90% of Patients Achieve Viral Suppression in Gilead's Phase I Study of Long-Acting Triple-Combination HIV Therapy

On February 22, Gilead Sciences announced Phase I study data on the treatment of HIV infection using the HIV capsid protein inhibitor lenacapavir in combination with two broadly neutralizing antibodies (bNAbs), Teropavimab and Zinlirvimab. The study results showed that the triple-combination therapy, administered once every six months, demonstrated good safety and efficacy in HIV-infected patients.

Lenacapavir is a first-in-class long-acting HIV capsid inhibitor that inhibits HIV-1 replication by interfering with multiple critical steps in the viral life cycle, including the inhibition of HIV-1 proviral DNA uptake, assembly, and release mediated by the viral capsid, as well as the formation of the viral capsid core, with no known cross-resistance to other existing drug classes.

This Phase I study enrolled 20 HIV-infected individuals who had been fully suppressed (HIV-1 RNA <50 copies/mL) for two years after receiving antiretroviral therapy (ART). They were treated with lenacapavir (927 mg sublingual) + Teropavimab (30 mg/kg intravenous infusion) + Zinlirvimab (various doses intravenous infusion).

The study results showed that at 26 weeks of treatment, 90% of patients (n=18/20) had complete HIV viral suppression.At week 12 of treatment, one patient withdrew from the trial with HIV fully suppressed. At week 16 of treatment, one patient experienced HIV viral rebound but was re-suppressed after resuming ART. In terms of safety, there were no serious adverse events (no grade 4 or 5 adverse events) and no discontinuations due to adverse reactions.

The detailed results of the study will be presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI). Based on the positive results from the Phase I study, Gilead Sciences will advance the triple combination therapy into Phase II studies later this year.

Dr. Jared Baeten, Vice President of Gilead's HIV Clinical Development, stated: "We are particularly excited about the potential of lenacapavir in combination with bNAbs as a twice-yearly treatment for HIV. We remain committed to exploring innovative treatment options that can help all individuals living with HIV."

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Live Broadcast

CUBE LIVE