South Africa is asking local drugmakers to start a process to make Gilead Sciences’ long-acting HIV prevention drug, lenacapavir, domestically, in a push to bring production to the region where it is most needed.  

The government is working alongside international partners, including Unitaid and the United States Pharmacopoeia, to identify which local company could make the twice-yearly injection safely, effectively and affordably, and provide any support needed. They will then recommend that company to Gilead.

Gilead, a US pharmaceutical company, granted six voluntary licences in 2024 to generic manufacturers across India, Egypt and Pakistan to produce and supply the drug to 120 low- and middle-income countries. These included South Africa, although there was criticism that no South African drugmakers were included.

A licence for a South African company would be the seventh such deal, potentially boosting access to a drug many HIV/AIDS experts have said could help bring an end to the 44-year-old pandemic by slashing the numbers of new infections.

Gilead said it has been open to adding an additional voluntary license for local manufacturing in sub-Saharan Africa. "Gilead will review the proposals and assess whether required quality standards can be met before any voluntary license is granted," the company said in an email.

AFRICA REMAINS EPICENTRE OF HIV PANDEMIC
Despite progress, the African region remains the epicentre of the HIV pandemic. South Africa has the highest number of people affected at eight-million – around one in five adults – living with the virus. Several companies in South Africa already make HIV treatments or sterile injectables, like Aspen Pharmacare.

Paul Mashatile, chair of the South African National AIDS Council and deputy president, said making the drug in South Africa would benefit the whole region.

“Africa can no longer rely on medicines produced elsewhere for diseases that affect us most,” said Kenyan President William Ruto, African Union lead on local manufacturing of health commodities.

ACCESS CHALLENGES
In the past, low- and middle-income countries waited years for HIV drugs available in richer nations. Lenacapavir is already available in some African countries through an initiative supported by The Global Fund to Fight AIDS, Tuberculosis and Malaria and the US government, but demand is expected to outstrip supply until the generic manufacturers start making the drug.

Those agreements also faced some criticism for excluding middle-income countries like Brazil. A South African company could try to expand access there, too, Unitaid said.

“It’s an opportunity to open the door further,” said Unitaid’s director of program, Robert Matiru, although he said a licence for a South African company was the key aim.