The Gates Foundation has secured partnerships with Indian manufacturers to produce lenacapavir, the world’s first twice-yearly HIV prevention injection, at roughly $40 per patient annually, representing a dramatic cost reduction that could transform global epidemic control efforts.
The partnership with Hetero Labs, announced Tuesday in New York, leverages upfront funding and volume guarantees to enable generic manufacturing of the breakthrough treatment, which achieved 100% protection rates in clinical trials and requires only two injections per year.
Lenacapavir received U.S. Food and Drug Administration (FDA) approval in June 2025 as the first HIV prevention option offering six months of protection, marking a significant advancement over daily oral pre-exposure prophylaxis (PrEP) medications that face adherence challenges and stigma barriers.
The $40 annual cost represents a substantial reduction from branded pricing, addressing the primary barrier to widespread implementation across low- and middle-income countries (LMICs) where 1.3 million people acquired HIV in 2024, yet only 18% of people who could benefit from PrEP currently have access.
Dr. Vamsi Krishna, Managing Director of Hetero Group of Companies, emphasized the partnership’s strategic importance, stating the collaboration reflects commitment to ensuring access to innovative HIV medicines across India and other LMICs, potentially reaching millions previously excluded from prevention programs.
Parallel commitments announced simultaneously by Unitaid, the Clinton Health Access Initiative (CHAI), and Wits Research Health Institute (RHI) with Dr. Reddy’s Laboratories reinforce efforts to build competitive generic ecosystems, with accelerated development anticipated as early as 2027 pending regulatory approval.
The Gates Foundation has invested more than $80 million in catalytic funding to accelerate market readiness, scale delivery systems, and compress timeline for generic entry, demonstrating unprecedented commitment to ensuring scientific breakthroughs reach populations with greatest need and least ability to pay.
Trevor Mundel, President of Global Health at the Gates Foundation, positioned lenacapavir as potentially ending the HIV epidemic “if they are made accessible to people who can benefit from them the most,” emphasizing the foundation’s commitment to preventing highest-risk populations from being left behind.
The twice-yearly injection has been described as the most promising HIV prevention tool in decades, offering particular advantages for women who often face obstacles in negotiating condom use or maintaining daily medication adherence in settings where HIV stigma remains pervasive.
Modeling studies suggest that scaling affordable lenacapavir access to just 4% of populations in high-burden countries could prevent up to 20% of new infections, underscoring the potential epidemiological impact of cost reduction strategies implemented through these manufacturing partnerships.
The agreements complement existing collaborations between the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gilead Sciences, and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), supported by the Children’s Investment Fund Foundation (CIFF), to roll out initial supply in LMICs potentially reaching countries by end-2025.
Gilead Sciences granted royalty-free licenses in 2024 for lenacapavir production to six generic manufacturers covering 120 low- and middle-income countries, creating foundation for competitive pricing that the Gates Foundation partnerships are now leveraging to drive costs down further.
The Global Fund has credited its work with helping reduce HIV infection rates by 82% in supported countries since 2000, with the addition of low-cost lenacapavir expected to accelerate progress toward epidemic control, particularly in sub-Saharan Africa where HIV burden remains highest.
The Hetero agreement includes affordable supply of active pharmaceutical ingredient (API), enabling other generic manufacturers to scale production quickly and efficiently, creating supply chain resilience essential for sustained access across diverse healthcare systems and geographic regions.
Kate Hampton, Chief Executive Officer of the Children’s Investment Fund Foundation, described the generic deals as “a major step forward in ending the HIV epidemic,” building on full value-chain investments to foster competitive markets ensuring lenacapavir access remains affordable and reliable for all requiring treatment.
The announcement aligns with Gates Foundation’s broader $200 billion, 20-year commitment announced earlier this year, targeting three primary goals including ensuring the next generation grows up without suffering from deadly infectious diseases, with HIV epidemic control representing a cornerstone objective.
Earlier this week, Bill Gates announced the foundation’s $912 million pledge to the Global Fund’s 2026-2028 replenishment campaign, which aims to save 23 million lives from HIV, malaria, and tuberculosis between 2027 and 2029, with lenacapavir partnerships expected to increase impact through reduced costs at scale.
The strategic timing addresses urgent implementation needs, as countries with high HIV incidence, mostly in sub-Saharan Africa, require immediate access to effective prevention tools that can be delivered through existing national health systems and public procurement channels.
Success metrics will extend beyond cost reduction to include delivery system effectiveness, community acceptance, and integration with existing HIV prevention programs, requiring coordination across multiple stakeholders including governments, healthcare providers, and community-based organizations serving high-risk populations.
Source: newsghana.com.gh
