title: Failure to achieve 2-log10 viral decrease in first four weeks of peg-IFNalpha-2b plus ribavirin therapy for chronic hepatitis C with genotype 1b and high viral titer is useful in predicting non-response: evaluation of response-guided therapy.
abstract: OBJECTIVE
  To clarify clinical parameters predicting sustained viral response (SVR) during 48 weeks pegylated-interferon (peg-IFN)alpha-2b plus ribavirin therapy for Japanese patients with chronic hepatitis C [CH(C)] genotype 1b and high viral titers.
  
  
  METHODS
  One hundred and fifty-one (151) patients receiving peg-IFNalpha-2b plus ribavirin therapy for 48 weeks were enrolled. SVR and clinical parameters were evaluated. The relationship between virological parameters (substitutions in the core and NS5A) and the degree of early viral decrease was also studied.
  
  
  RESULTS
  Seventy (46.4%) patients achieved SVR (per protocol analysis). Negative predictive value (NPV) of <2-log10 decrease after 4 weeks of therapy for SVR was 78.0%; similar to that for failing to achieve early viral response (EVR) at 12 weeks (82.2%).
  
  
  CONCLUSIONS
  Failure to achieve 2- log10 decrease in the first 4 weeks may be an important predictor of non-SVR during 48 weeks of peg-IFNalpha-2b plus ribavirin therapy; thus, therapeutic plans should be reassessed at that point.
authors.affiliation: Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Japan. okoshi@med.niigata-u.ac.jp
authors.forename: Shogo
authors.initials: S
authors.lastname: Ohkoshi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yamagiwa
authors.forename: Masahiko
authors.initials: M
authors.lastname: Yano
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Takahashi
authors.forename: Yoh-hei
authors.initials: YH
authors.lastname: Aoki
authors.forename: Nobuo
authors.initials: N
authors.lastname: Waguri
authors.forename: Kentaro
authors.initials: K
authors.lastname: Igarashi
authors.forename: Soh-ichi
authors.initials: S
authors.lastname: Sugitani
authors.forename: Tohru
authors.initials: T
authors.lastname: Takahashi
authors.forename: Tohru
authors.initials: T
authors.lastname: Ishikawa
authors.forename: Tomoteru
authors.initials: T
authors.lastname: Kamimura
authors.forename: Hiroto
authors.initials: H
authors.lastname: Wakabayashi
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Watanabe
authors.forename: Yasunobu
authors.initials: Y
authors.lastname: Matsuda
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Aoyagi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage*; D054357:Chemokine CXCL10 / Q000097:blood; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000998:Antiviral Agents; C114753:CXCL10 protein, human; D054357:Chemokine CXCL10; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b