Lenacapavir HIV drug could reach low-income nations by 2025-2026

A new long-acting preventive HIV drug, lenacapavir, could be available 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.

According to Hui Yang of the Global Fund, lenacapavir, a new long-acting preventive HIV drug, may be available in the world’s poorest countries by late 2025 or early 2026.

The timeline depends on regulatory approvals from authorities like the U.S. Food and Drug Administration and the World Health Organization, Yang said.

Lenacapavir is already approved as a treatment for multi-drug resistant HIV in the U.S., where it costs around $42,250 for the first year of therapy. Recent clinical trials have also demonstrated its effectiveness in preventing HIV infection, prompting Gilead Sciences to seek global approval for this new use.

Yang stressed the need for low and middle-income countries to have timely access to the drug, stating, "We don't want...low and low-middle income countries to wait, to be at the back of the line." This issue has long been a barrier in the fight against HIV.

To ensure affordable access, the Global Fund is collaborating with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), along with funding from the Children’s Investment Fund Foundation and the Bill & Melinda Gates Foundation. Together, they aim to provide lenacapavir to at least two million people in participating countries over three years.

In October, Gilead signed agreements with six generic drugmakers to produce lenacapavir more affordably for 120 low and middle-income countries. However, the deal faced criticism for excluding some regions, particularly in Latin America. Yang stated that while no agreements have been finalized with Gilead or the generic producers, they will work with all involved companies.