South Africa Pushes for Local Production of Gilead’s HIV Prevention Drug

The government is seeking to establish local manufacturing of a long‑acting HIV prevention drug developed by it, as part of efforts to improve access to innovative treatments across the region.

Officials are encouraging domestic pharmaceutical companies to begin the process of producing lenacapavir, a twice‑yearly injectable drug designed to prevent HIV infection. The initiative aims to bring production closer to regions most affected by the virus while strengthening Africa’s pharmaceutical manufacturing capabilities.

Partnerships to Identify a Local Manufacturer

The South African government is working with global health organizations, including the WHO, to identify a local company capable of producing the drug safely and affordably. Once a suitable manufacturer is selected, the proposal will be submitted to Gilead for approval.

If approved, the arrangement could lead to a new voluntary manufacturing license for a South African company, potentially becoming the seventh such license granted for the drug. :contentReference[oaicite:6]{index=6}

Expanding Access to a Promising HIV Prevention Tool:

In 2024, Gilead granted voluntary licenses to six generic manufacturers located in India, Egypt, and Pakistan to produce and distribute lenacapavir in more than 120 low- and middle-income countries. However, the absence of South African manufacturers in those agreements drew criticism from public health advocates and regional leaders.

Adding a South African producer could increase supply and help expand access across the African continent, where HIV remains a major public health challenge.

A region at the center of the HIV epidemic,

Africa continues to bear a significant share of the global HIV burden, with it alone home to around eight million people living with the virus—the largest number in the world. :contentReference[oaicite:9]{index=9}

Health leaders argue that increasing local production capacity is essential to ensure faster and more equitable access to critical medicines for the region.

If a licensing agreement is reached, the move could strengthen regional supply chains and support broader efforts to reduce new HIV infections in the years ahead.