Introduction to Lenacapavir
In a groundbreaking development for global health, a new injectable HIV prevention tool, lenacapavir, is set to be available at an astonishingly low price of just US$40 per year in 120 low- and middle-income countries (LMICs). This significant milestone comes as part of a landmark agreement announced on September 24, 2025, involving Dr. Reddy’s Laboratories, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI.
The Promise of Lenacapavir
Lenacapavir, originally developed by Gilead Sciences, is a long-acting injectable form of pre-exposure prophylaxis (PrEP) that only requires administration twice a year. This innovative product has shown remarkable efficacy in preventing HIV infections, providing hope for millions who struggle with the adherence required by daily oral PrEP pills. The agreement to bring lenacapavir to LMICs is crucial, especially as UNAIDS reported 1.3 million new HIV infections in 2024, underlining the urgent need for innovative solutions.
A Transformational Collaboration
The rapid regulatory approvals from the U.S. Food and Drug Administration and the European Medicines Agency demonstrate the global commitment to combatting HIV. Furthermore, the World Health Organization (WHO) issued a global recommendation for lenacapavir in July 2025, paving the way for its widespread adoption.
This partnership, facilitated by CHAI and Unitaid, empowers Dr. Reddy’s with financial, technical, and regulatory support to ensure the availability of affordable, quality-assured generic versions of lenacapavir by 2027. This timeline is remarkable, representing less than two years post-approval in high-income countries, a significant reduction from the typical decade-long wait for new medicines in LMICs.
A Sustainable Market Approach
The agreement is part of a larger strategy to create a competitive and sustainable market for long-acting HIV prevention options. A crucial element of this effort is an additional agreement secured by the Gates Foundation with Hetero Labs, ensuring multiple affordable options and a reliable supply chain. This multi-supplier strategy is vital for long-term impact and accessibility.
Comments from Key Stakeholders
Unitaid’s Executive Director, Dr. Philippe Duneton, emphasized the historic nature of this agreement, stating, “Securing a US$40 price for the twice-yearly lenacapavir injection for PrEP is a historic breakthrough that proves the most advanced tools can be made affordable from the very start.”
Former President Bill Clinton, Board Chair of CHAI, highlighted the transformative potential of this partnership. “The ability to protect someone for six months with a single injection, at the same cost as the currently available daily pills, is truly transformational. This partnership marks a remarkable breakthrough in HIV prevention.”
Impact on Global Health
Deepak Sapra, CEO of API and Services at Dr. Reddy’s Laboratories, affirmed the partnership’s significance, noting, “The development and planned supply of a high-quality, affordable generic version of lenacapavir represents a crucial advancement in the prevention of HIV. This reinforces our commitment to addressing the needs of underserved populations globally.”
In October 2024, Gilead granted voluntary licenses to six generic manufacturers, including Dr. Reddy’s, to produce lenacapavir, underscoring the collective efforts to enhance access. Simultaneously, commitments from PEPFAR and the Global Fund further support the procurement of lenacapavir for up to 2 million individuals in LMICs, ensuring that this vital resource reaches those in greatest need.
Conclusion
The recent agreements regarding lenacapavir mark a pivotal moment in the fight against HIV. By making this innovative prevention tool affordable and accessible, we move one step closer to combating the epidemic and ensuring that everyone, regardless of their economic status, has the opportunity to protect themselves from HIV.
