Millions of people in low- and middle-income countries (LMICs) are set to benefit from a groundbreaking HIV prevention drug that will soon be available at a fraction of its original cost.

On 24 September 2025 in New York, global health leaders announced that lenacapavir, a powerful injectable used for Pre-Exposure Prophylaxis (PrEP), will be made widely accessible through new pricing agreements.

Public health experts are hailing the development as a potential “game-changer” in the fight against HIV.

The Bill & Melinda Gates Foundation has partnered with Hetero Labs, an Indian pharmaceutical manufacturer, to produce a generic version of lenacapavir.

The generic will cost around $40 per patient annually—roughly KSh 5,000—making it affordable for national health systems in LMICs. To accelerate rollout, the Gates Foundation has committed over $80 million in upfront funding and volume guarantees.

Dr. Vamsi Krishna, Managing Director of Hetero Group, welcomed the deal:“Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir.”

Unlike traditional PrEP, which requires strict daily pill adherence, lenacapavir is administered just twice a year. A single injection provides six months of HIV protection, removing barriers such as stigma and adherence challenges.

The drug has already won regulatory approvals, with the U.S. FDA clearing it in June and the European Commission following in August.

The need for wider HIV prevention remains urgent. In 2024, an estimated 1.3 million people acquired HIV, yet only 18% of those eligible for PrEP currently have access to it.

Modelling suggests that making lenacapavir affordable and accessible to just 4% of people in high-burden countries could prevent up to 20% of new infections.

The first generic versions are expected by 2027, subject to regulatory approval. However, limited supplies may reach LMICs as early as late 2025 through programmes such as the Global Fund and PEPFAR.

Other partners, including Unitaid and Dr. Reddy’s Laboratories (DRL), are also pursuing parallel agreements to secure additional low-cost supply.

With its convenience, affordability, and strong protection, lenacapavir could reshape the global HIV prevention landscape—and bring the world closer to ending the epidemic.