Aspen Pharmacare, South Africa's largest generic drug manufacturer, has stated that guaranteed demand is necessary for it to begin production of the long-acting HIV prevention injection, lenacapavir. The company's warning highlights a critical barrier to scaling up access to the breakthrough preventative in a region heavily burdened by HIV.
Lenacapavir, developed by Gilead Sciences, is a novel capsid inhibitor administered as a subcutaneous injection twice yearly. It has shown high efficacy in clinical trials for both HIV treatment and pre-exposure prophylaxis (PrEP). Regulatory approvals for its use as PrEP are pending with major health agencies, including the U.S. FDA and the European Medicines Agency.
South Africa has the world's largest HIV epidemic, with an estimated 7.8 million people living with the virus. Aspen, which has a licensing agreement with Gilead, has the capability to manufacture the drug at its sterile facility in Gqeberha. However, the company has emphasized that without firm purchase commitments from governments or global health organizations, it cannot justify the investment and production ramp-up required.
The call for guaranteed demand underscores a persistent challenge in global health: aligning manufacturing capacity with secure funding and procurement to ensure new health technologies reach populations in need, particularly in low- and middle-income countries.
