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

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Author(s): 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

Journal: World Journal of Gastroenterology
ISSN 1007-9327

Volume: 17;
Issue: 41;
Start page: 4581;
Date: 2011;
Original page

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

ABSTRACT
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.
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