title: [High sustained virological response to optimized therapy for refractory chronic hepatitis C treatment-na(i)ve patients: a multicenter randomized study].
abstract: OBJECTIVE
  To perform a prospective,multicenter,open,randomized study to determine a treatment regimen for treatment-naive patients with refractory chronic hepatitis C (RHC) using the predictive value (PV) of early virological response (EVR).
  
  
  METHODS
  A total of 438 patients from 18 hospitals were recruited between December 2008 and December 2010 and administered peg-interferon/ribavirin treatment for 12 weeks. Patients who achieved complete EVR (cEVR) were assigned to group A for a 48-week course of treatment, while patients without cEVR were randomly allocated to either group B 1 for a 72-week course of treatment or to group B2 for a 96-week course of treatment. Serum hepatitis C virus RNA levels at baseline,treatment weeks 4, 12 and 24, end of treatment, and post-treatment week 24 were measured and used to evaluate the efficiency of therapy.
  
  
  RESULTS
  The overall sustained virological response (SVR) rate was 85.1%. In all, 91.0% of patients achieved cEVR and were assigned to group A, which had an SVR rate of 90.8%. There was no statistically significant difference in the SVR rates of groups B1 and B2 (29.4% vs. 25.0%, P more than 0.05). The positive PV of rapid virological response (RVR), cEVR and delayed virological response (DVR) for SVR was 93.4%, 90.8% and 77.8% respectively, and the negative PV of RVR, EVR and DVR for SVR was 28.0%, 93.3% and 100% respectively. Overall, 66.9% of the patients experienced adverse events (AEs), but only 1.9% of patients experienced sevcre AEs.
  
  
  CONCLUSIONS
  The majority of Chinese RHC treatmentna(i)ve patients (91.0%) can achieve cEVR and a high SVR rate with a low rate of severe AEs using the cEVR guided personal treatment regimen.
authors.affiliation: International Medical Department, Youan Hospital, Capital Medical University, Beijing 100069, China.
authors.forename: Xinyue
authors.initials: X
authors.lastname: Chen
authors.forename: Jia
authors.initials: J
authors.lastname: Shang
authors.forename: Ruifeng
authors.initials: R
authors.lastname: Yang
authors.forename: Qing
authors.initials: Q
authors.lastname: Xie
authors.forename: Zhiliang
authors.initials: Z
authors.lastname: Gao
authors.forename: Xiaoyuan
authors.initials: X
authors.lastname: Xu
authors.forename: Xiaoguang
authors.initials: X
authors.lastname: Dou
authors.forename: Guozhong
authors.initials: G
authors.lastname: Gong
authors.forename: Guofeng
authors.initials: G
authors.lastname: Chen
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Hong
authors.initials: H
authors.lastname: Chen
authors.forename: Dazhi
authors.initials: D
authors.lastname: Zhang
authors.forename: Yinong
authors.initials: Y
authors.lastname: Feng
authors.forename: Junqi
authors.initials: J
authors.lastname: Niu
authors.forename: Jinlin
authors.initials: J
authors.lastname: Hou
authors.forename: Hong
authors.initials: H
authors.lastname: You
authors.forename: Yun
authors.initials: Y
authors.lastname: Wu
authors.forename: Peili
authors.initials: P
authors.lastname: Zhao
authors.forename: Huiying
authors.initials: H
authors.lastname: Rao
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
mesh_terms: D000998:Antiviral Agents; D044466:Asian People; D004359:Drug Therapy, Combination; D019698:Hepatitis C, Chronic; D006801:Humans; D012254:Ribavirin
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin