Evaluating a New Combination Therapy Using Anti-PD-1 Antibody and Pegylated Interferon to Achieve Functional Cure in Adults with Chronic Hepatitis B

What This Trial Is About

Chronic Hepatitis B virus HBV infection remains a major health challenge in China. This research aims to improve the rate of functional cure, defined as sustained loss of Hepatitis B surface antigen HBsAg, which is achieved in less than 10% of patients with current antiviral therapies like interferon IFNb1 or nucleostide analogues NAs. Building on a previous study that combined IFNb1 with NAs to increase HBsAg loss, this trial explores a new combination including an immune checkpoint inhibitor anti-PD-1 antibody with IFNb1 to better reverse immune tolerance and boost cure rates. Participants receive one of two treatments either NAs combined with anti-PD-1 antibody and Pegylated IFNb1, or NAs combined with Pegylated IFNb1 alone. The anti-PD-1 antibody is given subcutaneously or intravenously every one to three weeks at doses lower than those used in cancer treatment. NAs are taken orally once daily, and Peg-IFNb1 is injected subcutaneously once a week. This large multicenter study aims to assess safety, immune response, and the effectiveness of this combination in increasing HBsAg loss beyond previous results. Throughout the study, participants will undergo regular blood tests measuring HBsAg, HBV DNA levels, and liver enzyme alanine aminotransferase ALT at baseline, 24 weeks, 48 weeks after treatment, and 24 weeks post-treatment. Safety and treatment effects will be closely monitored. The trial spans up to 48 weeks of treatment with follow-up evaluations, aiming to support the goal of reducing HBV burden and contributing to global hepatitis elimination efforts by 2030.

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