Gilead Sciences presents first clinical data for once-yearly lenacapavir for HIV prevention

Gilead Sciences presents first clinical data for once-yearly lenacapavir for HIV prevention

In a groundbreaking development, Gilead Sciences, a leading biopharmaceutical company, has presented the first clinical data for a once-yearly formulation of lenacapavir, its long-acting antiretroviral drug, for HIV prevention [1]. If successful, this could revolutionize HIV prevention, offering individuals a convenient, effective, and potentially more adherent option.

Last year, Gilead announced that lenacapavir provided nearly complete protection against HIV infection with just a single injection every six months [1]. This breakthrough, currently under regulatory review, has been hailed as the closest thing the field has ever had to an HIV vaccine. Recently, Gilead published early data suggesting that a new formulation of the drug could be used to prevent infection with just a single shot per year [1].

The study, published in The Lancet, did not test the new formulation's efficacy in preventing HIV. Instead, it compared the drug levels in the blood of volunteers who received two different proposed formulations. The results showed that volunteers who received either new formulation had higher levels of drug in their bloodstream for 56 weeks than those receiving once-every-six-month injections [1]. This suggests that the new medicine should provide equal protection.

Howard Gendelman, who develops long-acting antiretrovirals, commented, "The data shatter a glass ceiling and could pave a path toward once-yearly medicines for both HIV and other diseases" [1]. However, Gilead must prove the safety and efficacy of the once-a-year formulation in a larger study before it can be approved for use.

Jared Baeten, Gilead's senior vice president of clinical development and virology, stated that the company was still reviewing the data to select an optimal formulation and dose [1]. Gilead plans to begin a Phase 3 trial of the once-a-year version this year but has not yet determined the study's design [1].

As the HIV prevention field faces an uncertain future, lenacapavir's potential as a once-yearly treatment could offer a promising solution. With ongoing research and development, this groundbreaking drug could provide individuals with a more convenient, effective, and potentially more adherent option for HIV prevention.

References:
[1] https://www.statnews.com/2025/03/11/hiv-prep-gilead-once-yearly-shot-lenacapavir/