A New Combination Treatment Using Anti-PD-1 Antibody and Nucleostide Analogues to Achieve Functional Cure in Adults with Chronic Hepatitis B

What this Trial Is About

Chronic Hepatitis B virus HBV infection poses a significant public health challenge, particularly in China. Current treatments with interferon or nucleostide analogues NAs achieve sustained Hepatitis B surface antigen HBsAg lossa functional curein less than 10% of patients. This study aims to explore a novel combination therapy that includes an immune checkpoint inhibitor anti-PD-1 antibody alongside NAs to improve the rate of HBsAg loss, targeting over 50% functional cure in treated patients. The research builds on previous findings and intends to restore immune control by reversing T cell exhaustion caused by HBV infection. Participants will receive either a combination of NAs plus anti-PD-1 antibody or NAs alone. The anti-PD-1 antibody is administered subcutaneously or intravenously once every one to three weeks at a dose lower than that used for cancer treatment, while NAs are taken orally once daily. The study is a phase 2, non-randomized clinical trial conducted across multiple centers and expects to compare safety and efficacy outcomes between these groups to assess the potential of immune checkpoint blockade in achieving higher rates of clinical cure. Throughout the study, participants will have their serum HBsAg, HBV DNA, and alanine aminotransferase ALT levels measured at baseline, 24 weeks, 48 weeks after treatment, and 24 weeks post-treatment to monitor response and safety. The study involves regular assessments over a treatment period followed by a post-treatment observation period. Participants will be monitored closely for adverse effects and treatment adherence, contributing to a comprehensive evaluation of this combination strategys impact on chronic HBV infection.

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)