Gilead Sciences' lenacapavir, a long-acting injectable drug administered every six months, has demonstrated remarkable efficacy in preventing HIV in recent clinical trials. The drug, already approved for treating multi-drug resistant HIV, showed 89% greater effectiveness than daily oral pre-exposure prophylaxis (PrEP) among gay, bisexual, and transgender individuals. However, the high cost of lenacapavir is raising concerns about equitable access and its potential impact on public health efforts.
Clinical Trial Results
An advanced clinical trial launched in 2021 across 88 sites in the U.S., Latin America, South Africa, and Thailand, involved over 3,250 cisgender men, transgender, and nonbinary people who have sex with male partners. Participants were randomized to receive either lenacapavir or Truvada in a double-blind, placebo-controlled study. Interim analysis revealed that only two out of 2,180 participants receiving lenacapavir contracted HIV, compared to nine out of 1,087 on Truvada. This represents an estimated 96% lower infection rate than would be expected without either drug.
Dr. Jared Baeten, senior vice president of virology clinical development at Gilead Sciences, described the results as "unprecedented," suggesting the drug's potential to "turn off new infections." The trial's blinded phase was ended early due to the clear statistical superiority of lenacapavir, and participants were given the option to receive either drug going forward. The drug was well-tolerated, with the only notable side effect being a visible deposit under the skin at the injection site in individuals with low body fat.
Cost and Accessibility
Despite the promising clinical results, the current list price of lenacapavir for HIV treatment is $3,450 per month. Gilead has not yet announced specific pricing for its use as PrEP, but a company spokesperson indicated that the PrEP pricing would differ from the treatment pricing. This has led to concerns among public health advocates about whether the drug will be affordable and accessible, especially given the availability of generic Truvada at around $20 per month.
Jen Kates, director of global health and HIV policy at KFF, emphasized the importance of ensuring access to this new tool for all who need it, both in the U.S. and globally. Advocates fear that the high cost could exacerbate existing racial disparities in HIV prevention, as Black and Latino gay and bisexual men have historically had lower PrEP adoption rates.
Potential Impact and Future Directions
Experts like Dr. Hansel Tookes from the University of Miami Miller School of Medicine are optimistic about lenacapavir's potential, particularly in regions like the Southern U.S., which accounts for half of all new HIV cases. The twice-yearly injection regimen may offer an easier and more appealing option compared to daily oral PrEP, potentially improving adherence and uptake.
Gilead plans to submit lenacapavir for FDA approval as PrEP by the end of the year, with potential market availability by mid-to-late 2025. Ongoing clinical trials are also evaluating the drug's efficacy in people who inject drugs and cisgender women in the U.S. The company has stated its commitment to delivering lenacapavir to high-incidence, resource-limited countries, but the details of these plans are still under discussion with the HIV community.
Tim Horn, director of medication access at NASTAD, stressed that the benefits of lenacapavir's clinical trials must extend to all people at risk for HIV, including those facing cost-related barriers to prevention and care.
