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

• Published in: World journal of gastroenterology : WJG 2011-11, Vol.17 (41), p.4581-4589
• Main Authors: Patel, Keyur, Friedrich-Rust, Mireen, Lurie, Yoav, Grigorescu, Mircea, Stanciu, Carol, Lee, Chuan-Mo, Schiff, Eugene R, Häussinger, Dieter, Manns, Michael P, Gerken, Guido, Colle, Isabelle, Torbenson, Michael, Pulkstenis, Erik, Subramanian, G Mani, McHutchison, John G, Zeuzem, Stefan
• Format: Article
• Language: English
• Subjects: Adult; Antiviral Agents - therapeutic use; Asian People; Biopsy; Brief; Cohort Studies; Elasticity Imaging Techniques - methods; Female; Fibrosis; Hepacivirus - genetics; Hepacivirus - metabolism; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - genetics; Hepatitis C, Chronic - pathology; Hepatitis C, Chronic - physiopathology; Humans; Interferons - therapeutic use; Liver - pathology; Male; Middle Aged; Prospective Studies; ROC Curve
• ISSN: 1007-9327; 2219-2840
• DOI: 10.3748/wjg.v17.i41.4581

To compare histological endpoint assessment using noninvasive alternatives to biopsy during treatment in a chronic hepatitis C virus (HCV) cohort. 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. 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. FS and TE may reliably differentiate mild from moderate-advanced disease, with a potential for high diagnostic accuracy in Asians with chronic HCV.