Trump Administration is making targeted and high-impact investments in breakthrough health innovations like lenacapavir that will bend the curve of the HIV epidemic and help countries globally to break away from reliance on external health assistance,” said Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs and Religious Freedom. “The United States is proud to champion this American biomedical achievement and, along with the Global Fund, to provide a catalytic investment to facilitate broad adoption globally.”
“The Global Fund is proud to see countries gaining first-hand experience with a product that represents a new era in HIV prevention. The real results will come from rapidly reaching individuals at high risk for new HIV acquisition and at scale. If communities are at the center, innovation turns into lasting progress, and that progress becomes sustainable,” said Peter Sands, Executive Director of the Global Fund.
“The arrivals of the first doses of lenacapavir in Eswatini and Zambia mark an important milestone in HIV prevention and reflect our commitment to supporting communities with the greatest need. For the first time, a new HIV medicine is reaching communities in sub-Saharan Africa in the same year as its U.S. approval,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
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