Breakthrough HIV Prevention Shot Poised for Global Impact by 2025

In a significant stride toward combating HIV, a new long-acting injectable drug, lenacapavir, is on track to become accessible in low-income countries by late 2025 or early 2026. Hui Yang, head of supply operations at the Global Fund to Fight AIDS, Tuberculosis and Malaria, emphasized the urgency of this timeline, stating, "We don't want...low and low-middle income countries to wait, to be at the back of the line."

Lenacapavir, developed by Gilead Sciences, has already received approval in the United States for treating multi-drug resistant HIV, marketed under the brand name Sunlenca.

To ensure equitable access, the Global Fund is collaborating with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Children’s Investment Fund Foundation, and the Bill & Melinda Gates Foundation. This coalition aims to support affordable distribution of lenacapavir in resource-limited settings from the outset, targeting at least two million individuals over three years.

In October 2024, Gilead entered into royalty-free licensing agreements with six generic manufacturers to produce and distribute lenacapavir in 120 low- and middle-income countries.

The path to widespread availability involves securing regulatory approvals from authorities such as the U.S. Food and Drug Administration and the World Health Organization. While lenacapavir is currently approved for treatment purposes, its use as a preventive measure is still under review.

The advent of lenacapavir as a biannual injection represents a potential game-changer in HIV prevention, offering a more convenient alternative to daily oral medications. As global health organizations and pharmaceutical partners work to expedite access, the focus remains on overcoming logistical and regulatory challenges to deliver this promising intervention to those most in need.