On December 12, 2024, the top ten scientific breakthroughs of the year in Science magazine arrived as expected. An AIDS drug, Lenacapavir, was named the top scientific breakthrough of the year. The drug only needs to be injected once every 6 months and has achieved remarkable success in preventing HIV infection, which is expected to help end the HIV/AIDS epidemic.

The interim analysis data of the key Phase 3 clinical trial released by Gilead Sciences showed that twice-yearly dosing achieved 100% AIDS prevention effect in women.

On June 20, 2024, Gilead Sciences announced the interim analysis results of its key Phase 3 clinical trial of Lenacapavir, an AIDS prevention drug, showing that only twice-yearly dosing achieved 100% AIDS prevention effect in women.

It is reported that this project is the most comprehensive and diverse AIDS prevention trial project ever conducted. Dr. Merdad Parsey, Gilead's Chief Medical Officer, said that two doses of Lenacapavir per year had 0 infections and 100% prevention, demonstrating its potential as an important new tool to help prevent HIV infection. We look forward to more results from ongoing clinical trials and further achieving our goal of helping everyone around the world end the HIV epidemic.

Lenacapavir (trade name Sunlenca) is an antiretroviral drug developed by Gilead. It is an HIV-1 capsid inhibitor and was approved by the US FDA in 2022 for the treatment of HIV/AIDS. Its mechanism of action is to directly bind to the interface between the HIV-1 viral capsid protein (p24) subunits, interfering with key steps in the viral replication process, including capsid-mediated nuclear uptake of HIV-1 proviral DNA, viral assembly and release, capsid protein subunit production, and capsid core formation.

In this phase 3, double-blind, randomized controlled clinical trial (project codenamed PURPOSE 1), the research team evaluated the safety and efficacy of Lenacapavir for pre-exposure prevention (PrEP) of HIV infection. More than 5,300 women aged 16-25 from 25 sites in South Africa and 3 sites in Uganda participated in this clinical study. They were randomly assigned to receive Lenacapavir (subcutaneous injection twice a year), Descovy (oral daily) and Truvada (oral daily) in a 2:2:1 ratio.

The results showed that among the 134 women in the Lenacapavir group, there were no new cases of HIV infection (incidence rate of 0.00 cases/100 person-years). There were 16 new cases among 1,068 women in the Truvada group (incidence rate of 1.69 cases/100 person-years). There were 39 cases among 2,136 women in the Descovy group (incidence rate of 2.02 cases/100 person-years). During the trial, Lenacapavir was generally well tolerated, and no significant or new safety issues were found. Gilead will release more detailed data later.

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