Efficacy and safety of interferon alpha-2b versus pegylated interferon alpha-2a monotherapy in children with chronic hepatitis B: a real-life cohort study from Shanghai, China.

Background: Interferon alpha (IFN-α) is a preferred therapy for antiviral treatment of children with chronic hepatitis B (CHB) aged > 1 year currently. Peginterferon alpha-2a (Peg-IFN α-2a) is a recommended international guideline for treatment of CHB children, which is limited to children aged > 3 years. But the exact efficacy and safety of IFN-α and Peg-IFN α-2a for treating CHB are not sufficient.

Methods: Clinical manifestations, baseline characteristics, related laboratory tests and adverse events were retrospectively analyzed in children with CHB, who visited Children's Hospital of Fudan University and were treated with IFN α-2b or Peg-IFN α-2a monotherapy and followed up from January 2003 to October 2018.

Results: A total of 36 immune-active patients without advanced fibrosis were enrolled to be treated with IFN α-2b (group A, n = 18) or Peg-IFN α-2a (group B, n = 18). IFN α-2b or Peg-IFN α-2a was administered for a median of 48 weeks subcutaneously by body surface area (BSA) category at a dose of 3 MU/m or 104 μg/m, respectively. HBV e antigen (HBeAg) seroconversion rates at 48 weeks post-treatment were higher in group A than group B (92.9% vs. 87.5%), so as the rates of HBsAg clearance (22.2% vs. 11.1%), and hepatitis B virus (HBV)-DNA < 1000 IU/mL (88.9% vs. 83.3%). Only mild flu-like symptoms and transient neutropenia appeared in some children at the early stage of treatment. No severe abnormal results was observed in other laboratory assessments.

Conclusion: The antiviral monotherapy of 48-week IFN α-2b or Peg-IFN α-2a in children with CHB is well tolerated and effective, which is associated with higher rates of HBeAg seroconversion and HBsAg clearance than in adults and previously pediatric patients.