Efficacy and safety of entecavir, peginterferon alfa-2b and GM-CSF combination therapy: the anchor randomized controlled trial.

ABSTRACT:

Background and aim

Functional cure is considered the advanced treatment goal for patients with chronic hepatitis B (CHB). We aimed to evaluate hepatitis B surface antigen (HBsAg) loss rates after combination treatment of entecavir (ETV) and peginterferon alfa-2b (Peg-IFN) with or without granulocyte-macrophage colony-stimulating factor (GM-CSF).

Methods

In this randomized controlled trial, virally suppressed patients undergoing nucleos(t)ide analogs with HBsAg < 3000 IU/mL were randomized 1:1:1 to receive either ETV for 96 weeks (E group), or 48 weeks of Peg-IFN + ETV, followed by 48-week Peg-IFN alone (EP group), or 48 weeks of Peg-IFN + ETV + GM-CSF, followed by 48-week Peg-IFN alone (EPG group). The primary outcome is HBsAg loss at week 96.

Results

Among 249 patien

SUBMITTER: Wu D 

PROVIDER: S-EPMC12923447 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature