Sign in Subscribe
HIV

Global Fund Secures Access to Breakthrough HIV Prevention Drug Lenacapavir for Low- and Middle-Income Countries

Strategic Insights

— 2 min read

The Global Fund to Fight AIDS, Tuberculosis and Malaria has signed an access agreement with Gilead Sciences to procure lenacapavir, a long-acting injectable for HIV prevention, for low- and middle-income countries. This historic agreement marks the first time an HIV prevention product will be introduced in low- and middle-income countries at the same time as in high-income countries, a significant milestone for global health equity. The agreement follows the U.S. Food and Drug Administration's approval of lenacapavir for HIV prevention in June and represents one of the most significant advances in HIV prevention in decades.

Key Takeaways:

  • The Global Fund has signed an access agreement with Gilead Sciences to procure lenacapavir, a long-acting injectable for HIV prevention, for low- and middle-income countries.
  • This historic agreement marks the first time an HIV prevention product will be introduced in low- and middle-income countries at the same time as in high-income countries, a significant milestone for global health equity.
  • The agreement follows the U.S. Food and Drug Administration's approval of lenacapavir for HIV prevention in June and represents one of the most significant advances in HIV prevention in decades.
  • Lenacapavir is a twice-yearly, long-acting injectable for pre-exposure prophylaxis (PrEP) that expands the HIV prevention choice basket and offers a powerful new option for people who experience stigma, adherence challenges with existing PrEP tools, or other barriers in their daily lives.
  • The Global Fund aims to reach 2 million people with long-acting PrEP, but only if the world steps up with the resources required.
  • Countries supported by the Global Fund can access lenacapavir for PrEP, with early access prioritized based on HIV epidemiology, national prevention strategies, and available resources.
  • Partners including the World Health Organization (WHO), UNAIDS, the Gates Foundation, Unitaid, the Elton John AIDS Foundation (EJAF), AVAC, and CIFF are providing technical assistance, policy guidance, demand generation, and community mobilization to support implementation.
  • The Global Fund is leveraging private-sector donor funding to make the introduction and scale-up of lenacapavir more affordable for the countries and communities it supports.
  • The agreement is made possible through a unique coalition of partners providing vital assistance, policy guidance, demand generation, and community mobilization.

Statistics:

  • The Global Fund aims to reach 2 million people with long-acting PrEP.
  • Countries in sub-Saharan Africa, particularly those with high HIV incidence, have expressed strong interest in introducing lenacapavir for PrEP early and at scale.
  • The first shipment and delivery of lenacapavir products is expected to reach at least one African country by the end of 2025, marking the beginning of a transformational shift in how HIV prevention is delivered to communities with the highest burden of new infections.
  • The U.S. Food and Drug Administration approved lenacapavir for HIV prevention in June.
  • Lenacapavir is the first twice-yearly, long-acting injectable for PrEP.

Sources:

  • "Global Fund Secures Access to Breakthrough HIV Prevention Drug Lenacapavir" (The Global Fund, July 11, 2025)
  • Original text here: https://www.theglobalfund.org/en/news/2025/2025-07-09-global-fund-secures-access-breakthrough-hiv-prevention-drug-lenacapavir/ [Category: International]

Read more