Safety and efficacy of PD-1 antibody combined with pegylated interferon α for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial.

ABSTRACT:

Introduction

The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients b

SUBMITTER: Wang H 

PROVIDER: S-EPMC12458774 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature