A new long-acting preventive drug for HIV could be made available to the world’s poorest countries by the end of 2025 or early 2026, a global health official told Reuters on Tuesday .
The ambition is to begin deliveries of Gilead Sciences’ lenacapavir by that date, said Hui Yang, head of procurement operations at the Global Fund to Fight AIDS, Tuberculosis and Malaria. She said, however, that many things need to happen first, including approval of the injectable drug by authorities such as the US Food and Drug Administration (FDA) and the World Health Organization (WHO). .
Lenacapavir is already approved for the treatment of multidrug-resistant HIV and costs approximately $42,250 for the first year of treatment in the United States. Clinical trials this year showed it was also very effective in preventing infection and Gilead is seeking approvals for this new use globally.
“We don’t want low-income and lower-middle-income countries to wait, to be at the back of the line” when these authorizations are granted, Ms. Yang said, an equality issue that has hampered the fighting HIV for decades.
To prevent that, the Global Fund said Tuesday it would join forces with the President’s Emergency Plan for AIDS Relief (PEPFAR), with funding from the Global Fund Foundation for Children and the Bill and Melinda Gates Foundation, to support affordable access to the expensive medicine in the countries they work with “from day one”.
The groups did not provide further details on how this might work, other than saying they aim to reach at least two million people over three years.
Last October, Gilead signed agreements with six generic drugmakers to manufacture and sell lenacapavir at lower costs in 120 low- and middle-income countries. This initiative was criticized because it left out certain countries, particularly in Latin America.
No deals have yet been signed with Gilead or any of these generic makers, Mr. Yang said, but the company will work with all relevant companies.
Gilead Sciences did not immediately respond to a request for comment.
