Gilead’s Voluntary License on Lenacapavir: Key Limitations of the License and Recommendations to Improve Access

In 2023, 1.3 million people globally became newly infected with HIV, with one new infection every 24 seconds. There is an urgent need to scale up access to HIV medicines like lenacapavir, a long-acting antiretroviral (ARV) for HIV prevention and treatment.

Lenacapavir’s twice-yearly dosing offers distinct advantages in HIV prevention, such as improved adherence and less frequent visits to a health facility, making it critical for use in resource-limited settings, including those with MSF-supported programmes.  

However, when the pharmaceutical corporation Gilead Sciences (Gilead) announced it had signed non-exclusive bilateral voluntary licenses with six generic manufacturers for lenacapavir in October 2024, the restrictions of Gilead’s licensing agreement quickly became clear.  

This briefing document by MSF Access outlines the key features of Gilead’s voluntary license agreement for lenacapavir, highlights the limitations and challenges posed by the current terms of the license particularly in relation to broader access of lenacapavir, and recommends actions Gilead must take to expand access to lenacapavir.