NEW YORK, 2025-06-17
A Game-Changing HIV Drug: Accessible?
A new drug with the potential to end the HIV pandemic is set to launch in the U.S. this week, but its high potential cost raises concerns about accessibility.
- Lenacapavir, a twice-yearly injection, could prevent HIV infection.
- The drug’s potential cost is estimated at $25,000-$39,000 annually.
- Researchers say it could be produced for as little as $25 a year.
A new drug, lenacapavir, could potentially “end the HIV pandemic” and will launch in the U.S. this week. This innovative medication, administered as a twice-yearly injection, has shown promising results in clinical trials, but questions about its affordability loom large, making it an accessibility concern.
US regulatory approval is expected on June 19. Manufacturer Gilead is being urged to make the drug as affordable as possible. The company has not yet announced the official price. However, current estimates suggest it might be priced similarly to existing preventive medications, around $25,000 annually. As a treatment for those already living with HIV, it could cost about $39,000 per year.
The Price Conundrum
However, a study by the University of Liverpool and others suggests that lenacapavir could be produced for a mere $25 per year, including a 30% profit margin. Dr. Andrew Hill, one of the researchers, emphasized that making lenacapavir unaffordable in countries with significant HIV epidemics would be counterproductive. He also stated, “Even high-income countries will not be able to afford wide scale use of lenacapavir at prices above $20,000 a year.”
Dr. Hill had previously calculated a generic price of $40 annually. However, due to interest from generic manufacturers, a new analysis showed that lenacapavir could be mass-produced for $35 to $46 annually if there was an annual demand for 2 million doses. The cost could drop to $25 with scaled-up production of 5 million to 10 million doses each year.
Global Impact and Accessibility
In 2023, there were 1.3 million new HIV infections. The World Health Organization estimates that approximately 10 million people need to take HIV prevention drugs to achieve global goals.
Dr. Winnie Byanyima, UNAids executive director, said, “We have been urging Gilead to make lenacapavir available and affordable for all who need it. Dr. Hill’s research indicates that this gamechanging innovation could – within a year of launch – be produced and sold for just $25 per person per year. To charge 1,000 times more for a medicine with pandemic-ending potential would be abhorrent. We cannot end Aids with medicines that are so costly.”
Amid fears that aid cuts could reverse progress in controlling HIV, Byanyima noted that long-acting preventive medicines like lenacapavir could offer a breakthrough for countries and “turn off the tap of new infections”. She urged Gilead to “do the right thing, save countless lives, and end this pandemic”.
Gilead’s Commitments and Concerns
Gilead has established agreements with six generic companies to allow the production of low-cost versions of lenacapavir for 120 low-income countries. The company has also pledged to supply doses for approximately 2 million people at no profit before generic supplies become available.
European regulatory approvals are anticipated later this year, facilitating approval in many low- and middle-income countries. However, some campaigners point out that countries where a third of new HIV cases occur, including Brazil, Argentina, and parts of eastern Europe, are excluded by the Gilead scheme.
In a statement, Gilead said it “understands the importance of access for lenacapavir for PrEP [pre-exposure prophylaxis] if it is approved, and we’re taking steps at unprecedented speed to plan for access to lenacapavir for PrEP globally – particularly in low- and lower-middle-income countries where the need is greatest”. Gilead said global price planning was in progress and would take into account “nearly two decades of research and development, constant learning and iteration, and manufacturing investments to deliver lenacapavir at scale”.
