Gilead in Talks to Register Twice-Yearly Lenacapavir HIV Jab in South Africa
Key Insights
Gilead Sciences is engaging with SAHPRA (search) to expedite the registration of its six-monthly anti-HIV (search) injection, lenacapavir, in South Africa.
Clinical trials have demonstrated lenacapavir's high efficacy in preventing HIV (search) infection in women and other high-risk groups.
SAHPRA (search) is exploring collaboration with the EU Medicines for All (EU-M4all) to accelerate the review process for lenacapavir.
Gilead Sciences is in discussions with the South African Health Products Regulatory Authority (SAHPRA (search)) to register its twice-yearly anti-HIV (search) injection, lenacapavir, aiming to expedite its availability in South Africa. This move follows promising trial results indicating the drug's potential to significantly reduce new HIV infections.
Lenacapavir's Efficacy and Global Access
Lenacapavir has shown remarkable efficacy in preventing HIV (search). Trial results published in July indicated 100% protection against HIV in women aged 16 to 25. Further studies presented at the 5th HIV Research for Prevention Conference in Peru demonstrated a 96% reduction in HIV infection risk among gay men, trans, and non-binary individuals aged 16 and older who have sex with male partners.
Gilead has committed to providing its branded lenacapavir injection to 18 countries, including South Africa, at a no-profit price until generic versions become available, expected around 2027. To facilitate broader access, Gilead has also issued licenses to six generic companies to produce and supply lenacapavir to 120 countries with high HIV (search) rates.
SAHPRA's Review Process and Collaboration
SAHPRA (search) faces challenges in reviewing new medicines due to understaffing, leading to potential delays. To address this, SAHPRA is exploring collaboration with the EU Medicines for All (EU-M4all) initiative to expedite the review process for lenacapavir. This collaboration would involve a joint evaluation with the European Medicines Agency (EMA), potentially reducing the review time to a maximum of seven months, followed by three months for local finalization.
Affordability and Procurement Strategies
The National Department of Health is proactively considering strategies to ensure affordable access to lenacapavir. This includes potentially publishing a request for information (RFI) to gather pricing and supply capacity data from manufacturers before SAHPRA (search)'s approval. The national essential medicines list committee (NEMLC) has initiated a review of lenacapavir's safety and efficacy data to determine a cost-effective price for South Africa.
The department is also evaluating the affordability of long-acting injectable PrEP options, comparing their costs to the current daily HIV (search) prevention pill, which costs the government R629.40 per year per patient. A cost model suggests that a lenacapavir jab should ideally cost no more than R624.36 per shot, translating to approximately R1,250 for a year of HIV protection.
Mitchell Warren, executive director of AVAC, emphasized the importance of creating demand to drive down prices through competition among generic manufacturers. He estimates that lenacapavir could be manufactured for as little as $40 per year per patient if taken up by 10 million people, allowing drug makers to still make a profit of 30%.