The US Food and Drug Administration (FDA) has approved lenacapavir for the prevention of HIV, marking a major milestone in the global fight against the virus. Clinical trial data from last year suggest that just two injections per year provide near-complete protection against HIV infection.
“This is a milestone moment in the history of HIV,” said Daniel O’Day, Chairman and CEO of Gilead Sciences, the pharmaceutical company that manufactures the drug. Lenacapavir had previously been approved for the treatment of HIV infection.
The newly approved injection offers a more convenient alternative to the current standard of care for HIV prevention, a daily oral pill known as Truvada. This form of pre-exposure prophylaxis (PrEP) has proven 99% effective at preventing HIV infection in clinical trials. However, for some individuals, daily adherence poses a significant challenge due to stigma, forgetfulness, or limited access to health services.
A biannual injection like lenacapavir could reach many more people, especially those who struggle with the burden of daily medication. Nevertheless, concerns over cost may limit accessibility. The list price for lenacapavir is reported at $28,218 (approximately Shs102 million) per person per year — a figure many consider prohibitively expensive.
In contrast, a research paper published this week in The Lancet HIV estimates that a generic version of lenacapavir could cost between $35 and $46 (Shs126,000–166,000) per person annually. The paper suggests that with a committed demand of five to ten million people within the first year, the cost could fall further to just $25 (around Shs90,000) per person annually — a price point that would make the drug more accessible than current oral PrEP options.
Reacting to the FDA’s approval of lenacapavir, Winnie Byanyima, Executive Director of UNAIDS and United Nations Under-Secretary-General, described the development as a game-changer:
“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. 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.
“UNAIDS has seen research indicating that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of roll-out. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing: drop the price, expand production, and ensure the world has a shot at ending AIDS.”
The FDA’s decision is grounded in data from two major clinical trials, PURPOSE 1 and PURPOSE 2, both published last year in peer-reviewed journals.
PURPOSE 1 followed more than 5,000 cisgender women in South Africa and Uganda starting in 2021. Remarkably, not a single woman who received lenacapavir contracted HIV during the trial. PURPOSE 2, which tracked over 3,200 participants — including cisgender men, transgender women and men, and gender non-binary individuals — found just two HIV infections among those who received lenacapavir, indicating an efficacy rate of 96%.
With these promising results, lenacapavir could play a transformative role in HIV prevention worldwide — but only if issues of affordability and equitable access are urgently addressed.
