title: Eicosapentaenoic acid could permit maintenance of the original ribavirin dose in chronic hepatitis C virus patients during the first 12 weeks of combination therapy with pegylated interferon-alpha and ribavirin. A prospective randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy of eicosapentaenoic acid (EPA) against ribavirin (RBV)-associated hemolytic anemia during the first 12 weeks in chronic hepatitis C virus (HCV) combination therapy.
  
  
  METHODS
  This study was a prospective open-label, randomized controlled trial. 100 HCV patients were randomized to either the EPA group (n = 49) or non-EPA group (n = 51) who received combination therapy with or without EPA. We compared the changes in hemoglobin level and RBV plasma concentrations at week 12 in each group with RBV dose reduction rate and performed multivariate analysis to identify independent variables associated with RBV dose reduction.
  
  
  RESULTS
  8 patients (17%) in the EPA group and 20 patients (29%) in the non-EPA group required RBV dose reduction, respectively. The cumulative RBV reduction rate was significantly lower in the EPA group than in the non-EPA group (p = 0.017), while the decrease of hemoglobin and RBV plasma concentrations from baseline was not significantly different. However, in the multivariate analysis, treatment with EPA showed significant variables for the reduction of RBV dose (odds ratio 3.235, p = 0.023).
  
  
  CONCLUSIONS
  EPA could prevent the RBV dose reduction during the first 12 weeks in combination therapy, although further large-scale double-blind randomized controlled trials are required.
authors.affiliation: Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Takaki
authors.forename: Yoshiiku
authors.initials: Y
authors.lastname: Kawakami
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: Hiroto
authors.initials: H
authors.lastname: Ishihara
authors.forename: Keiji
authors.initials: K
authors.lastname: Tsuji
authors.forename: Shiomi
authors.initials: S
authors.lastname: Aimitsu
authors.forename: Hiroiku
authors.initials: H
authors.lastname: Kawakami
authors.forename: Toshio
authors.initials: T
authors.lastname: Nakanishi
authors.forename: Mikiya
authors.initials: M
authors.lastname: Kitamoto
authors.forename: Takashi
authors.initials: T
authors.lastname: Moriya
authors.forename: Kenichi
authors.initials: K
authors.lastname: Satoh
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Chayama
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy; D004359:Drug Therapy, Combination; D015118:Eicosapentaenoic Acid / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000276:immunology; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D015118:Eicosapentaenoic Acid; C100416:peginterferon alfa-2a