title: Prediction of efficacy to pegylated interferon-α-2b plus ribavirin in patients with genotype 2 hepatitis C virus using viral response within 2 weeks.
abstract: OBJECTIVE
  Rapid virological response (RVR), defined as serum hepatitis C virus (HCV) RNA negativity at 4 weeks, is the most useful predictor of sustained virological response (SVR) to standard pegylated interferon (PEG IFN) plus ribavirin therapy for patients infected with genotype 2 HCV. The aim of the present study was to predict SVR using viral response within 2 weeks of therapy initiation.
  
  
  METHODS
  Of 64 HCV genotype 2 patients with a high viral load treated with standard PEG IFN-α-2b plus weight-based ribavirin for 24 weeks, 58 patients whose adherence was more than 67% were analyzed. RNA and core antigen levels were measured at four time points: the day of therapy initiation, the following day, and at 1 and 2 weeks.
  
  
  RESULTS
  SVR was achieved in 73% (47/64) of patients. Univariate analysis of SVR contributing factors showed significant differences with age, bodyweight, white blood cell count, platelet count, fibrosis marker levels, baseline core antigen level and viral response. The area under the receiver-operator curve (AUC) of the core antigen level at 1 week (AUC, 0.940) was the highest among the significant SVR predicting factors. Setting 100 fmol/L as the cut-off value for core antigen level at 1 week, the sensitivity, specificity, positive predictive value, negative predictive value and accuracy for predicting SVR were 100%, 86%, 96%, 100% and 97%, respectively, and for predicting RVR were 66%, 93%, 97%, 46% and 72%, respectively.
  
  
  CONCLUSIONS
  The HCV core antigen level at 1 week after therapy initiation is the most useful predictor for SVR.
authors.affiliation: Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Wada
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Tamai
authors.forename: Akiko
authors.initials: A
authors.lastname: Uno
authors.forename: Akira
authors.initials: A
authors.lastname: Kawashima
authors.forename: Naoki
authors.initials: N
authors.lastname: Shingaki
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Mori
authors.forename: Kosaku
authors.initials: K
authors.lastname: Moribata
authors.forename: Kaori
authors.initials: K
authors.lastname: Miyata
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higashi
authors.forename: Hisanobu
authors.initials: H
authors.lastname: Deguchi
authors.forename: Kazuki
authors.initials: K
authors.lastname: Ueda
authors.forename: Izumi
authors.initials: I
authors.lastname: Inoue
authors.forename: Takao
authors.initials: T
authors.lastname: Maekita
authors.forename: Mikitaka
authors.initials: M
authors.lastname: Iguchi
authors.forename: Jun
authors.initials: J
authors.lastname: Kato
authors.forename: Masao
authors.initials: M
authors.lastname: Ichinose
keywords: hepatitis C core antigen; pegylated interferon-α-2b; prediction; ribavirin; sustained virological response