On September 24, 2025, a significant partnership was announced between the Gates Foundation and Indian manufacturer Hetero Labs, aimed at broadening access to a generic version of lenacapavir. This partnership will provide millions of people in low- and middle-income countries (LMICs) with a low-cost, effective prevention option against HIV through a twice-yearly injectable pre-exposure prophylaxis (PrEP).
The collaboration between the Gates Foundation and Hetero Labs is backed by essential upfront funding and volume guarantees. This support will enable Hetero to produce generic lenacapavir at an estimated cost of just $40 per patient per year, following a short pre-treatment oral regimen. This pricing strategy is designed to make this groundbreaking treatment accessible and affordable for national health systems, significantly impacting HIV prevention efforts.
Dr. Vamsi Krishna, managing director of Hetero Group of Companies, expressed enthusiasm about the partnership, stating, “Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir.” He emphasized the collaboration’s commitment to ensuring access to innovative HIV medicines for patients across India and other LMICs.
In tandem with this announcement, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI revealed new commitments with Dr. Reddy’s Laboratories Ltd. (DRL), another Indian manufacturer. This initiative aims to further strengthen the generics ecosystem for lenacapavir. The anticipated large-scale generic supply of lenacapavir could be available as early as 2027, pending regulatory approvals, thereby reducing the time between initial doses and increasing access to this critical drug.
This strategic move holds the potential to revolutionize the fight against HIV, facilitating quicker and more equitable access to treatment, which can hasten efforts to end the epidemic.
The new partnerships complement existing agreements between the Global Fund to Fight AIDS, Tuberculosis and Malaria; Gilead Sciences; and the U.S. State Department through PEPFAR. These collaborations are geared towards rolling out the initial supply of lenacapavir in LMICs, with potential reach to countries by the end of 2025.
Lenacapavir has been approved by the U.S. FDA in June and the European Commission in August, offering six months of protection with a single injection. Public health experts view this as a transformative option for individuals facing barriers to daily oral PrEP, such as stigma, adherence challenges, and inconsistent access to medications.
Despite the progress made globally in reducing HIV rates and AIDS-related deaths since 2000, 1.3 million people acquired HIV in 2024. Alarmingly, only 18% of those who could benefit from PrEP currently have access. Studies indicate that scaling up access to affordable lenacapavir could prevent a significant number of new HIV infections. For instance, one study suggests that introducing lenacapavir to just 4% of the population in high-burden countries could prevent up to 20% of new infections.
The Gates Foundation has made over $80 million in catalytic investments aimed at accelerating market readiness and scaling delivery for lenacapavir. Trevor Mundel, president of global health at the Gates Foundation, stated, “Scientific advances like lenacapavir can help us end the HIV epidemic—if they are made accessible to people who can benefit from them the most.”
The foundation’s commitment reflects ongoing collaborations with governments, communities, and partners like the Global Fund and PEPFAR to ensure that regulatory approvals and delivery systems are in place, expediting the delivery of scientific breakthroughs to populations in need.
Earlier this week, Bill Gates announced the foundation’s $912 million pledge to the Global Fund’s 2026-2028 replenishment fundraising campaign, which aims to save 23 million lives from HIV, malaria, and tuberculosis between 2027 and 2029. The recent agreements with Hetero and DRL are expected to enhance the Global Fund's impact by reducing costs at scale, ultimately benefiting those at highest risk of HIV.
In 2024, Gilead Sciences granted royalty-free licenses for lenacapavir production to six generic manufacturers for 120 LMICs. Once regulatory approvals are in place, generic lenacapavir will be distributed through national HIV programs and public procurement channels, including the Global Fund. The agreement with Hetero also ensures an affordable supply of the active pharmaceutical ingredient (API), allowing other generic manufacturers to scale production quickly and efficiently.
Kate Hampton, CEO of the Children’s Investment Fund Foundation, remarked, “The deals announced today on generics are a major step forward in ending the HIV epidemic.” This initiative builds on comprehensive investments by CIFF and others to foster a competitive market, ensuring that access to lenacapavir remains affordable and reliable for everyone in need.
