New HIV prevention drug set for global rollout by 2026
A new long-acting preventive HIV drug, lenacapavir, could be introduced in the world’s poorest countries by late 2025 or early 2026, according to Hui Yang, head of supply operations at the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
Lenacapavir, developed by Gilead Sciences, is already approved in the United States for treating multi-drug-resistant HIV, with a steep price tag of $42,250 for the first year.
However, recent clinical trials have demonstrated its effectiveness in preventing HIV infection, prompting Gilead to seek global regulatory approvals for the expanded use, including from the U.S. FDA and the World Health Organization.
To ensure equitable access and prevent low and middle-income countries from falling to the “back of the line,” as has often been the case, the Global Fund has partnered with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Children’s Investment Fund Foundation, and the Bill and Melinda Gates Foundation.
Together, they aim to provide affordable access to the drug and target reaching at least two million people over three years.
In October, Gilead signed agreements with six generic drug manufacturers to produce and sell lenacapavir at reduced costs across 120 low- and middle-income countries.
However, the deal drew criticism for excluding some nations, particularly in Latin America. Hui Yang noted that while no agreement with Gilead or the generic producers has been finalized, the Global Fund plans to collaborate with all involved to secure access.
The introduction of the injectable drug could be a game-changer in HIV prevention, offering long-term protection and helping to address global health inequities in the fight against HIV/AIDS.
Reuters
