Gilead to Make Cheaper HIV Prevention Drug Available in 120 Countries

Gilead Sciences plans to make cheaper versions of lenacapavir, an HIV prevention drug, available in 120 low- and middle-income countries. Lenacapavir, administered as a twice-yearly injection, has demonstrated strong efficacy in preventing HIV infection.

The drug effectively halted infection in trials involving girls and women in South Africa and Uganda, and provided nearly complete protection in trials conducted across Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US.

Gilead has come under pressure to make lenacapavir accessible globally at a reduced cost. It currently sells for $42,250 a year in the US under the brand name Sunleca. Researchers estimate it could be produced for as little as $40 per year per patient.

Gilead has entered into agreements with six manufacturers to produce generic lenacapavir for 120 "high-incidence, resource-limited" countries. The company will also supply Gilead-produced product until the manufacturers are operational, prioritizing 18 high-HIV-rate countries such as Botswana, South Africa, and Thailand.

Critics argue that the deal excludes many high-HIV-burden countries, particularly in Latin America. Dr. Mohga Kamal-Yanni of the People’s Medicines Alliance asserts that the agreements have "draconian conditions" that could impede access in excluded countries.

Winnie Byanyima, UNAids executive director, calls for lenacapavir access for all who would benefit. She warns that excluding upper middle-income countries, where 41% of new infections occur, undermines the drug's potential impact.

UNAids is still awaiting specific pricing details and full transparency on Gilead’s costs. The generic manufacturers include India’s Dr Reddy’s Laboratories, Emcure Pharmaceuticals, and Hetero Labs, US-based Viatris’ unit Mylan, Egypt’s Eva Pharma, and Pakistan-based Ferozsons Laboratories.