Subcutaneously administered recombinant human beta-interferon in the treatment of chronic hepatitis B virus infection

Aliment Pharmacol Ther. 1996 Oct;10(5):807-14. doi: 10.1046/j.1365-2036.1996.47189000.x.

Abstract

Background: Treatment of chronic replicative hepatitis B virus (HBV) infection is aimed at stopping viral replication and preventing the development of chronic liver disease. beta-Interferon treatment has been less well studied than alpha-interferon.

Methods: The efficacy and tolerability of a 6-month course of subcutaneously administered human recombinant beta-interferon (rINF-beta ser) was studied and the results of a low-dose regime compared with a high-dose regime. Twenty patients (17 men and three women), aged 24-54 years, with chronic hepatitis B virus infection (all hepatitis B surface antigen-positive with detectable HBV-DNA in their sera for at least 3 months prior to therapy) were randomized into two treatment groups of 10 patients each. The low-dose group received 6 x 10(6) U/dose and the high-dose group received 30 x 10(6) U/dose, both groups receiving their respective doses three times a week initially for 1 month and continuing for a total of 6 months.

Results: The treatment was well tolerated in both groups. None of the patients required dosage reduction or cessation of treatment because of side-effects. HBV-DNA decreased in all patients during treatment, demonstrating the anti-viral efficacy of rINF-beta ser, and was undetectable in 20 and 40% of patients receiving low-dose and high-dose regimes, respectively, at the end of 6 months treatment (P = N.S.). One year after completion of treatment, HBV-DNA was undetectable in 50 and 30% of patients in the low-dose and high-dose groups, respectively (P = N.S.). However, only one patient achieved seroconversion with loss of the hepatitis B surface antigen and appearance of an antihepatitis B 'e' antigen at the end of 18 months.

Conclusion: This study shows that subcutaneously administered rINF-beta ser is well tolerated, but the optimal dose and duration of treatment still needs to be defined by further studies.

Publication types

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

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / pharmacology
  • Antiviral Agents / therapeutic use*
  • Autoradiography
  • Blood Chemical Analysis
  • Dose-Response Relationship, Drug
  • Female
  • Hepatitis B / drug therapy*
  • Hepatitis B Surface Antigens
  • Hepatitis B virus / drug effects*
  • Humans
  • Immunoenzyme Techniques
  • Injections, Subcutaneous
  • Interferon-beta / administration & dosage
  • Interferon-beta / pharmacology
  • Interferon-beta / therapeutic use*
  • Male
  • Middle Aged
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / pharmacology
  • Recombinant Proteins / therapeutic use*
  • Transaminases / blood
  • Transaminases / metabolism

Substances

  • Antiviral Agents
  • Hepatitis B Surface Antigens
  • Recombinant Proteins
  • Interferon-beta
  • Transaminases