The U.S. Department of State, Gilead Sciences, and the Global Fund to Fight AIDS, Tuberculosis and Malaria have announced the launch of a large-scale initiative to expand access to lenacapavir — the first injectable HIV prevention medication administered just twice a year.

The announcement was made during an official briefing at the U.S. Department of State, held as a public press conference with participation from government, business, and global partners. Speakers included Jeremy Lewin, Senior Official for Humanitarian Affairs at the State Department, Daniel O’Day, Chairman and CEO of Gilead Sciences, and Peter Sands, Executive Director of the Global Fund.

As part of the new initiative, the goal is to provide access to lenacapavir for two million people over the next three years in countries with a high burden of HIV. The medication will be supplied at cost, with no profit to Gilead, and part of the expenses will be covered by the U.S. government through the PEPFAR program. Special focus will be placed on preventing mother-to-child transmission of HIV — thanks to lenacapavir’s biannual dosing schedule, it can provide protection throughout the entire period of pregnancy and breastfeeding. Although the full list of participating countries has not yet been released, it is known that 8–12 priority countries are involved, and first shipments are expected before the end of 2025.

However, the initiative has been met with criticism from some NGOs and activists. Health GAP, for example, stated that the actual scale of the program is much smaller than it appears. They argue that the U.S. government continues to block significant funds needed for PEPFAR to function effectively, and that the promised annual coverage — about 667,000 people — is already included in the Global Fund’s current commitments, meaning it is not an added contribution. Activists have also raised concerns that access to lenacapavir will remain limited and may not reach everyone in need.

Additional criticism has been directed at the program’s implementation model, which largely excludes nonprofit organizations — many of which have deep experience working with key populations. Experts warn that without their involvement, the initiative risks being less effective and may fail to reach the most vulnerable communities.