Dual-centre, double-blind, randomised trial of lymphoblastoid interferon alpha with or without steroid pretreatment in children with chronic hepatitis B

Liver. 1995 Jun;15(3):143-8. doi: 10.1111/j.1600-0676.1995.tb00661.x.

Abstract

Thirty-five children with chronic HBV infection, HBV-DNA and eAg serum positivity, and HBcAg in liver tissue were treated with lymphoblastoid human interferon alpha with (16 cases) or without (19 cases) prednisolone pretreatment. The patients were double-blind randomized to receive steroid or placebo for 4 weeks, followed after 2 weeks by 5 or 10 MU/m2 interferon for 12 weeks. The e anti-e seroconversion rate reached 48%, which is much higher than the spontaneous seroconversion rate. The influence of "prednisolone priming" was not statistically significant. HBeAg clearance was similar in both groups (44% after prednisolone/interferon and 53% after interferon alone). The response to either treatment did not correlate with the pretreatment serum transaminase. HBV-DNA or degree of histological activity. Interferon was well tolerated, the side effects being less severe than in adults, and never led to suspension of the treatment.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Biopsy
  • Child
  • Child, Preschool
  • Chronic Disease
  • DNA, Viral / analysis
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Hepatitis B / drug therapy*
  • Hepatitis B / metabolism
  • Hepatitis B Surface Antigens / analysis
  • Humans
  • Interferon-alpha / therapeutic use*
  • Male
  • Prednisolone / therapeutic use*
  • Transaminases / metabolism

Substances

  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Interferon-alpha
  • Prednisolone
  • Transaminases