title: Dose comparison study of pegylated interferon-alpha-2b plus ribavirin in naïve Japanese patients with hepatitis C virus genotype 2: a randomized clinical trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of pegylated interferon (PEG-I) at 1 and 1.5 microg/kg, and in combination with ribavirin (RBV) for 24 weeks in naïve Japanese patients infected with hepatitis C virus genotype 2.
  
  
  METHODS
  The present study was an open-label, randomized trial of 55 patients receiving PEG-I (1 or 1.5 microg/kg body weight [BW], subcutaneously, once a week) and RBV for 24 weeks. The patients were followed up for 24 weeks without treatment.
  
  
  RESULTS
  The intention-to-treat analyses showed that the proportion of patients with a sustained virological response (SVR) in the 1-microg/kg PEG-I-RBV group (38.5%, 10/26) was lower than that of the 1.5-microg/kg PEG-I-RBV group (74.1%, 20/27; P = 0.013). The PEG-I dose was reduced in two of the 26 patients of the 1-microg/kg PEG-I-RBV group (one because of thrombocytopenia at 2 weeks, and one because of generalized fatigue at 20 weeks), and four of the 27 patients of the 1.5-microg/kg PEG-I-RBV group (one because of neutropenia at 20 weeks, and three because of generalized fatigue at 1, 5, and 8 weeks). The multivariate analysis identified age (< 60 years) and dose of PEG-I (1.5 microg/kg) as significant determinants of SVR.
  
  
  CONCLUSIONS
  The dose of PEG-I to be used at the start of therapy should be 1.5-microg/kg BW in naïve Japanese patients infected with hepatitis C virus genotype 2.
authors.affiliation: Department of Medicine and Molecular Science, Hiroshima University, Minami-ku, Hiroshima, Japan.
authors.forename: Tomokazu
authors.initials: T
authors.lastname: Kawaoka
authors.forename: Yoshiiku
authors.initials: Y
authors.lastname: Kawakami
authors.forename: Keiji
authors.initials: K
authors.lastname: Tsuji
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ito
authors.forename: Mikiya
authors.initials: M
authors.lastname: Kitamoto
authors.forename: Shiomi
authors.initials: S
authors.lastname: Aimitsu
authors.forename: Hiroiku
authors.initials: H
authors.lastname: Kawakami
authors.forename: Soo Cheol
authors.initials: SC
authors.lastname: Jeong
authors.forename: Michio
authors.initials: M
authors.lastname: Imamura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Aikata
authors.forename: Shoichi
authors.initials: S
authors.lastname: Takahashi
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Chayama
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b