Gilead Sciences has announced a collaboration with the US State Department and the President’s Emergency Plan for AIDS Relief (PEPFAR) to distribute its injectable HIV-1 capsid inhibitor, lenacapavir, as a preventative measure against HIV.
The collaboration aims to provide twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) for up to two million individuals by 2028 in regions supported by PEPFAR and the Global Fund.
The initiative is a crucial aspect of Gilead's broader strategy to improve access to lenacapavir for PrEP, particularly in low and lower-middle-income countries, pending approval.
To bolster this effort, Gilead has established royalty-free agreements with six generic makers to ensure supply for 120 resource-limited, high-incidence nations that bear a significant portion of the global HIV burden.
Gilead's strategy includes submitting regulatory filings for lenacapavir for PrEP in 18 nations, which collectively represent 70% of the HIV prevalence in the licensed territories, by the end of 2025.
It plans to supply the product at no profit until generic manufacturers can meet the demand in these regions.
For middle-income countries with a high HIV prevalence not included in the voluntary licensing programme, Gilead is implementing strategies to enhance access, such as tiered pricing and public-private collaborations.
In its pursuit of expedited global regulatory approvals, Gilead is leveraging recent positive developments, including a positive European Union-Medicines for all opinion and World Health Organization (WHO) prequalification processes, to streamline national regulatory evaluations and submissions.
The company is also utilising the WHO Stringent Regulatory Authority Collaborative Registration Procedure (WHO SRA CRP) to facilitate quicker access to the injectable for PrEP.
It is also exploring collaborations with organisations such as the Pan American Health Organization to extend access to countries beyond the scope of the voluntary licence.
In July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of lenacapavir for preventing HIV infection.
Gilead Sciences CEO and chairman Daniel O’Day stated: “The support of the US State Department through PEPFAR will accelerate access to lenacapavir and move us closer to ending the HIV epidemic.
“We are providing the medicine at no profit in this partnership so we can support the US government in delivering life-saving programmes where the need is most urgent.”
