The U.S. Department of State has announced a new initiative by the President’s Emergency Plan for AIDS Relief (PEPFAR) to introduce lenacapavir, a drug developed by Gilead Sciences, into high-burden HIV countries. This move aims to scale up production and distribution of the medication and attract additional global investment.
Lenacapavir is an injectable medication administered twice yearly. According to Gilead’s clinical trials, over 99% of participants remained HIV negative while using the drug. It is expected to be especially beneficial for pregnant and breastfeeding mothers by providing protection against mother-to-child transmission of HIV during and after pregnancy.
“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.
The twice-yearly dosing schedule of lenacapavir is intended to improve convenience and adherence among patients. The Department of State plans to work with countries most affected by HIV/AIDS in the coming months to develop strategies focused on preventing mother-to-child transmission through distribution of the drug.
Gilead Sciences will offer lenacapavir at cost without profit to PEPFAR and the Global Fund. “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 will also co-fund this initiative 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.”
