Access to HIV pre-exposure prophylaxis (PrEP) 

Achieving rapid, broad and sustainable access to HIV PrEP in low- and middle-income countries (LMICs)

We’re initiating a multi-faceted access strategy for our investigational, once-monthly oral PrEP pill, alimatravir, while it’s in Phase 3 clinical development. Our goal is to provide rapid, broad and sustainable access to HIV PrEP in LMICs following potential regulatory approval. 

Globally, 1.2 million people acquired HIV in 2025, approximately 3,300 each day. According to the 2024 UNAIDS report, only 3.5 million people were using oral PrEP in 2023, demonstrating the urgent need to expand access and uptake to reach the global goal of 20 million people receiving PrEP by 2030.

“For more than four decades, our work in HIV has been guided by the people and communities we serve. Through ongoing dialogue with community leaders, advocates and global health stakeholders, we’re taking important first steps to support access in LMICs with the goal of shortening the time between potential approval of our once- monthly PrEP option and product availability.”

  • Chirfi Guindo
    Executive vice president, strategic access, policy & communications

Our commitment to HIV PrEP access: Rapid, broad and sustainable

Establishing early voluntary licensing agreements 

  • We’ve executed non-exclusive, royalty-free voluntary licensing agreements covering both private and public sectors with seven generic manufacturers — three in sub-Saharan Africa and four in India.
  • These agreements cover 129 countries, which account for the substantial majority of new HIV diagnoses globally. 
  • Executing these agreements before completion of Phase 3 enrollment is a first in HIV prevention. 
Close up of hand holding

Supporting targeted regional manufacturing

Sustainable access for HIV prevention requires reliable supply chains, strong local partnerships, country ownership and prioritization.

  • Africa: We’ve granted voluntary licenses to three manufacturers in sub-Saharan Africa: Aspen Pharmacare in South Africa, Quality Chemical Industries, Ltd. (Qcil) in Uganda and Universal Corporation Ltd. (UCL) in Kenya.

Investing early in manufacturing capabilities

  • We’re investing in manufacturing now to help ensure supply is available in LMICs covered by the seven voluntary license agreements soon after potential regulatory approval.  

HIV community engagement 

Engagement with HIV communities, advocates and global health stakeholders has shaped our access strategy. These perspectives informed our Phase 3 development program and our access planning to date, helping us identify the actions needed to accelerate availability, support scale-up and maximize public health impact.

Clinical trials

Our clinical development program for our investigational once-monthly oral PrEP candidate includes two large Phase 3 trials:

  • EXPrESSIVE-10:  among adolescent girls and young women in Kenya, South Africa and Uganda, in collaboration with the Gates Foundation and the International Clinical Research Center (ICRC) within the University of Washington Department of Global Health.
  • EXPrESSIVE-11:  among people with greater likelihood of HIV-1 acquisition in 16 countries globally, including sites in sub-Saharan Africa and seven countries in Latin America (Dominican Republic, Guatemala, Colombia, Brazil, Argentina, Chile and Peru), with support from the Gates Foundation.

Learn more about our HIV research.

More to come 

We recognize the work ahead and will continue to advance these access plans, guided by our partnership with the global HIV community.

This page was last updated in July 2026