Gilead Partners with Global Fund to Expand Access to Long-Acting HIV Prevention Drug

Gilead Sciences has announced a groundbreaking partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria, aimed at expanding access to its recently approved long-acting HIV pre-exposure prophylaxis (PrEP) drug, Yeztugo (lenacapavir). This collaboration marks a significant step in Gilead's comprehensive strategy to ensure global availability of the innovative HIV prevention medication.

Global Fund Partnership to Bridge Supply Gap

The agreement between Gilead and the Global Fund is designed to provide Yeztugo doses for up to 2 million people over a three-year period. Gilead has committed to supplying these doses at no profit, while the Global Fund will prioritize distribution to countries based on HIV epidemiology, national prevention strategies, and available resources.

Sepeter Sands, Executive Director of the Global Fund, emphasized the potential impact of this initiative, stating, "For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic—but only if we get it to the people who need it most."

This partnership serves as a stopgap measure to maintain an affordable supply of Yeztugo until Gilead's voluntary licensing program with generic manufacturers can meet global demand. The company had previously established agreements with six generic drug manufacturers to produce and distribute Yeztugo across 120 high-incidence, resource-limited countries.

Expanding Global Access Through Multiple Channels

Gilead's access strategy for Yeztugo extends beyond the Global Fund partnership. The company has submitted an application through the EU-Medicines for all (EU-M4all) regulatory track, which could expedite approval processes in other countries based on the European Medicines Agency's decision.

Additionally, Gilead is exploring various approaches to support access in regions not covered by the voluntary licensing program, including tiered pricing and potential public-private partnerships. However, the exclusion of some high-burden countries, particularly in Latin America, from the voluntary licensing program has drawn criticism from advocacy groups.

Guillermina Alaniz, director of global advocacy and policy at the AIDS Healthcare Foundation, voiced concerns about this disparity, stating, "We're seeing countries in Latin America systematically excluded from access to medical innovation—not because of science, but because of profit."

Unprecedented Approach to Global HIV Prevention

Gilead's CEO, Daniel O'Day, described the company's efforts as "an unprecedented approach to access for a medicine that could help end the HIV epidemic." The strategy combines voluntary licensing, partnerships with international organizations, and regulatory initiatives to maximize the reach of Yeztugo.

The drug received its first global approval from the U.S. Food and Drug Administration in June, marking a new era in HIV prevention. As Gilead continues to pursue regulatory approvals worldwide, the collaboration with the Global Fund represents a crucial step in realizing the potential of long-acting PrEP to combat the global HIV epidemic.