Government seeks domestic manufacturer for Gilead’s long-acting HIV prevention injection to expand access across Africa.

South Africa is asking local drugmakers to begin the process of producing Lenacapavir domestically, in an effort to expand access to the HIV prevention treatment in the region where it is most needed.

The government says it is working with international partners including Unitaid and the United States Pharmacopeia to identify a local company capable of safely and affordably producing the twice-yearly injection. The selected manufacturer would then be recommended to Gilead Sciences.

Gilead granted six voluntary licences in 2024 to generic manufacturers in India, Egypt and Pakistan to produce and supply the drug to 120 low and middle-income countries, including South Africa. The move drew criticism because no South African companies were included.

If approved, a licence for a South African manufacturer would become the seventh such agreement and could help expand access to a drug many HIV experts say could significantly reduce new infections.

Gilead said it is open to adding a voluntary licence for manufacturing in sub-Saharan Africa but noted that proposals must meet strict quality standards before approval.

Despite treatment progress, Africa remains the centre of the HIV pandemic. South Africa has the world’s largest number of people living with the virus, with about eight million infected.

Deputy President Paul Mashatile said producing the drug locally would benefit the wider region.

William Ruto, the African Union lead on local manufacturing of health products, said Africa should no longer depend on medicines produced elsewhere for diseases that heavily affect the continent.

CBI News reports that Lenacapavir is already available in some African countries through programmes backed by the Global Fund to Fight AIDS, Tuberculosis and Malaria and the United States government.

However, demand is expected to exceed supply until generic manufacturers begin producing the drug.