Agreements to provide affordable lenacapavir

Agreements to provide affordable lenacapavirOn Sept 24, 2025, two agreements were announced between funders and generic drug manufacturers.The two agreements ensured the availability of groundbreaking twice-yearly injectable HIV pre-exposure prophylaxis (PrEP) drug lenacapavir at an annual price of US$40 per patient in 120 low-income and middle-income countries (LMICs) from 2027.In Oct 2, 2024, Gilead Sciences (CA, USA), the manufacturer of lenacapavir, declared that it had signed licensing agreements with six generic drug man- ufacturers, including Dr. Reddy's Labora- tories (Hyderabad, India) and Hetero Labs (Hyderabad, India), to manufacture and sell the affordable and generic versions of lenacapavir for 120 countries (mainly LMICs) with high HIV incidence and limited resources. The countries included Ethiopia, Botswana, Eswatini, Malawi, Mozambique, Namibia, Rwanda, Zambia, and Viet Nam.Unitaid (Geneva, Switzerland), the Clinton Health Access Initiative (CHAI; Boston, MA, USA), and Wits Reproductive Health & HIV Institute (Wits RHI; Johannesburg, South Africa) will provide Dr. Reddy's Laboratories with monetary, regulatory, and technical support to develop optimum-quality generic versions of lenacapavir at an affordable price ($40 per patient per year) for LMICs by 2027, following regulatory approval, according to an agreement.Besides, the Gates Foundation (Seattle, WA, USA) have made an agreement with Hetero Labs, enabling the company to produce similarly low-cost, generic versions of lenacapavir, to make the treatment affordable for the national health systems of LMICs.However, the list of 120 countries excluded upper middle-income countries with significant HIV burdens, eg Brazil, Peru, and Mexico in Latin America, where the PURPOSE 2 trial on lenacapavir's efficacy was conducted, as noted in an October 2025 Comment in the International Journal for Equity in Health.These exclusions spark