title: A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin.
abstract: OBJECTIVE
  Pretreatment identification of patients likely to achieve a sustained virological response (SVR) with peginterferon alfa-2a/ribavirin would be useful for individualizing treatment choices. The aim of this analysis was to devise a simple scoring system to identify patients with high probability of achieving an SVR with peginterferon alfa-2a/ribavirin.
  
  
  METHODS
  Using data from 2109 Caucasian treatment-naive hepatitis C virus (HCV) genotype 1 mono-infected patients from the PROPHESYS cohorts, the relationship between favourable baseline characteristics and SVR was explored using generalized additive model analysis, and a scoring system was devised to predict SVR.
  
  
  RESULTS
  Points were assigned for: age (years) (≤35: 2; >35, ≤45: 1; >45: 0); body mass index (kg/m(2)) (≤20: 2; >20, ≤22: 1; >22: 0); HCV RNA (IU/ml) (≤100,000: 3; >100,000-400,000: 2; >400,000-800,000: 1; >800,000: 0); platelets (>150 ×10(9)/l: 1; ≤150 ×10(9)/l: 0); alanine aminotransferase [×upper limit of normal (ULN)] (>3: 1; ≤3: 0); serum aspartate aminotransferase (×ULN) (≤1: 1; >1: 0). 1029, 698 and 382 patients had scores of 0-2, 3-4 and ≥5, respectively, among whom SVR rates were 35.0, 54.9 and 76.7%. SVR in patients with scores ≥5 and undetectable HCV RNA by week 4 was 86.7%. The score was tested against two databases of patients who received peginterferon alfa-2a/ribavirin in other clinical trials; similar high SVR rates in patients with scores ≥5 were reported.
  
  
  CONCLUSIONS
  The scoring system can reliably identify treatment-naive HCV genotype 1 mono-infected Caucasian patients who have a high probability of achieving an SVR with peginterferon alfa-2a/ribavirin and will be particularly useful where protease inhibitors are not readily available.
authors: Medical University of Vienna, Vienna, Austria.
authors: Peter
authors: P
authors: Ferenci
authors: Rodrigo
authors: R
authors: Aires
authors: Ioan
authors: I
authors: Ancuta
authors: Andrew
authors: A
authors: Arohnson
authors: Hugo
authors: H
authors: Cheinquer
authors: Dragan
authors: D
authors: Delic
authors: Michael
authors: M
authors: Gschwantler
authors: Dominique
authors: D
authors: Larrey
authors: Ludovico
authors: L
authors: Tallarico
authors: Manuela
authors: M
authors: Schmitz
authors: Fernando
authors: F
authors: Tatsch
authors: Denis
authors: D
authors: Ouzan
mesh_terms: D000328:Adult; D000367:Age Factors; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D015992:Body Mass Index; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010976:Platelet Count; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design; D012254:Ribavirin / Q000627:therapeutic use*; D044465:White People
chemical_list: D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a
keywords: Caucasian; PROPHESYS; hepatitis C; peginterferon alfa/ribavirin; predictive scoring; sustained virological response