Treatment of pegylated interferon-α2a in chronic hepatitis B patients demonstrating a spontaneous decline in HBV DNA after acute exacerbation

Background: Acute exacerbation (AE) in chronic hepatitis B (CHB) is usually followed by a spontaneous decline in HBV DNA levels. The subsequent treatment is controversial. In this study, we evaluated the efficacy and safety of pegylated interferon-alpha 2a (PEG-IFN-alpha 2a) for such CHB patients. Methods: A total of 74 hepatitis B e antigen (HBeAg)-positive patients with a spontaneous HBV DNA decline (by >2 log(10) IU.ml(-1), compared with baseline levels before antiviral treatment) after AE (alanine aminotransferase [ALT]: 10-30-fold the upper limit of normal [ULN], total bilirubin [TBIL]: 2-20 mg.dl(-1), prothrombin time activity >60%) were included. In total, 22 patients (group A) received PEG-IFN-alpha 2a treatment (180 mu g.kg(-1).week(-1), when ALT was <10 ULN and TBIL<2 mg.dl(-1)) for 48 weeks, with 48 weeks of treatment-free follow-up. Twenty-one patients (group B) selected continual entecavir therapy. Thirty-one patients (group C, control group) received routine liver-protective drugs. Results: At week 96, virological response rates were 90.5%, 100% and 48%, and ALT normalization rates were 81%, 95% and 40% for groups A, B and C, respectively. HBeAg seroconversion rates were 71.4%, 45% and 32% in groups A, B and C, respectively. A high hepatitis B surface antigen (HBsAg) loss rate was observed in PEG-IFN-alpha 2a-treated patients, while no entecavir- treated patients achieved HBsAg loss. Group A patients suffered from typical PEG-IFN therapy-related adverse events. No severe adverse event was observed in any groups. Conclusions: PEG-IFN-alpha 2a is effective and safe for treating CHB patients demonstrating a spontaneous decline in HBV DNA after AE, and yields an increased likelihood of HBsAg loss.