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Lenacapavir in Eswatini and Zambia: Global Health Through American Innovation

Driving Global Health Progress Through American Innovation and Burden Sharing: The First Doses of Lenacapavir Arrive in Eswatini and Zambia



By Africa-Related, New York

Lenacapavir arrives in Eswatini and Zambia: Global Health Progress Through American Innovation and Burden Sharing. Photo: Mufid Majnun @mufidpwt

PEPFAR Release
November 18, 2025

 Full Video

Today, the United States is announcing the delivery of the first doses of lenacapavir, an innovative drug produced by American company Gilead Sciences to help prevent the spread of HIV. The doses arriving in Eswatini and Zambia are part of a market-shaping initiative by the President’s Emergency Plan for AIDS Relief (PEPFAR) to rapidly bring lenacapavir to market in ten high-burden HIV countries.

First announced on September 4, 2025, this landmark partnership between the Department of State, Gilead Sciences, and the Global Fund to Fight HIV, Tuberculosis and Malaria (“Global Fund”) is providing at least 2 million doses, at cost, to targeted populations in high-burden HIV countries. This catalytic investment is aimed at backstopping manufacturing capacity and stimulating local demand for this innovative medication.  

U.S. officials are on site today as the first lenacapavir doses are being delivered in Eswatini and Zambia. Given strong demand and progress in scaling manufacturing, we expect to surpass the 2 million dose commitment by the targeted delivery date in 2028.

Under the Trump Administration, the U.S. Food and Drug Administration (FDA) approved lenacapavir on June 18, 2025 for the prevention of HIV and is now delivering the doses in high-burden countries following the partnership announced in September between the Department of State, Gilead Sciences, and the Global Fund — just five months after FDA approval, a new standard for global and developing world access to innovative therapies.

Lenacapavir is a twice-yearly injectable drug in which more than 99 percent of people in clinical trials remained HIV negative. The drug has the potential to be particularly helpful for pregnant and breastfeeding mothers as it safely protects them during and after pregnancy to prevent mother-to-child transmission. The Department expects lenacapavir to be an important tool in achieving the Administration’s goal of ending mother-to-child transmission of HIV during President Trump’s second term.

In our new America First Global Health Strategy, the Department of State is establishing a first-of-its-kind innovation fund to support American-led research, market-shaping and other dynamic 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.

Further information about this and other global health security initiatives are outlined in the America First Global Health Strategy.

 

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See full press briefing transcript here




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