Median (IQR) plasma concentration–time profiles of once-yearly intramuscular lenacapavir versus twice-yearly subcutaneous lenacapavir for formulation 1 (A) and formulation 2 (B). Credit: The Lancet (2025). DOI: 10.1016/S0140-6736(25)00405-2
A team of pharmaceutical researchers at biopharma company Gilead Sciences has announced that a reformulation of its HIV prevention drug lenacapavir allows it to persist in the body for up to a year. In their paper published in The Lancet journal, the group describes how they injected the new formulation into several HIV-free volunteers and tested them for up to a year, and what they found in doing so.
Despite massive progress made in developing drugs to prevent HIV infections over the past several decades, millions of people are still infected every year, with many developing AIDs and dying. This, the researchers note, is because so many people still do not have access to such drugs, or those used to treat the disease once infected.
It has been noted by some in the research field that if prevention drugs did not require daily, or even monthly dosages, treatment adherence would likely increase. Because of that, researchers around the world have been looking at increasing the time between pre-exposure prophylaxis (PrEP) injections.
Last year, a team at Gilead announced that they had developed a PrEP called lenacapavir that could provide complete protection against HIV infections with injections every six months.
In this latest announcement, the team at Gilead has announced that a reformulation of lenacapavir may extend the time between shots to an entire year.
The new reformulation is still undergoing testing to ensure it provides the same protection as its six-month variety. Testing thus far has involved injecting 40 HIV-negative volunteers and monitoring them to see how long the drug persists in their bodies. Thus far, the researchers have found it still present for up to 56 weeks. They also found that it caused no major side effects or presented any concerns about the safety of the volunteers.
The research team plans to conduct additional trials soon using a more diverse group of volunteers and, over time, show that it is just as effective as the six-month variety. They conclude by suggesting that if their drug is eventually found safe and effective, it could help to slow or even stop the HIV epidemic.
More information:
Vamshi Jogiraju et al, Pharmacokinetics and safety of once-yearly lenacapavir: a phase 1, open-label study, The Lancet (2025). DOI: 10.1016/S0140-6736(25)00405-2
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Reformulation of HIV prevention drug lenacapavir makes it last for a year (2025, March 12)
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