LIMA, PERU– The success of a long-lasting injectable HIV prevention drug, lenacapavir, which has shown remarkable effectiveness in human trials, will largely depend on its affordability and widespread distribution, according to global health experts.
Lenacapavir, developed by US pharmaceutical company Gilead Sciences, is a long-acting pre-exposure prophylaxis (PrEP) drug. It prevents HIV from entering the body and replicating. Unlike daily oral PrEP treatments, lenacapavir is administered every six months, making it the longest-acting injectable prevention method to date.
Gilead is currently seeking regulatory approval for lenacapavir in several African countries, where almost one in 25 people live with HIV. According to experts, making the drug accessible to people in low- and middle-income countries will be crucial to reducing new infections.
In a late-stage trial, the drug demonstrated impressive results, reducing HIV infection by 96 percent among diverse groups, including men who have sex with men, transgender individuals, and non-binary people. Only two out of more than 2,000 participants in the PURPOSE 2 study contracted HIV.
Mitchell Warren, executive director of the non-profit AVAC, emphasized the drug’s potential but stressed the need for mass production and equitable access. “We’re calling for an aggressive effort to make lenacapavir available to at least one million people in low- and middle-income countries within the first year of its rollout,” Warren said.
The real-world impact of lenacapavir will depend largely on its pricing. “If it’s affordable, lenacapavir could significantly reduce new infections here,” said Hasina Subedar, senior technical advisor at South Africa’s Department of Health.
One key advantage of lenacapavir is its twice-yearly administration, which could help overcome the adherence challenges that have affected oral PrEP. Colleen Kelley, an associate professor of Medicine at Emory University, noted that lenacapavir is “a highly effective tool for HIV prevention that is not dependent on daily oral adherence.”
However, experts warn that widespread availability will depend on the drug’s pricing and production. Gilead has entered into voluntary licensing agreements with several generic manufacturers to produce low-cost versions of lenacapavir, but the final pricing structure remains unclear.
To ensure widespread adoption, early models suggest that a year’s supply of lenacapavir would need to cost around US$40, comparable to the price of oral PrEP. Countries like Kenya and Zambia, which have experience with HIV prevention programs, are expected to be early adopters of the drug.
“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said Daniel O’Day, CEO of Gilead. The company is working with regulatory bodies to expedite approvals and pre-qualifications for the drug, especially in Africa.
Once approved, ensuring a reliable supply chain will be critical to building trust within communities. “The potential is exciting, but we still have many questions,” Warren added, noting concerns about whether patients will return for their injections every six months.
As Gilead moves forward with the regulatory process, the global health community is eager to see whether lenacapavir can help reduce HIV infections on a large scale, particularly in regions with the highest HIV burden.
