Geneva — In a landmark development in HIV prevention, the U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ long-acting injectable, lenacapavir, which offers a revolutionary six-monthly dose for people at risk of HIV.
This innovative treatment could transform prevention strategies worldwide, providing a convenient and highly effective option for millions.
Despite the excitement surrounding this breakthrough, concerns are mounting over the drug’s steep price. Gilead announced a U.S. retail price of $28,218 per person per year—raising questions about affordability and access, especially for low- and middle-income countries where HIV prevalence is highest.
Recent research published in The Lancet HIV suggests that generic versions of lenacapavir could be produced at a fraction of the cost estimated between $35 and $46 per person-year, and potentially as low as $25 with high-volume demand of five to ten million users annually.
Such pricing would make the drug comparable to or cheaper than existing oral PrEP options.
Reacting to the high price, Winnie Byanyima, Executive Director of UNAIDS and UN Undersecretary-General, issued a pointed statement noting that that the public had invested decades of research and resources into developing the medicine, yet Gilead’s price remained astronomically high.
“This approval marks a game-changing moment in HIV prevention. The scientific achievement is clear, but the real test now is affordability. The public has invested decades of research and resources into developing this medicine, yet Gilead’s price remains astronomically high. Our research shows it can be produced for just $40 per person per year, dropping to $25 after rollout. It’s incomprehensible how Gilead justifies such a vast gap. If this medicine remains out of reach financially, it will fail to make the impact it promises. I urge Gilead to do the right thing—reduce the price, expand production, and ensure equitable access so we can end AIDS,” she stated.
As the world accelerates efforts to reach the 2030 goal of ending the AIDS epidemic, the critical issue remains: making groundbreaking prevention tools like this six-month injection accessible and affordable for all.
UNAIDS emphasizes that true progress depends on global cooperation, public investment, and pharmaceutical responsibility.