title: Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.
abstract: BACKGROUND
  Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.
  
  
  METHODS
  1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4.
  
  
  RESULTS
  Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intention-to-treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events.
  
  
  CONCLUSIONS
  FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01508286.
authors.affiliation: Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Antonia
authors.initials: A
authors.lastname: Lepida
authors.affiliation: Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita' degli Studi di Milano, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Colombo
authors.affiliation: Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo, Madrid, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Fernandez
authors.affiliation: I.M. Sechenov First Moscow State Medical University, E.M. Tareev Clinic for Nephrology, Internal and Occupational Medicine, Moscow, Russia.
authors.forename: Djamal
authors.initials: D
authors.lastname: Abdurakhmanov
authors.affiliation: Outpatient Clinic to HIV and Viral Hepatitis Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Paulo Abrao
authors.initials: PA
authors.lastname: Ferreira
authors.affiliation: AW Morrow Gastroenterology and Liver Center, Royal Prince Alfred hospital and University of Sydney, Sydney, Australia.
authors.forename: Simone I
authors.initials: SI
authors.lastname: Strasser
authors.affiliation: Department of Internal Medicine, First Medical Faculty, Charles University, and Central Military Hospital Prague, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Urbanek
authors.affiliation: Liver Unit, IRCCS Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Mangia
authors.affiliation: Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, CIBERehd, Madrid, Spain.
authors.forename: José L
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Janssen Pharmaceuticals, Paris, France.
authors.forename: Wafae
authors.initials: W
authors.lastname: Iraqi
authors.affiliation: Janssen Research and development, Titusville, New Jersey, United States of America.
authors.forename: Ralph
authors.initials: R
authors.lastname: DeMasi
authors.affiliation: Janssen Pharmaceuticals, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Lonjon-Domanec
authors.affiliation: Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Christophe
authors.initials: C
authors.lastname: Moreno
authors.affiliation: Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000209:etiology; D001696:Biomechanical Phenomena / Q000187:drug effects; D005260:Female; D006297:Health Services Accessibility; D016174:Hepacivirus / Q000187:drug effects / Q000502:physiology*; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D006801:Humans; D057194:Intention to Treat Analysis; D008099:Liver / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D008103:Liver Cirrhosis / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009842:Oligopeptides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009842:Oligopeptides; C486464:telaprevir