FibroSURE™ and FibroScan® in relation to treatment response in chronic hepatitis C virus

Keyur Patel, Mireen Friedrich-Rust, Yoav Lurie, Mircea Grigorescu, Carol Stanciu, Chuan Mo Lee, Eugene R. Schiff, Dieter Häussinger, Michael P. Manns, Guido Gerken, Isabelle Colle, Michael Torbenson, Erik Pulkstenis, G. Mani Subramanian, John G. McHutchison, Stefan Zeuzem

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


AIM: 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. CONCLUSION: FS and TE may reliably differentiate mild from moderate-advanced disease, with a potential for high diagnostic accuracy in Asians with chronic HCV.

Original languageEnglish (US)
Pages (from-to)4581-4589
Number of pages9
JournalWorld journal of gastroenterology
Issue number41
StatePublished - 2011


  • Albinterferon alfa-2b
  • FibroSURE
  • FibroScan
  • Hepatitis C virus
  • Interferon
  • Sustained virological response
  • Transient elastography

ASJC Scopus subject areas

  • Gastroenterology


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