PEPFAR Release
September 4, 2025
Today, the U.S. Department of State announced a market-shaping initiative by the President’s Emergency Plan for AIDS Relief (PEPFAR) to bring U.S.-based Gilead Sciences’ breakthrough drug lenacapavir to market in high-burden HIV countries. The initiative – which will promote global scale in production and distribution of the medication and catalyze further global investment – has the potential to save hundreds of thousands of lives.
Lenacapvir is a twice-yearly injectable drug. In Gilead’s clinical trials, more than 99% of people 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.
“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.
Lenacapavir’s twice per year delivery method increases convenience and adherence, ensuring that fewer cases of HIV are transmitted and reducing treatment costs. The U.S. Department of State will be partnering with countries with the largest HIV/AIDS epidemics over the coming months to co-develop strategies for distributing lenacapavir, with a focus on preventing mother-to-child transmission.
Gilead is offering this product to PEPFAR and the Global Fund at cost and without a profit. “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.”
The Global Fund is also co-funding this initiative to provide lenacapavir in additional countries. “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. “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.”