title: FibroSURE and FibroScan in relation to treatment response in chronic hepatitis C virus.
abstract: OBJECTIVE
  To compare histological endpoint assessment using noninvasive alternatives to biopsy during treatment in a chronic hepatitis C virus (HCV) cohort.
  
  
  METHODS
  Patients with chronic HCV were randomized to receive interferon-based therapy for 24 (genotypes 2/3) or 48 (genotype 1) wk. FibroSURE™ (FS) was assessed at baseline and at week-12 post-treatment follow-up. Baseline biopsy for METAVIR was assessed by a single pathologist. FibroScan(®) transient elastography (TE) was performed during treatment in a patient subset.
  
  
  RESULTS
  Two thousand and sixty patients (n = 253 in Asia) were classified as METAVIR F0-1 (n = 1682) or F2-4 (n = 378). For F2-4, FS (n = 2055) had sensitivity and specificity of 0.87 and 0.61, respectively, with area under the receiver-operating curve of 0.82; corresponding values for TE (n = 214) and combined FS/TE (n = 209) were 0.77, 0.88 and 0.88, and 0.93, 0.68 and 0.88. Overall FS/TE agreement for F2-4 was 71% (κ = 0.41) and higher in Asians vs non-Asians (κ = 0.86 vs 0.35; P < 0.001). Combined FS/TE had 97% accuracy in Asians (n = 33). Baseline FS (0.38 vs 0.51, P < 0.001) and TE (8.0 kPa vs 11.9 kPa, P = 0.006) scores were lower in patients with sustained virological response than in nonresponders, and were maintained through follow-up.
  
  
  CONCLUSIONS
  FS and TE may reliably differentiate mild from moderate-advanced disease, with a potential for high diagnostic accuracy in Asians with chronic HCV.
authors.affiliation: Department of Gastroenterology and Hepatology, Duke Clinical Research Institute, Durham, NC 27715, United States. keyur.patel@duke.edu
authors.forename: Keyur
authors.initials: K
authors.lastname: Patel
authors.forename: Mireen
authors.initials: M
authors.lastname: Friedrich-Rust
authors.forename: Yoav
authors.initials: Y
authors.lastname: Lurie
authors.forename: Mircea
authors.initials: M
authors.lastname: Grigorescu
authors.forename: Carol
authors.initials: C
authors.lastname: Stanciu
authors.forename: Chuan-Mo
authors.initials: CM
authors.lastname: Lee
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Schiff
authors.forename: Dieter
authors.initials: D
authors.lastname: Häussinger
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
authors.forename: Guido
authors.initials: G
authors.lastname: Gerken
authors.forename: Isabelle
authors.initials: I
authors.lastname: Colle
authors.forename: Michael
authors.initials: M
authors.lastname: Torbenson
authors.forename: Erik
authors.initials: E
authors.lastname: Pulkstenis
authors.forename: G Mani
authors.initials: GM
authors.lastname: Subramanian
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D044466:Asian People; D001706:Biopsy; D015331:Cohort Studies; D054459:Elasticity Imaging Techniques / Q000379:methods*; D005260:Female; D005355:Fibrosis; D016174:Hepacivirus / Q000235:genetics / Q000378:metabolism*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology* / Q000503:physiopathology*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012372:ROC Curve
chemical_list: D000998:Antiviral Agents; D007372:Interferons