Introduction to Lenacapavir
On September 24, 2025, a landmark agreement was reached to bring the groundbreaking HIV prevention tool, injectable lenacapavir, to 120 low- and middle-income countries (LMICs) at an astonishing cost of just $40 per year. This partnership between Dr. Reddy’s Laboratories, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI marks a pivotal moment in the fight against HIV, particularly in regions with high infection rates.
What is Lenacapavir?
Originally developed by Gilead Sciences, lenacapavir is a long-acting injectable HIV prevention medication, administered biannually. Its introduction comes at a crucial time; despite a global effort that has reduced new HIV infections by 40% since 2010, data from UNAIDS indicates that 1.3 million new infections were reported in 2024 alone. This innovative treatment could revolutionize the accessibility of HIV prevention, especially for individuals who find it difficult to adhere to daily oral pre-exposure prophylaxis (PrEP) regimens.
Making HIV Prevention Affordable
The new agreement not only makes lenacapavir affordable but also aligns its price with that of daily oral PrEP, which is pivotal for increasing uptake in LMICs. The rapid regulatory approvals from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have bolstered the initiative, leading to a WHO recommendation for lenacapavir in July 2025.
Strategic Support for Generic Production
With Unitaid’s backing, the partnership provides Dr. Reddy’s with essential technical, financial, and regulatory support to deliver quality-assured generic versions of lenacapavir by 2027. Typically, it takes over a decade to bring new medicines to LMICs; however, thanks to this strategic intervention, this timeline has significantly shortened.
Multi-Partner Strategy for Sustainable Access
This initiative is part of a broader strategy that includes multiple partners and suppliers, aimed at establishing a competitive and sustainable market for long-acting HIV prevention. Additionally, the Gates Foundation has secured a separate agreement with Hetero Labs to ensure a reliable supply of affordable options, contributing to long-term impact in communities worldwide.
Statements from Key Figures
Dr. Philippe Duneton, Executive Director of Unitaid, highlighted the importance of this agreement, emphasizing that the affordable price for lenacapavir proves that advanced medical tools can be accessible right from the beginning. Bill Clinton, President and Co-Founder of CHAI, stated that this breakthrough allows effective six-month protection against HIV at a comparable cost to daily pills, transforming the landscape of HIV prevention.
Commitment to Global Health
Dr. Reddy’s Laboratories’ commitment to enhancing patient access to innovative treatments is instrumental in this partnership. Deepak Sapra, CEO of API and Services at Dr. Reddy’s, reiterated their goal to impact 1.5 billion patients by 2030, reflecting a strong dedication to address the needs of underserved populations.
The Role of Generic Manufacturing
Generic production of lenacapavir ensures that this vital HIV prevention method is available to more people, rather than a privileged few. Professor Saiqa Mullick from Wits RHI stated that generics will drive prices down and secure sustainable supplies, making six-monthly PrEP a real option for millions in great need.
Future Directions
In October 2024, Gilead granted voluntary licenses to six generic manufacturers, including Dr. Reddy’s, for the distribution of lenacapavir across LMICs, paving the way for increased access. Furthermore, significant commitments from PEPFAR and the Global Fund, supported by the Children’s Investment Fund Foundation, aim to procure lenacapavir for up to two million individuals prior to generic availability, anticipated in 2027.
Conclusion
As stated by Kate Hampton, CEO of CIFF, making lenacapavir accessible and affordable is a critical step toward ending the HIV epidemic globally. This groundbreaking agreement showcases the power of collaboration and strategic planning in addressing urgent health challenges.
