title: A Predictive Model for Selecting Patients with HCV Genotype 3 Chronic Infection with a High Probability of Sustained Virological Response to Peginterferon Alfa-2a/Ribavirin.
abstract: BACKGROUND
  Access to direct-acting antiviral agents (DAAs) is restricted in some settings; thus, the European Association for the Study of the Liver recommends dual peginterferon/ribavirin (PegIFN/RBV) therapy wherever DAAs are unavailable. HCV genotype (GT) 3 infection is now the most difficult genotype to eradicate and PegIFN/RBV remains an effective option. The goal of this study was to devise a simple predictive score to identify GT3 patients with a high probability of achieving a sustained virologic response (SVR) with PegIFN alfa-2a/RBV therapy.
  
  
  METHODS
  Relationships between baseline characteristics and SVR were explored by multiple logistic regression models and used to develop a simple scoring system to predict SVR using data from 1239 treatment-naive GT3 patients who received PegIFN alfa-2a/RBV for 24 weeks in two large observational cohort studies.
  
  
  RESULTS
  The score was validated using a database of 473 patients. Scores were assigned for six factors as follows: age (years) (≤40: 2 points; >40 but ≤55: 1); bodyweight (kg) (<70: 2; ≥70 but <90: 1); no cirrhosis/transition to cirrhosis (2); ALT ≤2.5 x ULN (1); platelets (109/L) (>200: 2; ≥100 but <200: 1); HCV RNA (<400,000 IU/mL: 1). The points are summed to arrive at a score ranging from 0‒10 where higher scores indicate higher chances of SVR; 141, 123, 203, 249, 232, and 218 patients had total scores of 0‒4, 5, 6, 7, 8, and 9-10, respectively, among whom SVR rates were 45%, 62%, 72%, 76%, 84%, and 89%. Among 622 patients who had scores of 6‒10 and HCV RNA <50 IU/mL by treatment week 4 the SVR rate was 86% (532/622).
  
  
  CONCLUSIONS
  A simple baseline scoring system involving age, bodyweight, cirrhosis status, ALT level, platelet count and HCV RNA level can be used to identify treatment-naive Caucasian patients with HCV GT3 infection with a high probability of SVR with PegIFN alfa-2a/RBV therapy.
authors.affiliation: Centre de Recherche sur l'Inflammation (CRI), UMR 1149 Inserm, Université Paris Diderot, Service d'Hépatologie, AP-HP Hôpital Beaujon, Paris, France.
authors.forename: Tarik
authors.initials: T
authors.lastname: Asselah
authors.affiliation: Department of Gastroenterology, St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.
authors.forename: Alex J
authors.initials: AJ
authors.lastname: Thompson
authors.affiliation: Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540, Białystok, Poland.
authors.forename: Robert
authors.initials: R
authors.lastname: Flisiak
authors.affiliation: UCM Digestive Diseases and CIBERehd, Valme University Hospital, University of Seville, Seville, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero-Gomez
authors.affiliation: Biostatistics, PROMETRIS GmbH, 68219, Mannheim, Germany.
authors.forename: Diethelm
authors.initials: D
authors.lastname: Messinger
authors.affiliation: Global Product Development Medical Affairs, F. Hoffmann-La Roche Ltd, 4074, Basel, Switzerland.
authors.forename: Georgios
authors.initials: G
authors.lastname: Bakalos
authors.affiliation: Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, Richmond, VA, United States of America.
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008962:Models, Theoretical; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a