Gilead Expands Access to Long-Acting HIV PrEP with Licensing Deals for Generic Lenacapavir

Licensing Agreement:
Gilead Sciences has entered into licensing agreements with six generic manufacturers to produce and distribute lenacapavir, a long-acting HIV prevention drug, in 120 low- and middle-income countries.

Early Licensing:
The agreements were announced before regulatory submissions for PrEP use, potentially reducing the time to market for generic products by up to three years.

Global Coverage:
The licenses cover regions with high HIV prevalence, including sub-Saharan Africa, but exclude many middle- and high-income countries such as Brazil, China, and Russia.

Pricing and Access:
The cost of lenacapavir for prevention is still unknown, and there are concerns about pricing transparency and equitable access.

Production and Availability:
Generic versions of lenacapavir are expected to be available by late 2027, with Gilead supplying the drug at a "no profit" price in covered countries until generics are operational and approved.

Market Impact:
The agreements are seen as a positive step towards accelerating access to long-acting HIV PrEP, but advocates emphasize the need for further efforts to ensure equitable and speedy access.