Gilead's Lenacapavir Distribution for HIV in Low-Income Countries

Gilead's Groundbreaking Agreement for Lenacapavir Distribution

Gilead Sciences has entered into noninclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers across Asia and North Africa to produce and commercialize lenacapavir in 120 nations with high HIV incidence. This initiative aims to facilitate access to lenacapavir, categorized as a pivotal agent for pre-exposure prophylaxis (PrEP) and HIV treatment for adults facing treatment-resistant HIV.

Key Countries Included in the Licensing Agreement

• Botswana
• Eswatini
• Ethiopia
• Kenya
• Lesotho
• Malawi
• Mozambique
• Nigeria
• Philippines
• Rwanda
• South Africa
• Tanzania
• Thailand
• Uganda
• Vietnam
• Zambia
• Zimbabwe

These agreements have become especially relevant following the results of a phase 3 clinical trial where 99.9% of 2,180 participants treated did not contract HIV. Approved by the FDA in December 2022, lenacapavir is administered as part of a combination therapy and entails an initial injection followed by semi-annual injections.

Criticism of the Licensing Strategy

While this partnership seeks to establish broad access to lenacapavir, numerous critics, including advocacy groups like the People's Medicines Alliance, argue that many middle- and high-income countries have been neglected. Countries such as Brazil, Colombia, Mexico, China, and Russia—representing roughly 20% of global HIV infections—are excluded from this initiative.

According to a statement from Daniel O'Day, chairman and CEO of Gilead, the agreements aim to facilitate widespread access to lenacapavir globally. However, concerns persist regarding the accessibility in economically diverse settings, where the burden of new HIV infections remains pronounced.