New HIV Prevention Drug May Reach Poorest Nations by 2025

A groundbreaking long-acting HIV prevention drug, lenacapavir, could become 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.

Yang emphasized that key regulatory approvals, including those from the U.S. FDA and the World Health Organization, must be secured before the injectable drug can be distributed.

Lenacapavir, developed by Gilead Sciences, is already used to treat multi-drug-resistant HIV, costing around $42,250 per year in the United States. Recent clinical trials, however, showed its effectiveness in preventing HIV infection, prompting Gilead to seek global approval for this additional use.

"We don't want...low and low-middle income countries to wait, to be at the back of the line," Yang said, addressing long-standing inequalities in global HIV treatment access.

To ensure early access, the Global Fund, PEPFAR, the Children’s Investment Fund Foundation, and the Bill and Melinda Gates Foundation are collaborating to make the drug affordable. The initiative aims to reach two million people within three years.

In October, Gilead partnered with six generic drugmakers to produce lenacapavir at lower costs for 120 low- and middle-income countries. However, the move faced criticism for excluding several nations, particularly in Latin America.

Efforts to overcome these barriers reflect a renewed push to prevent HIV in vulnerable populations without delay.