Evaluating a New Combination Therapy Using Anti-PD-1 Antibody and Nucleostide Analogues for Functional Cure in Chronic Hepatitis B

What This Trial Is About

Researchers are investigating a new combination treatment strategy aimed at achieving a functional cure for chronic hepatitis B virus HBV infection. Chronic hepatitis B is a significant public health issue, and current treatments using interferon or nucleostide analogues NAs achieve sustained loss of hepatitis B surface antigen HBsAg in less than 10% of patients. This study builds on previous work that increased HBsAg loss rates and aims to further improve these rates by reversing T cell exhaustion using immune checkpoint inhibitors, specifically anti-PD-1 antibodies. The study compares two groups one receiving a combination of NAs with an anti-PD-1 antibody followed by NAs alone, and the other receiving NAs monotherapy. The anti-PD-1 antibody is administered subcutaneously or intravenously once every one to three weeks at doses lower than those used in cancer treatment, while NAs are taken orally once daily. This approach seeks to restore immune control over HBV and increase the rate of functional cure beyond 50% in the overall patient population. Participants will be followed throughout the treatment and for 24 weeks after the end of treatment. Researchers will measure serum HBsAg, HBV DNA levels, and alanine aminotransferase ALT at baseline, 24 weeks and 48 weeks after treatment, and 24 weeks following treatment completion. The study is designed to monitor safety and efficacy, with the goal of reducing HBV burden and contributing to global hepatitis elimination targets by 2030.

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