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HIV

Global Fund and Gilead Sciences Sign Historic Access Agreement for HIV Prevention Medication

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 (LMICs). This marks the first time an HIV prevention product will be introduced in LMICs simultaneously with 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 a significant advance in HIV prevention. Lenacapavir is the first twice-yearly, long-acting injectable for pre-exposure prophylaxis (PrEP), offering a new option for people who experience stigma, adherence challenges, or other barriers in their daily lives.

"This is not just a scientific breakthrough -- it's a turning point for HIV/AIDS," said Peter Sands, Executive Director of the Global Fund. "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."

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 (LMICs).
  • This marks the first time an HIV prevention product will be introduced in LMICs simultaneously with high-income countries, a significant milestone for global health equity.
  • Lenacapavir is the first twice-yearly, long-acting injectable for pre-exposure prophylaxis (PrEP), offering a new option for people who experience stigma, adherence challenges, or other barriers in their daily lives.
  • 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.
  • The Global Fund aims to reach 2 million people with long-acting PrEP, but requires urgent and sustained investments to achieve this goal.
  • The agreement includes a commitment to focus on successful country implementation, ensuring delivery is community-led, culturally relevant, and sustainable.
  • Private-sector donor funding is being leveraged to make the introduction and scale-up of lenacapavir more affordable for the countries and communities it supports.
  • Partnerships with organizations such as the World Health Organization (WHO), UNAIDS, and the Gates Foundation are crucial in navigating introduction, accelerating regulatory pathways, generating demand, and ensuring community-led implementation.

Statistics:

  • The first shipment and delivery of lenacapavir are expected to reach at least one African country by the end of 2025.
  • The Global Fund aims to have lenacapavir available in at least 20 countries by 2026.
  • The agreement includes a commitment to reach 2 million people with long-acting PrEP.
  • HIV incidence in sub-Saharan Africa is disproportionately high, particularly among adolescent girls and young women.
  • The urgency is particularly acute in countries like South Africa, where adolescent girls and young women remain disproportionately affected by HIV.

Sources:

  • "The Global Fund to Fight AIDS, Tuberculosis and Malaria signs access agreement with Gilead Sciences for HIV prevention medication" (2025) Global Fund to Fight AIDS, Tuberculosis and Malaria.
  • "Peter Sands, Executive Director of the Global Fund" (2025) Global Fund to Fight AIDS, Tuberculosis and Malaria.
  • "Kate Hampton, CEO of the Children's Investment Fund Foundation (CIFF)" (2025) Children's Investment Fund Foundation (CIFF).
  • "Hui Yang, Head of Supply Operations at the Global Fund" (2025) Global Fund to Fight AIDS, Tuberculosis and Malaria.

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