Peginterferon alfa-2a/ribavirin in hepatitis C virus patients nontolerant or nonresponsive to peginterferon alfa-2b/ribavirin

Aliment Pharmacol Ther. 2008 Mar 1;27(5):433-40. doi: 10.1111/j.1365-2036.2007.03587.x. Epub 2007 Dec 10.

Abstract

Background: Peginterferon alfa-2a/ribavirin treatment resulted in fewer incidences of depression and flu-like symptoms than that of standard interferon/ribavirin, whereas peginterferon alfa-2b/ribavirin and standard interferon/ribavirin treatment resulted in similar incidences of these adverse events (AEs).

Aim: To assess the efficacy and safety of peginterferon alfa-2a/ribavirin in genotype 1-infected patients treated for up to 12 weeks with peginterferon alfa-2b/ribavirin but not achieving early virologic response (EVR) (non-EVR) or nontolerant (NT) because of depression, fatigue, flu-like symptoms, or injection-site reactions.

Methods: Nontolerants were treated for an additional 36 weeks and non-EVRs for an additional 60 weeks with peginterferon alfa-2a (180 microg/week)/ribavirin (1000/1200 mg/day). Patients with detectable HCV RNA after 12 weeks were discontinued.

Results: Of 25 NTs, 23 (92%) were HCV-RNA negative after 12 weeks on peginterferon alfa-2a/ribavirin and 14 (56%) achieved sustained virologic response. Of 32 non-EVRs to peginterferon alfa-2b/ribavirin, four (13%) achieved EVR with peginterferon alfa-2a/ribavirin and one (3%) achieved sustained virologic response. Four non-EVRs and 0 NTs were withdrawn for AEs; 26 (81%) and 24 (96%), respectively, completed peginterferon alfa-2a/ribavirin treatment or were withdrawn for insufficient response at week 12. In NTs, depression, fatigue, flu-like symptoms, and injection-site reactions declined during treatment.

Conclusion: Most patients who did not tolerate peginterferon alfa-2b/ribavirin because of AEs, and who completed the full 36-week course of peginterferon alfa-2a/ribavirin treatment, achieved sustained virologic response.

Trial registration: ClinicalTrials.gov NCT00087568.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anemia / chemically induced
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Depression / psychology
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Drug Tolerance*
  • Female
  • Hepacivirus / drug effects
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / genetics
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use*
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Neutropenia / chemically induced
  • Polyethylene Glycols / adverse effects
  • Polyethylene Glycols / therapeutic use*
  • RNA, Viral / drug effects
  • RNA, Viral / genetics
  • Recombinant Proteins
  • Ribavirin / adverse effects
  • Ribavirin / therapeutic use*
  • Surveys and Questionnaires
  • Thrombocytopenia / chemically induced
  • Time Factors
  • Viral Load

Substances

  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • peginterferon alfa-2b
  • peginterferon alfa-2a

Associated data

  • ClinicalTrials.gov/NCT00087568