The Need for Lenacapavir Compulsory Licences in Ending the HIV Epidemic

Abstract In total, 1.3 million people acquired human immunodeficiency virus (HIV) in 2023, well behind the UNAIDS goal of <370 000 infections by 2025. Novel 6-monthly injectable pre-exposure prophylaxis (PrEP) medication lenacapavir is highly efficacious and could be epidemic-changing. However, without equitable access infection rates will continue. Gilead Sciences, the originator, currently charges over $40 000 per person-year for lenacapavir as HIV treatment, far exceeding PrEP cost-effectiveness thresholds, even in the richest countries. Yet the projected cost of production at scale is <$100 per person-year. Gilead's new voluntary license for lenacapavir prevention and treatment undermines access. Middle-income countries with fast-growing HIV epidemics have been excluded; 23% of new HIV infections occur in these countries. A coordinated response from governments, donors, civil society, and the private sector including Gilead is urgently required to ensure lenacapavir access is wide enough to eliminate HIV transmission worldwide. Unless crucial changes to the current license are made, compulsory licences may be required.