Earlier this month, Unitaid announced its collaboration with the South African government to engage Gilead Sciences in discussions about lenacapavir, a next-generation HIV preventive medicine. The talks aim to secure a voluntary license that would allow local generic manufacturers to produce the drug, increasing regional access and strengthening local pharmaceutical capacity.
Unitaid, a global health initiative under the World Health Organization, is working alongside the South African National AIDS Council (SANAC) and the independent scientific body US Pharmacopeia (USP) to identify capable South African manufacturers. An expression of interest has been published to find facilities able to produce both the active pharmaceutical ingredients and the finished product, ensuring quality standards are met before any license is granted.
Gilead has expressed support for an additional voluntary license in Sub-Saharan Africa, following the success of its PURPOSE 1 trial for pre-exposure prophylaxis (PrEP), which showed 100% protection against HIV infection in adolescent girls and women when administered twice yearly. Six voluntary licenses have already been granted in key endemic regions, with South Africa prioritized due to its high HIV incidence.
SANAC emphasized that producing lenacapavir locally will not only benefit South Africans but also strengthen regional resilience, expand equitable access, and advance collective efforts to end HIV. Unitaid and USP will provide technical and financial support through the Medicines Supply Resilience (MedSuRe) Africa program, offering over $35 million to facilitate local production and distribution.
Unitaid Director Robert Matiru highlighted that expanding access to lenacapavir is essential for creating a sustainable market, enabling large-scale production, lowering prices, and preventing new HIV infections while fostering a competitive pharmaceutical landscape in the region.
