The HIV protection drug that only requires a single injection every six months has been approved by the United States Food and Drug Administration (FDA), but its high-cost sparks worry across the globe, including Uganda.
The injectable drug, lenacapavir, developed by Gilead Sciences is priced at $28,218 per year, approximately $107 million. This makes it one of the most expensive HIV prevention options ever introduced despite promising to be the most convenient, with just two doses required annually.
A recent Lancet HIV study revealed that generic versions of lenacapavir could be manufactured much more cheaply between $35 (Shs133,000) and $46 (Shs175,000) per person per year. With a larger rollout, the price could drop to $25 (Shs95,000) annually, making it comparable to or cheaper than current oral PrEP drugs.
Winnie Byanyima, Executive Director of UNAIDS and UN Undersecretary-General, welcomed the FDA approval but sharply criticized Gilead’s pricing.
“This is a breakthrough moment. The approval of lenacapavir is a testament to decades of public investment, scientific excellence, and the contributions of trial participants and communities,” she said.
She added, “I congratulate Gilead and US partners for advancing this important innovation. Lenacapavir could be the tool we need to bring new infections under control but only if it is priced affordably and made available to everyone who could benefit.”
Byanyima emphasized the need for equitable access: “UNAIDS has seen research that lenacapavir can be produced for just $40 (Shs 152,000) per year, falling to $25 (Shs95,000) within a year of rollout. It is beyond comprehension how Gilead can justify a price of Shs107 million. If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing and drop the price, expand production and ensure the world has a shot at ending AIDS.”
With over 1.4 million people living with HIV in Uganda, without a major pricing shift, access to lenacapavir will remain limited to the wealthy elites thus undermining efforts to end AIDS by 2030.
