Lenacapavir to Prevent HIV Infection: Updated Estimated Costs of Production for Generic Treatments

Abstract

Background: Lenacapavir/Sunlenca™ administered every 26 weeks as Pre-exposure Prophylaxis (PrEP) reduces HIV transmission to nearly zero. Affordable lenacapavir is a powerful and hitherto missing tool towards ending the HIV epidemic. Lenacapavir’s price is a critical determinant of access. The cost of production depends on the Cost-of-Goods (COGs) for the Active Pharmaceutical Ingredient (API) and conversion to finished pharmaceutical product (FPP). In 2024 we estimated generic lenacapavir could be produced for $41 and $94 per person-year depending upon volumes. Gilead Sciences has since signed licenses for generic lenacapavir for lower-income countries. Advances in manufacturing have reduced costs such that an updated analysis is urgently warranted.

Methods: Current lenacapavir Key Starting Materials (KSMs) prices were obtained from vendors. The commercial route of synthesis (ROS) was used to project API COGs from KSMs. The additional cost of formulation and Cost-plus projections were used to project FPP pricing at impactful volumes for mass treatment.

Findings: The cost of Key Starting Materials to prepare lenacapavir API has greatly decreased and a very efficient ROS has been published.  Based on this information an API COGs ranging from $6,340 - $8,921 /kg is achievable for a committed demand of two million treatment-years (4,000 kg/A of API). Adding formulation costs, with Cost-plus pricing, generic lenacapavir FPP is projected to cost $35-$46 per person-year. Modest improvements and growth in demand could lower this to $25 per person-year for a committed demand of five to ten million people.

Interpretation: We project that generic lenacapavir can be priced equal with or lower than current oral PrEP. With funding to support mass-production and global access, lenacapavir PrEP could be a highly cost-effective intervention to eliminate HIV.

Keywords: HIV, Pre-Exposure Prophylaxis (PrEP), HIV Prevention, lenacapavir, Sunleca, HIV Public Health, Ending HIV AIDS, HIV treatment access, Global Public Health (HIV), cost of HIV treatment, Access to Medicines, Active Pharmaceutical Ingredients (APIs), Finished Pharmaceutical Products (FPPs), generic medicines, voluntary licenses