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South Africa Pushes to Make Gilead’s ‘Game-Changer’ HIV Prevention Drug Locally

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South Africa is taking steps to produce one of the most promising HIV prevention drugs ever developedright on its own soil.

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

The Drug

Lenacapavir is a twice-yearly injection for HIV preventiona potential game-changer in the fight against a virus that has claimed millions of lives over four decades.

HIV/AIDS experts have said the drug could help bring an end to the 44-year-old pandemic by dramatically reducing new infections.

The Licences

In 2024, Gilead granted six voluntary licences to generic manufacturers in India, Egypt, and Pakistan to produce and supply the drug to 120 low- and middle-income countries.

South Africa was included as a recipient countrybut no South African drugmakers were included as manufacturers, a point of criticism.

A licence for a South African company would be the seventh such deal.

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.

The Need

The African region remains the epicentre of the HIV pandemic.

  • South Africa has the highest number of people affected8 millionaround one in five adults

  • Several South African companies already make HIV treatments or sterile injectables, including Aspen Pharmacare

The Political Push

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.

Kenyan President William Ruto, African Union lead on local manufacturing of health commodities, was blunt:

“Africa can no longer rely on medicines produced elsewhere for diseases that affect us most.”

The Access Challenge

Lenacapavir is already available in some African countries through an initiative supported by The Global Fund and the U.S. government. But demand is expected to outstrip supply until generic manufacturers start producing the drug.

Previous licensing agreements also faced criticism for excluding middle-income countries like Brazil. A South African company could try to expand access there too, said Robert Matiru, director of programmes at Unitaid.

“It’s an opportunity to open the door further,” Matiru saidthough he stressed that a licence for a South African company was the key aim.

The Bottom Line

South Africa wants to make its own HIV prevention drugs. The government is working with international partners to identify a local manufacturer. Gilead is willing to consider a seventh licence.

For the 8 million South Africans living with HIVand the millions more across Africathis could be a turning point.

The question is not whether the drug works. It’s whether it will be made here, for here, by here.

 

{Source: Reuters}

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