Gilead Licenses HIV-Prevention Drug to Generic Manufacturers for Wider Access

US pharmaceutical giant Gilead announced on Wednesday that it has signed licensing deals with six generic drugmakers to produce and sell its HIV-prevention drug, lenacapavir, in 120 lower-income countries. This move aims to increase global access to the antiretroviral drug, which has shown 100% effectiveness in early trials for preventing HIV infections.

The decision follows pressure on Gilead to open lenacapavir to a patent pool, allowing generics to be sold under license in countries with high HIV prevalence. This would enable low-cost production of the drug, which currently costs over $40,000 per person per year in some countries, although it is estimated that generics could be produced for as little as $40 per year.

Gilead’s CEO Daniel O’Day stated that the company is working urgently with high-volume generic manufacturers to begin production after securing regulatory approvals. Lenacapavir, which only needs to be injected twice a year, offers a simpler alternative to daily HIV prevention pills, making it easier for people to adhere to the treatment.

International health agency Unitaid welcomed the licensing deals, emphasizing the need for swift global access to the drug. Unitaid’s executive director, Philippe Duneton, described lenacapavir as a “game-changing medication” that could significantly reduce new HIV infections.

As of last year, 1.3 million new HIV infections were reported, with 39 million people currently living with the virus worldwide. Gilead plans to prioritize the registration of lenacapavir in 18 high-incidence countries, including Ethiopia, Kenya, South Africa, Thailand, and Vietnam, until generic versions become available.