Lenacapavir: a groundbreaking HIV prevention tool set to cost just $40 per year

In a groundbreaking development for global health, injectable lenacapavir, a revolutionary HIV prevention tool, will be accessible at an unprecedented cost of US$40 (R698) per year to 120 low- and middle-income countries starting in 2027. This significant announcement comes from a coalition partnership involving Dr. Reddy’s Laboratories, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI, marking a pivotal moment in the fight against HIV/AIDS.

Originally developed by Gilead Sciences, lenacapavir is a long-acting injectable that requires administration only twice a year, demonstrating remarkable efficacy in preventing the transmission of HIV. While efforts since 2010 have managed to reduce new HIV infections by 40%, the UNAIDS reported that1.3 million new infections occurred in 2023, underlining the urgent need for effective prevention methods. Lenacapavir's introduction provides a crucial alternative for those who face challenges adhering to daily oral pre-exposure prophylaxis (PrEP) regimens, making it a vital tool in the ongoing battle against the epidemic.

The deal, brokered through collaborative efforts by CHAI and Unitaid equips Dr. Reddy’s Laboratories with comprehensive financial, technical, and regulatory support aimed at delivering affordable and quality-assured generic forms of lenacapavir by 2027. This launch will occur less than two years following the regulatory approval of Gilead’s branded product in high-income countries, a significant advancement compared to the usual decade-long process for making new medicines accessible in lower-income regions.

Dr. Philippe Duneton, Executive Director of Unitaid, highlighted the importance of this agreement by 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.” This agreement not only levels the cost of lenacapavir to that of oral PrEP but also exemplifies Unitaid's dedication to ensuring significant health innovations reach those who need them most.

Further acknowledging the monumental impact of this partnership, President Bill Clinton, Board Chair and Co-Founder of CHAI, commented, “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.” He expressed pride in CHAI’s role in combating the epidemic and providing a genuine opportunity to bring an end to it.

Deepak Sapra, CEO of API and Services at Dr. Reddy’s Laboratories, affirmed that “this partnership combines our deep science and market expertise with our partners’ technical, financial, and regulatory strengths,” underscoring a shared commitment to addressing the health needs of underserved populations globally.

As the clock ticks closer to the generics' market entry, October 2024 will witness Gilead granting voluntary licenses to six generic manufacturers, including Dr. Reddy’s, to produce lenacapavir across the aforementioned low- and middle-income nations. To ensure immediate access, a collaborative commitment involving PEPFAR, the Global Fund, and the Children’s Investment Fund Foundation (CIFF) is set to procure lenacapavir for prevention for up to 2 million individuals in these regions.

Kate Hampton, CEO of CIFF, referred to this initiative as a significant advancement on a sustainable path toward eradicating the HIV epidemic, reinforcing the notion that a competitive market is essential for making lenacapavir accessible and reliable for all who require it.

The collaborative efforts also extend beyond just manufacturing and pricing. Unitaid's strategy includes integrating lenacapavir into existing HIV prevention frameworks while engaging communities and health systems in early adopter countries to facilitate effective adaptation. This comprehensive approach incorporates real-world research to address crucial implementation issues and explores new methods for decentralized, community-based delivery systems across sub-Saharan Africa.

As the global health landscape shifts towards a more inclusive model for HIV prevention, Unitaid remains dedicated to addressing access challenges in countries outside the current agreements, with the aim of making long-acting prevention methods accessible to all at risk.