Clinical trial: comparison of weekly once versus twice half-dose weekly administration of pegylated interferon alpha 2b in combination with ribavirin for the treatment of HCV-1 positive patients with chronic hepatitis C

Aliment Pharmacol Ther. 2007 Oct 1;26(7):1077-82. doi: 10.1111/j.1365-2036.2007.03451.x.

Abstract

Background: Pegylated interferon (PEG-IFN) alpha2b is currently used as a once weekly injection in combination with ribavirin for the treatment of chronic hepatitis C.

Aim: To test whether twice half-dose weekly administration may improve the virological response in difficult-to-treat hepatitis C virus-1 patients.

Methods: Thirty patients were treated with 1.5 microg/kg of PEG-IFN alpha2b given once weekly for 48 weeks (group A) and were compared with 30 patients treated with the same dose of PEG-IFN alpha2b divided in twice weekly doses of 0.75 microg/kg for the initial 4 weeks (group B). All patients were hepatitis C virus-1 positive and received weight-based ribavirin (800-1400 mg/daily).

Results: Weekly twice half-dose administration of PEG-IFN alpha2b for the first 4 weeks was associated with lower rates of biochemical and virological response at all time points compared with a once weekly schedule, and with significantly higher rates of in-therapy breakthrough leading to significantly lower rates of end of therapy response (week 48). The rate of sustained virological response was of 56.7% in group A and 36.7% in group B.

Conclusions: Weekly twice half-dose administration of PEG-IFN alpha2b is not superior to the standard once weekly schedule, and might be less efficacious.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adult
  • Antiviral Agents / pharmacokinetics
  • Antiviral Agents / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Injections
  • Interferon alpha-2
  • Interferon-alpha / pharmacokinetics
  • Interferon-alpha / therapeutic use*
  • Male
  • Polyethylene Glycols
  • Predictive Value of Tests
  • Recombinant Proteins
  • Ribavirin / pharmacokinetics
  • Ribavirin / therapeutic use*
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • peginterferon alfa-2b