title: Prediction of sustained response to low-dose pegylated interferon alpha-2b plus ribavirin in patients with genotype 1b and high hepatitis C virus level using viral reduction within 2 weeks after therapy initiation.
abstract: OBJECTIVE
  Continuation of pegylated interferon (PEG-IFN) plus ribavirin at the recommended dose is difficult in elderly patients and/or patients with cytopenia or complications. Whether the therapeutic efficacy of low-dose PEG-IFN plus ribavirin therapy could be predicted based on virological response within 2 weeks of therapy initiation was evaluated.
  
  
  METHODS
  A total of 106 patients with a high viral load of genotype-1b hepatitis C virus (HCV) underwent low-dose PEG-IFN plus ribavirin therapy. PEG-IFN alpha 2b (0.75 µg/kg per week) and ribavirin (600-800 mg/day) were administered for 48 weeks.
  
  
  RESULTS
  Sustained virological response (SVR) was achieved in 37%, and treatment was discontinued in 9%. On univariate analysis of SVR-contributing factors, significant differences were noted in the white blood cell count, platelet count, fibrosis markers, and viral reduction within 2 weeks from therapy initiation. On multivariate analysis, the platelet count and the reduction in the HCV core antigen level at week 2 were independent factors. The positive predictive value (PPV) and the negative predictive value (NPV) for SVR based on a 1-log or greater HCV-RNA level reduction at week 2 were 65% and 90%, respectively, and those based on HCV core antigen level at week 2 were 64% and 97%, respectively. PPV and NPV based on a 2-log or greater reduction of the RNA level were 86% and 67%, respectively, and those based on the core antigen level were 93% and 69%, respectively.
  
  
  CONCLUSIONS
  Evaluation of viral reduction at week 2 after therapy initiation is useful for predicting SVR to low-dose PEG-IFN plus ribavirin therapy.
authors.affiliation: Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan.
authors.forename: Hideyuki
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authors.lastname: Tamai
authors.forename: Naoki
authors.initials: N
authors.lastname: Shingaki
authors.forename: Tatsuya
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authors.lastname: Shiraki
authors.forename: Hiroshi
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authors.lastname: Tukuda
authors.forename: Yoshiyuki
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authors.lastname: Mori
authors.forename: Kosaku
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authors.lastname: Moribata
authors.forename: Shotaro
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authors.lastname: Enomoto
authors.forename: Hisanobu
authors.initials: H
authors.lastname: Deguchi
authors.forename: Kazuki
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authors.lastname: Ueda
authors.forename: Izumi
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authors.lastname: Inoue
authors.forename: Takao
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authors.lastname: Maekita
authors.forename: Mikitaka
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authors.lastname: Iguchi
authors.forename: Kimihiko
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authors.lastname: Yanaoka
authors.forename: Masashi
authors.initials: M
authors.lastname: Oka
authors.forename: Masao
authors.initials: M
authors.lastname: Ichinose