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The Need for Lenacapavir Compulsory Licences in Ending the HIV Epidemic
Andrew Hill1, Mark J Siedner2, Cassandra Fairhead3
1Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, United Kingdom.
Insights
New injectable HIV prevention medication lenacapavir shows promise but high costs and limited access threaten its potential. Equitable global access is crucial to curb new human immunodeficiency virus infections and achieve epidemic control.
Area of Science:
- Public Health
- Infectious Diseases
- Pharmaceutical Policy
Background:
- 1.3 million new human immunodeficiency virus (HIV) infections in 2023 far exceed UNAIDS targets.
- Injectable pre-exposure prophylaxis (PrEP) like lenacapavir offers a potential breakthrough in HIV prevention.
- Current high pricing of lenacapavir by Gilead Sciences ($40,000+ per person-year) impedes access.
Purpose of the Study:
- To evaluate the accessibility and cost-effectiveness of lenacapavir for HIV prevention and treatment.
- To highlight the impact of Gilead's licensing strategy on global HIV epidemic control.
- To advocate for policy changes ensuring equitable access to lenacapavir.
Main Methods:
- Analysis of current HIV infection rates and UNAIDS targets.
- Assessment of lenacapavir's efficacy and projected production costs (<$100 per person-year).
- Review of Gilead Sciences' voluntary licensing agreement and its exclusions.
Main Results:
- Lenacapavir's production cost is significantly lower than its current treatment price.
- Gilead's licensing excludes middle-income countries, where 23% of new HIV infections occur.
- Existing access strategies are insufficient to achieve global HIV elimination goals.
Conclusions:
- Equitable access to lenacapavir is essential for controlling the HIV epidemic.
- Urgent coordinated action from governments, donors, civil society, and Gilead is needed.
- Compulsory licensing may be necessary if current access barriers are not addressed.
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.
