title: Relevance of the Core 70 and IL-28B polymorphism and response-guided therapy of peginterferon alfa-2a ± ribavirin for chronic hepatitis C of Genotype 1b: a multicenter randomized trial, ReGIT-J study.
abstract: BACKGROUND
  We conducted a multicenter randomized clinical trial to determine the optimal treatment strategy against chronic hepatitis C virus (HCV) with genotype 1b and a high viral load (G1b/high).
  
  
  METHODS
  The study subjects included 153 patients with G1b/high. Patients were initially treated with PEG-IFNα-2a alone and then randomly assigned to receive different treatment regimens. Ribavirin (RBV) was administered to all patients with HCV RNA at week 4. Patients negative for HCV RNA at week 4 were randomly assigned to receive PEG-IFNα-2a (group A) or PEG-IFNα-2a/RBV (group B). Patients who showed HCV RNA at week 4 but were negative at week 12 were randomly assigned to receive weekly PEG-IFNα-2a (group C) or biweekly therapy (group D). Patients who showed HCV RNA at week 12 but were negative at week 24 were randomly assigned to receive PEG-IFNα-2a/RBV (group E) or PEG-IFNα-2a/RBV/fluvastatin (group F).
  
  
  RESULTS
  Overall, the rate of sustained virological response (SVR) was 46 % (70/153). The total SVR rate in the group (A, D, and F) of response-guided therapy was significantly higher than that in the group (B, C, and E) of conventional therapy [70 % (38/54) versus 52 % (32/61), p = 0.049]. Although IL28-B polymorphism and Core 70 mutation were significantly associated with efficacy, patients with rapid virological response (RVR) and complete early virological response (cEVR) achieved high SVR rates regardless of their status of IL-28B polymorphism and Core 70 mutation.
  
  
  CONCLUSIONS
  In addition to knowing the IL-28B polymorphism and Core 70 mutation status, understanding the likelihood of virological response during treatment is critical in determining the appropriate treatment strategy.
authors.affiliation: Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan, nishiguc@hyo-med.ac.jp.
authors.forename: Shuhei
authors.initials: S
authors.lastname: Nishiguchi
authors.forename: Hirayuki
authors.initials: H
authors.lastname: Enomoto
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Aizawa
authors.forename: Hiroki
authors.initials: H
authors.lastname: Nishikawa
authors.forename: Yukio
authors.initials: Y
authors.lastname: Osaki
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Tsuda
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
authors.forename: Kazuichi
authors.initials: K
authors.lastname: Okazaki
authors.forename: Toshihito
authors.initials: T
authors.lastname: Seki
authors.forename: Soo Ryang
authors.initials: SR
authors.lastname: Kim
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Hongo
authors.forename: Hisato
authors.initials: H
authors.lastname: Jyomura
authors.forename: Naoshi
authors.initials: N
authors.lastname: Nishida
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Kudo
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D007372:Interferons; D007378:Interleukins / Q000235:genetics*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D011110:Polymorphism, Genetic; D012367:RNA, Viral; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D000095022:Interferon Lambda
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D007372:Interferons; D007378:Interleukins; D011092:Polyethylene Glycols; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; C000624353:interferon-lambda, human; D000095022:Interferon Lambda; C100416:peginterferon alfa-2a
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