title: Defer or treat? Reasons for treatment decisions in patients with chronic hepatitis C genotype 1 in the early era of directly acting antiviral agents.
abstract: BACKGROUND
  In chronic genotype 1 hepatitis C, telaprevir or boceprevir plus peginterferon and ribavirin have become the new standard of care. Aim of this study was to identify factors contributing to the decision whether to defer or treat with the current triple regimens.
  
  
  METHODS
  Prospective assessment of eight parameters on 0-4-point scales by the attending physician at a German tertiary referral centre between 1st September 2011 and 31st December 2012.
  
  
  RESULTS
  307 patients were evaluated at least once by one of the 11 hepatologists involved; 267 patients were considered, but only 163 were recommended to receive triple therapy. Multivariate regression analysis revealed that a higher degree of fibrosis was most strongly associated with a recommendation for treatment (OR 2.69), followed by the patients' demand (OR 2.27), presumed efficacy (OR 1.62), and tolerability (OR 1.58). A high risk of decompensation was associated with the decision to defer (OR 0.39). Speed of progression, compliance, extrahepatic manifestation, gender and age were not significantly related to the recommendation. Treatment was finally started in 101 patients (32.9%).
  
  
  CONCLUSIONS
  In chronic genotype 1 hepatitis C, advanced fibrosis and patients' preference are the main rationales to choose treatment rather than deferral in a real-life setting.
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany. Electronic address: jens.kittner@unimedizin-mainz.de.
authors.forename: Jens M
authors.initials: JM
authors.lastname: Kittner
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Nora M
authors.initials: NM
authors.lastname: Weiss
authors.affiliation: Clinic of Psychosomatic Medicine and Psychotherapy, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Wiltink
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Jörg M
authors.initials: JM
authors.lastname: Schattenberg
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Grambihler
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Thieringer
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Arndt
authors.initials: A
authors.lastname: Weinmann
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Zimmermann
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Koch
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Schuchmann
authors.affiliation: 1st Medical Department, Internal Medicine Department, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Galle
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D003657:Decision Making; D018450:Disease Progression; D004337:Drug Carriers / Q000627:therapeutic use; D055808:Drug Discovery; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009842:Oligopeptides / Q000627:therapeutic use*; D057240:Patient Preference; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011392:Proline / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D057832:Watchful Waiting
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D016898:Interferon-alpha; D009842:Oligopeptides; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline
keywords: Boceprevir; Chronic hepatitis C genotype 1; DAAs; Real-life data; Telaprevir; Therapy decision