Today at Salud por Derecho, we joined organizations from around the world to denounce the restrictions Gilead has imposed on the voluntary license for long-acting lenacapavir (the twice-yearly injectable PrEP). Despite recent agreements, the drug would only be available at a generic price of $40 per year in 115 low- and middle-income countries and five territories, leaving out 26 countries where HIV incidence remains very high.
This week, we learned of an agreement with two Indian generic manufacturers who will be able to produce lenacapavir starting in 2027. One of them, Dr. Reddy’s, reached this point thanks to a deal brokered by Unitaid and CHAI, which provides financial, technical, and regulatory support to accelerate access in low- and middle-income countries. At the same time, the Gates Foundation has struck another agreement with Hetero Labs.
However, these developments do not address the fundamental problem: Gilead’s license excludes much of Latin America, as well as parts of Eastern Europe, Asia, and Africa—including countries such as Argentina, Brazil, Mexico, and Peru, where pivotal clinical trials were carried out.
During the United Nations General Assembly in New York, organizations reminded the world that more than 20 million people need PrEP. Yet under Gilead’s current plan, only about 2 million people in 9 to 12 countries would gain access over the next three years. Meanwhile, in May 2025, new HIV infections surged from 3,500 to 5,800 per day after the Trump administration abandoned prevention programs—programs that continue to hold back $2.3 billion already allocated to PEPFAR for PrEP procurement.
“The agreement sets lenacapavir’s price at the same level as oral PrEP, which is excellent news. What is not acceptable is that Gilead restricts access through its license, excluding far too many people. This price should be global—affordable and available to everyone, everywhere,” said Jaime Manzano, researcher and head of policy at Salud por Derecho.
We will continue to emphasize that access to injectable PrEP cannot depend on monopolies, excessive pricing, or regulatory delays. It is urgent to ensure this tool reaches everyone who needs it—universally and affordably.
For more information, you can read the press release we published together with other organizations: Announcement $40.
