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

What this Trial Is About

Chronic Hepatitis B virus HBV infection is a significant public health issue in China. Current treatments with interferon alpha IFNb1 or nucleostide analogues NAs achieve sustained loss of Hepatitis B surface antigen HBsAg in less than 10% of patients. Previous research increased this rate to 15% overall and up to 30-50% in patients with lower HBsAg levels using a sequential combination therapy. This trial aims to further improve this functional cure rate by combining immune checkpoint inhibitors targeting the PD-1PD-L1 pathway with IFNb1 to restore T cell function and enhance immune control against HBV. Participants will receive one of two treatment combinations NAs plus anti-PD-1 antibody with Peg-IFNb1, or NAs plus Peg-IFNb1 alone. The anti-PD-1 antibody is administered subcutaneously or intravenously at intervals of one to three weeks at doses lower than those used for cancer. NAs are taken orally once daily, and Peg-IFNb1 is given as a weekly subcutaneous injection. This large multicenter prospective study will evaluate safety, efficacy, and rates of HBsAg loss compared to previous studies. During the study, participants will undergo regular assessments including blood tests for HBsAg, HBV DNA levels, and liver enzyme alanine aminotransferase ALT at baseline, 24 weeks, 48 weeks, and 24 weeks after treatment ends. Researchers will monitor immune response and safety throughout the trial. The study duration and follow-up will allow evaluation of long-term effects and the potential for a clinical cure to reduce the burden of HBV infection toward global elimination goals by 2030.

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