Gilead to extend access to lenacapavir and broaden its voluntary licences to include a new once-yearly formulation

What happened #1: An agreement between Gilead and the Pan American Health Organization (PAHO) establishes a pooled procurement mechanism through the Regional Revolving Funds to expand access to lenacapavir across 14 Latin American countries including nine low- and middle-income countries (LMICs)* – Brazil, Colombia, Ecuador, El Salvador, Guatemala, Mexico, Paraguay, Peru and Venezuela. 

Why it matters: The company is expanding access to lenacapavir in parts of the region with a rising burden of disease that were previously not included in the NEVLs and had no concrete access strategies. Brazil, Mexico, and Peru were also included in the pivotal clinical trials.

Looking ahead: The impact will depend on implementation. Gilead will need to ensure reliable and sufficient supply and work with PAHO to secure an affordable price, building on the PAHO Regional Revolving Funds’ established transparent processes. The company is also exploring local manufacturing opportunities with Brazil’s Ministry of Health, which could, in partnership with PAHO, support more sustainable, long-term regional access. 

What happened #2: Gilead has extended its existing NEVLs with the six generic manufacturers to include an investigational, once-yearly formulation of lenacapavir as pre-exposure prophylaxis (PrEP).  

Why it matters: This announcement comes at an early stage, ahead of the publication of Phase III results, as was also the case with Merck & Co.’s alimatravir. Early licensing agreements can enable generic manufacturers to prepare for production ahead of time and help accelerate access once the new formulation is approved. If successful in clinical development, a once-yearly formulation could help further address important barriers to HIV PrEP, including stigma and adherence.  

Looking ahead: Unlike the twice-yearly formulation, which is administered subcutaneously, the once-yearly formulation is administered intramuscularly at a higher dose and therefore requires marketing authorisations to be updated in line with regional regulatory procedures. Access will depend on Gilead’s regulatory strategy and the pace of technology transfer to support fast generic manufacturing and registration.

Progress made: A year ago, the Foundation highlighted gaps in regional access to lenacapavir. These announcements represent strong progress and underscore the need for continued efforts to make the twice- and once-yearly lenacapavir affordable and available to the people who need it the most. 

* The term LMICs covers all 113 countries in scope of the Access to Medicine Index