title: Efficacy, tolerability and predictive factors for early and sustained virologic response in patients treated with weight-based dosing regimen of PegIFN alpha-2b ribavirin in real-life healthcare setting.
abstract: OBJECTIVE
  Increasing evidence to date highlights that individualized treatment regimens with pegylated interferon (PegIFN) and ribavirin represent a better approach for patients nowadays showing negative predictive factors for sustained virological response. The aims of this study were to assess the rate of early (EVR) and sustained virological response (SVR), tolerability and baseline predictive factors associated with EVR and SVR in patients with chronic hepatitis C treated with individualized weight-based dosing regimen for both PegIFN alpha-2b and ribavirin.
  
  
  METHODS
  The observational analysis included 234 consecutive patients with chronic hepatitis C genotype 1 treated with PegIFN alpha-2b and ribavirin on an out-patient basis between January 2003-March 2006.
  
  
  RESULTS
  The mean age of the study group was 49.5 years, and 35% were male patients; the group was slightly overweight (mean BMI=26.5 kg/sq.m). EVR was achieved in 84.6% (198/234 patients). The end-of-treatment and sustained biochemical responses were 76.3% and 66.1%, respectively. At the end of follow-up, an overall intent-to-treat SVR was achieved by 71 of 127 patients (in 55.9%). Lower baseline (< 1,000 000 IU/mL) HCV viral load was the only predictive factor associated with EVR (p=0.04); absent or mild fibrosis (F0-1) and a low histological activity (HAI < 8) were independently associated with SVR. Side effects resulted in PegIFN and ribavirin dose reductions in 9.4% and, respectively, 18.1%, but definitive discontinuation of therapy was necessary only in 8.7% of patients.
  
  
  CONCLUSIONS
  PegIFN alpha-2b and ribavirin can be safe and successful when using a weight-based dosing regimen, leading to high response rates even in overweight patients.
authors.affiliation: Department of Hepatology, Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Str. Fundeni no. 258, 72437 Bucharest, Romania. drgheorghe@xnet.ro
authors.forename: Liana
authors.initials: L
authors.lastname: Gheorghe
authors.forename: Speranta
authors.initials: S
authors.lastname: Iacob
authors.forename: Ioan
authors.initials: I
authors.lastname: Sporea
authors.forename: Mircea
authors.initials: M
authors.lastname: Grigorescu
authors.forename: Roxana
authors.initials: R
authors.lastname: Sirli
authors.forename: Dana
authors.initials: D
authors.lastname: Damian
authors.forename: Cristian
authors.initials: C
authors.lastname: Gheorghe
authors.forename: Razvan
authors.initials: R
authors.lastname: Iacob
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D001835:Body Weight; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011237:Predictive Value of Tests; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b