title: Peginterferon-alpha-2a (40kD) and ribavirin in patients with chronic hepatitis C: a phase II open-label study.
abstract: OBJECTIVE
  Addition of a 40kD polyethylene glycol moiety to interferon-alpha-2a [peginterferon-alpha-2a (40kD)] improves pharmacokinetic properties over those of standard interferon. We conducted a phase II study to assess the safety and initial efficacy of peginterferon-alpha-2a (40kD) plus ribavirin combination therapy in patients with chronic hepatitis C (CHC).
  
  
  METHODS
  Twenty patients received open-label 180 microg peginterferon-alpha-2a (40kD) subcutaneously once weekly and oral ribavirin 1000 or 1200mg daily for patients weighing <75 or > or =75kg, respectively, for a period of 24 weeks. Patients with hepatitis C virus (HCV) genotype 1 and a virological response at week 24 received study drugs for an additional 24 weeks.
  
  
  RESULTS
  A sustained virological response, defined as undetectable HCV RNA 24 (i.e. <100 copies/ml) weeks after completing the therapy, was achieved in 50% of patients in an intent-to-treat analysis (6/16 genotype 1 and 4/4 genotype non-1). Adverse events were similar to those reported with unmodified interferon plus ribavirin combination therapy. Anaemia led to ribavirin dose reduction in five patients. Neutropenia led to dose reduction in three patients treated with peginterferon-alpha-2a (40kD).
  
  
  CONCLUSIONS
  The addition of ribavirin to a once-weekly peginterferon-alpha-2a (40kD) regimen should be investigated in larger clinical trials.
authors: The Johns Hopkins University School of Medicine, 1830 East Monument Street, Rm 448, Baltimore, MD 21267-0003, USA. msulkows@jhmi.edu
authors: Mark
authors: M
authors: Sulkowski
authors: Robert
authors: R
authors: Reindollar
authors: David L
authors: DL
authors: Thomas
authors: Sherilyn
authors: S
authors: Brinkley-Laughton
authors: Martha
authors: M
authors: Hudson
authors: Jian
authors: J
authors: Yu
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a