It’s possible to produce a generic version of lenacapavir, a twice-yearly antiretroviral injection that both prevents and treats HIV, for as little as $25 per patient per year, according to a study presented at the Infectious Disease Week (IDWeek) 2025 Annual Meeting in Atlanta.

Mass producing the drug at this price would substantially increase the number of HIV infections that could be prevented, even moving the world closer to ending the HIV epidemic, lead author Andrew Hill, PhD, senior visiting research fellow at the University of Liverpool, Liverpool, England, told attendees.

An estimated 1.3 million people acquired HIV globally in 2023, Hill noted, underscoring the importance of affordable access to prevention, especially with recent US federal cuts to HIV programs worldwide. However, the current cost of lenacapavir for preexposure prophylaxis (PrEP) in the US is approximately $28,218 per patient per year. The drug is currently manufactured and marketed by Gilead Sciences, Inc.

“Lenacapavir is the closest we’ve ever been to an HIV vaccine,” Hill told attendees. “We have a rare chance to end the HIV epidemic in the US, but only if lenacapavir is affordable.” His presentation focused primarily on the effects of lowering lenacapavir’s current price in the US, but he also addressed its potential impact in other countries where the current price is much higher.

Lenacapavir is a first-in-class long-acting drug that prevents viral replication of HIV by binding to the virus’ capsid proteins. In clinical trials, twice-yearly lenacapavir reduced the risk of contracting HIV by 100%. It outperformed current oral PrEP regimens, partly because of poor adherence with oral PrEP, Hill said. The FDA first approved lenacapavir for treating HIV in 2022, followed by approval for long-acting PrEP in June 2025.

A current US federal goal is to end the HIV epidemic in this country by the year 2030, which requires a 90% reduction in new HIV infections by 2030. Achieving that goal requires diagnosing HIV as early as possible, treating it quickly and effectively, protecting people at risk, and responding quickly to new clusters of cases, Hill said.

Currently, the US sees about 32,000-39,000 new HIV cases a year, but Hill said more widespread use of lenacapavir may provide an opportunity to reduce new cases by 30,000 per year. The biggest barrier, however, is cost.

Lenacapavir’s current price is 1128 times the cost of making the drug, and lowering the incidence by 30,000 people would require providing lenacapavir to 1.2 million people, based on the drug’s number needed to prevent transmission (41 people must be treated to avoid one acquisition) as identified in the PURPOSE 1 and 2 trials. The cost of that at current prices would be $34 billion a year, which is impossible to fund, Hill said.

His team therefore conducted a cost analysis as they have for other drugs, including sofosbuvir and daclatasvir for hepatitis C, linezolid for tuberculosis, and entecavir for hepatitis B. Their goal was to determine how much it costs to make 1 kg of lenacapavir and then how much it could be sold for, accounting for other manufacturing costs, while still making a profit.

The Cost of Producing 1 kg of Lenacapavir

A study last year by the same authors found that lenacapavir could be mass-produced for $41 per person per year, but they conducted this updated analysis because of new licensing and manufacturing advances that may affect their previous estimate.

The researchers procured price quotes per kilogram from Indian and Chinese vendors for the four key stage materials needed to synthesize the drug. They then estimated the cost to yield 1 kg of active pharmaceutical ingredient and added 5% for loss of active ingredients during formulation, 7% for overfill in vials, a 30% profit margin for generic suppliers, and a 27% tax on profits for drugs made in India.

To produce 4000 kg of active pharmaceutical ingredients to treat 2 million people, the cost would be $6340-8921 per kg, which translates to $13-18 per person. After adding $12-16 for formulation and vials and $9-13 for profit margin and taxes, it would cost $35-47 per person per year, or $69-94 million total.

If treatment were expanded to 5-10 million people, however, the cost drops to $5250 per kg, which translates to $25 per person per year, for a total cost of $250 million.

PEPFAR has already negotiated with Gilead to fund lenacapavir for $64 per person per year to treat approximately 1 million people annually starting in 2026, and the Gates Foundation, Clinton Foundation, and Unitaid have similarly arranged a price of $40 per person per year to begin treating 2 million people annually in 2027.

“Unfortunately, that level of supply is not large enough to have a significant effect on the HIV epidemic worldwide because after cuts in USAID [US Agency for International Development] funding, HIV incidence is predicted to go up from 1.3 million worldwide to 2.9 million worldwide, and this would only prevent 50,000 HIV infections worldwide,” based on the number needed to treat of 41, Hill said.

“We will need to be giving this drug to at least 10 million people worldwide to have a significant effect on the HIV epidemic, lowering incidence by half a million per year,” Hill said.

Cabotegravir as a Cautionary Tale

Hill pointed to cabotegravir, another PrEP drug that can prevent HIV when injected every 2 months, as revealing what happens when a drug is priced too high. The US price of cabotegravir is 884 times the cost price, he said, and after 3 years on the market, sales in Europe are close to zero because it has been determined not to be cost-effective. US sales, meanwhile, have been $260 million at the discounted price of $14,000 per person per year for 18,570 people — but that only prevents 435 cases of HIV, just 1.1% of US incidence in 2023.

Further, Gilead’s aforementioned licensing arrangements for $64 and $40 exclude countries where 30% of worldwide HIV transmission is occurring, including the US, Europe, and large parts of South America, Eastern Europe, and Asia.

“Many of those regions are where the epidemic is growing the most quickly,” and if nothing is done regarding lenacapavir’s high price, the drug “will only be used in rare situations, just like its predecessor cabotegravir,” Hill said in a separate media briefing.

“This excessive pricing policy is likely to block widespread access in the United States and Europe and many other countries” excluded from Gilead’s voluntary license, he said in the briefing, “so that HIV epidemics are likely to carry on growing. Meanwhile, Gilead is continuing to own over $20 billion per year, selling their HIV treatments for people already infected with HIV.”

Hill proposed that, instead, lenacapavir be sold at a cost of $25 per person per year in low- and middle-income countries and at $2000 per person per year in the US. “The drug is so cheap to make that it could be sold at any price and still make large profits,” he said. That price would enable 1.2 million more people to receive the drug as PrEP in the US and provide $2.4 billion in annual revenue to Gilead while reducing HIV incidence in the US by 30,000 people.

“People are speculating that this could help us to end AIDS by 2030,” he said. “This is the time for Gilead to do the right thing and lower lenacapavir prices to $2000 per year for PrEP.”

Reaction to Researchers’ Call to Action

Jeremiah Johnson, the executive director of PrEP4All, an organization that advocates for a national PrEP program in the US, told Medscape Medical News that he was not surprised that lenacapavir could be produced at such a low cost.

“We have been calling for a national PrEP program since our founding in 2018, which would emphasize access for un- and underinsured populations, and as part of that, we’ve leveraged the power of cheap, generic, daily oral medications,” Johnson said. “We have been saying for quite some time that we need a public health price for lenacapavir in particular for public programs, and what Dr Hill is presenting in here is exactly the kind of finding that makes sense in that conversation, that if you’re truly going to open the floodgates on PrEP, get it out at a level that’s going to have a meaningful impact on the epidemic, it’s going to have to be based on something that is still profitable for Gilead but not based on a price that is what the market will bear.”

A Gilead spokesperson told Medscape Medical News that Yeztugo, the company’s brand name for lenacapavir’s PrEP indication, “is a breakthrough in HIV prevention and is priced in line with existing branded PrEP options. We are committed to advancing HIV innovation, working with our partners, and supporting efforts to end the HIV epidemic in the US and globally,” the spokesperson said. “We are working to make Yeztugo accessible for those who need or want it.”

Johnson could not say whether $2000 per person per year would necessarily be a cost that policymakers would accept, but he pointed out a reason Gilead should at least consider discussing lower costs.

“The reality is, while Gilead absolutely championed this medication, the root of capsid inhibitors comes from taxpayer-funded innovation through NIH [National Institutes of Health],” Johnson said. “Dr Hill is making the case for Gilead to still make a profit. It’s nice to have it tied more toward the cost of production, at least, and then there’s probably some further conversation on what could actually move policymakers, but this is definitely a huge shift in the right direction.”

Information on funding was not provided. Hill reported having no disclosures. Johnson is executive director of the advocacy organization PrEP4All.

Tara Haelle is a science/health journalist based in Dallas.