Generic Lenacapavir HIV Pre-Exposure Prophylaxis could be Produced for 25 Per Person Per Year

Abstract Background 1. 3 million people acquired HIV in 2023, far exceeding UNAIDS targets. Affordable prevention access is essential, particularly given recent aid cuts. Six-monthly lenacapavir pre-exposure prophylaxis reduces transmission to almost zero. Lenacapavir’s price is a critical determinant of access. Previously we estimated generic lenacapavir could be produced for 41 per person-year. Following recent licencing and manufacturing advances an updated analysis is urgently warranted. We therefore update these estimates at meaningful volumes, and project global lenacapavir demand. Methods June 2025 lenacapavir Key Starting Materials (KSMs) prices were obtained from vendors. Active Pharmaceutical Ingredient (API) Cost-of-Goods (COGs) from KSMs was projected using the commercial route of synthesis (ROS), assuming ≤2 API producers. Finished Pharmaceutical Product (FPP) Cost-plus steady-state model pricing for 2-5 million treatment-years was projected including formulation, labour, 30% profit and 27% taxation. Lenacapavir’s number-needed-to-treat in the PURPOSE-1/2 trials was multiplied by annual HIV acquisitions (1. 3 million) to project demand. Results Lenacapavir KSM costs (Figure 1) have greatly decreased (Table 1) and a novel efficient ROS (Figure 2) is available. An API COGs between 6, 340-8, 921/kg is achievable for a committed demand of two million treatment-years (4, 000 kg/year of API). With Cost-plus pricing, generic lenacapavir FPP is projected to cost 35-46 per treatment-year, reducing to 25 per treatment-year for five million people with expected modest manufacturing improvement (Table 2). Based on PURPOSE-1/2 number-needed-to-treats of 41. 5-42. 2, projected lenacapavir demand is 54-55 million people per year. UNAIDS predicts 6 million additional HIV acquisitions due to aid cuts: demand could therefore be several hundred million treatment-years by 2030. The 2 million lenacapavir treatment-years Gilead have committed to providing addresses 0. 5% of this potential need. Conclusion Generic lenacapavir could be priced lower than oral alternatives, and 1000 times less than Gilead’s launch price (28, 218). With funding and licencing to support global access, lenacapavir could be a highly cost-effective prevention intervention. Disclosures All Authors: No reported disclosures