* Generic lenacapavir could be produced for $25 per person per year at scale, according to an analysis presented at IDWeek 2025 in Atlanta.
New data presented at the 2025 IDWeek conference in Atlanta, Georgia, indicate that generic versions of lenacapavir, a twice-yearly injectable for HIV prevention, could be produced for as little as $25 per person per year—roughly 1,000 times less than its current US launch price of $28,218.1,2
The study, conducted by researchers from the University of Liverpool and Howard University, analyzed ingredient and manufacturing costs to update 2023 estimates on potential pricing for generic lenacapavir. Using key starting material data from vendors in seven countries, researchers modeled active pharmaceutical ingredient (API) and finished product cost-of-goods based on current routes of synthesis and cost-plus pricing.
At production volumes supporting 2 million treatment-years, the analysis estimated manufacturing costs between $35 and $46 per patient per year, dropping to $25 per patient per year if demand reached 5 million people.¹,² These projections include allowances for formulation, labor, a 30% profit margin, and 27% taxation.1
Researchers estimated global lenacapavir demand using transmission data from the PURPOSE-1 and PURPOSE-2 clinical trials, which showed the therapy reduced HIV acquisition to nearly zero. Approximately 1.3 million people acquired HIV in 2023, and UNAIDS predicts that 6 million more will acquire HIV because of international HIV/AIDS prevention funding cuts.
Researchers note that these funding changes will position affordability to play an even greater role in broader prevention efforts. An estimated 54 million to 55 million people per year could use lenacapavir to prevent or manage symptoms of HIV infection. More than 39,000 people were newly diagnosed with HIV in the United States in 2023, and an estimated 1.2 million people in the United States are currently living with HIV.
“Lenacapavir is the closest thing to a vaccine for HIV available to people at risk of infection, yet its unsustainable cost prevents millions from accessing it,” said Andrew Hill, PhD, senior visiting research fellow at Liverpool University and presenting author. “Our analysis demonstrates how manufacturers could prioritize both equitable access and profits in tandem and realize the full potential of lenacapavir to end the HIV epidemic.”
“Lenacapavir’s manufacturer, Gilead Sciences, has discovered and brought a revolutionary new drug to the market to limit the spread of HIV — but such innovations are useful only when they are available and affordable,” said Joseph Fortunak, PhD, professor of chemistry and pharmaceutical sciences at Howard University and lead researcher of the study. “While Gilead has taken an important step in licensing less-expensive, generic production of lenacapavir in India, Pakistan and Egypt, more funding and licensing can lower the cost to consumers to prevent new infection and treat those living with HIV.”
Lenacapavir is a first-in-class HIV capsid inhibitor that prevents viral replication and is the first long-acting injectable approved for both HIV treatment and prevention. It was approved by the FDA for treatment in December 2022 and for prevention in June 2025.2
References:
