Gilead Expands HIV Drug Access, Yet Faces Criticism Over Exclusion of Middle-Income Countries

Gilead's Licensing Agreements:
Gilead Sciences has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to produce and distribute generic lenacapavir in 120 high-incidence, resource-limited countries, primarily low- and lower-middle-income countries.

Exclusion of Middle-Income Countries:
The agreement excludes many middle- and high-income nations, including Brazil, Colombia, Mexico, China, and Russia, which collectively represent around 20% of new HIV cases. This exclusion has been criticized for exacerbating healthcare access disparities.

Pricing and Access Issues:
Gilead sets the price for lenacapavir at $42,250 annually per patient in the United States. Critics argue that the exclusion of middle-income countries from the generic licensing agreement will make the drug unaffordable for many individuals in these regions.

Impact on Vulnerable Populations:
The exclusion of countries like Brazil, where clinical trials for lenacapavir were conducted, has been particularly criticized. Advocates point out that these countries have significant HIV burdens and that the exclusion will disproportionately affect marginalized communities such as migrants, sex workers, and people who inject drugs.

Gilead's Strategy: Gilead aims to support low-cost access to lenacapavir in high-incidence, resource-limited countries through a two-part strategy:
establishing a robust voluntary licensing program and planning to provide Gilead-supplied product at no profit until generic manufacturers can fully support demand.