South Africa Pushes for Local Manufacturing of Breakthrough HIV Prevention Drug

South African officials are working with international partners to identify domestic manufacturers capable of producing Gilead's revolutionary HIV prevention injection. The move aims to expand access to lenacapavir in the region most affected by the HIV pandemic, where South Africa has 8 million people living with the virus.

Officials in South Africa are taking steps to bring manufacturing of a groundbreaking HIV prevention medication to their own shores, working with global health organizations to identify capable local pharmaceutical companies.

The South African government has partnered with Unitaid and the United States Pharmacopoeia to find domestic manufacturers who can safely and affordably produce lenacapavir, Gilead Sciences’ twice-yearly injection that many experts believe could be a game-changer in ending the decades-long HIV pandemic.

Last year, the American pharmaceutical giant Gilead awarded six manufacturing licenses to generic drug producers in India, Egypt and Pakistan, allowing them to supply the medication to 120 developing nations, including South Africa. However, critics pointed out that no South African companies were selected for these agreements.

A seventh license for a South African manufacturer could dramatically improve access to the drug in a region where it’s desperately needed. The medication has the potential to significantly reduce new HIV infections and help end the pandemic that has persisted for 44 years.

Gilead has expressed willingness to consider additional manufacturing partnerships 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 stated in an email response.

The African continent continues to bear the heaviest burden of HIV infections worldwide. South Africa leads all nations with 8 million people living with HIV – approximately one in every five adults. The country already has pharmaceutical companies like Aspen Pharmacare that manufacture HIV treatments and sterile injectable medications.

Paul Mashatile, who chairs the South African National AIDS Council and serves as deputy president, emphasized that domestic production would benefit the entire African region.

Kenyan President William Ruto, who leads African Union efforts on local health commodity manufacturing, stressed the importance of regional self-reliance. “Africa can no longer rely on medicines produced elsewhere for diseases that affect us most,” Ruto said.

Historically, developing countries have waited years to access HIV medications that were readily available in wealthier nations. While lenacapavir is currently available in some African countries through programs supported by The Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. government, demand is expected to exceed supply until generic manufacturers begin production.

The existing licensing agreements have also faced criticism for excluding middle-income nations like Brazil. A South African manufacturer could potentially help expand access to these countries as well, according to Unitaid officials.

Robert Matiru, Unitaid’s program director, described the potential South African partnership as a chance to broaden access further, though he emphasized that securing a license for a South African company remains the primary objective.