title: Non-invasive fibrosis assessment predicts sustained virological response to telaprevir with pegylated interferon and ribavirin for chronic hepatitis C.
abstract: BACKGROUND
  Liver fibrosis remains one of the most important predictors of sustained virological response (SVR) in this era of direct-acting antiviral treatment of chronic hepatitis C. We compare non-invasive fibrosis assessment with liver biopsy (METAVIR) in terms of their ability to predict SVR by telaprevir (TVR)-based triple therapy.
  
  
  METHODS
  This prospective study consisted of 108 patients with chronic HCV genotype 1 infection who received TVR in combination with pegylated interferon (PEG-IFN)-α2b and ribavirin (RBV). Non-invasive fibrosis data included transient elastography (FibroScan), FIB-4 index and aspartate aminotransferase to platelet ratio index (APRI).
  
  
  RESULTS
  SVR was achieved by 84.3% of the patients by intention-to-treat analysis. In contrast to the high SVR rates for treatment-naive patients (87.1%, 27 of 31) and patients who previously relapsed (97.9%, 46 of 47), the SVR rate of prior partial/null responders was significantly lower (60.0%, 18 of 30). The impact of fibrosis on SVR was greater for prior partial/null responders, and fibrosis data, including both METAVIR score and non-invasive fibrosis assessments, were useful for predicting SVR. The METAVIR score (area under the receiver operating characteristic curve [AUROC] 0.91, cutoff ≤F2), FibroScan values (AUROC 0.99, cutoff ≤10.0 kPa), FIB-4 index (AUROC 0.91, cutoff ≤3.5) and APRI (AUROC 0.91, cutoff ≤0.80) were shown to have equal, excellent predictive power.
  
  
  CONCLUSIONS
  An alternative to METAVIR score by liver biopsy, non-invasive fibrosis assessments are useful options for predicting SVR by prior partial or null responders in TVR-based triple therapy.
authors.affiliation: Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan. eogawa@gim.med.kyushu-u.ac.jp.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Ogawa
authors.forename: Norihiro
authors.initials: N
authors.lastname: Furusyo
authors.forename: Motohiro
authors.initials: M
authors.lastname: Shimizu
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ihara
authors.forename: Takeo
authors.initials: T
authors.lastname: Hayashi
authors.forename: Yuji
authors.initials: Y
authors.lastname: Harada
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Toyoda
authors.forename: Masayuki
authors.initials: M
authors.lastname: Murata
authors.forename: Jun
authors.initials: J
authors.lastname: Hayashi
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D019540:Area Under Curve; D001219:Aspartate Aminotransferases / Q000097:blood; D015415:Biomarkers / Q000032:analysis; D001706:Biopsy; D004359:Drug Therapy, Combination; D054459:Elasticity Imaging Techniques; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000502:physiology; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008099:Liver / Q000187:drug effects / Q000473:pathology / Q000821:virology; D008103:Liver Cirrhosis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use; D010976:Platelet Count; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D012372:ROC Curve; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects*
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; D001219:Aspartate Aminotransferases; C100416:peginterferon alfa-2a