Brief Article
Copyright ©2011 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Nov 7, 2011; 17(41): 4581-4589
Published online Nov 7, 2011. doi: 10.3748/wjg.v17.i41.4581
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
Keyur Patel, John G McHutchison, Department of Gastroenterology and Hepatology, Duke Clinical Research Institute, Durham, NC 27715, United States
Mireen Friedrich-Rust, Stefan Zeuzem, Department of Gastroenterology and Hepatology, J.W. Goethe University Hospital, Frankfurt 60590, Germany
Yoav Lurie, Department of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv 64239, Israel
Mircea Grigorescu, Department of Clinical Infectious Disease, Spitalul Clinic de Urgenta, Cluj-Napoca 400162, Romania
Carol Stanciu, Department of Gastroenterology and Hepatology, Institutul de Gastroenterologie si Hepatologie, Iasi 700111, Romania
Chuan-Mo Lee, Department of Gastroenterology, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, 833 Taiwan, China
Eugene R Schiff, Departments of Gastroenterology and Internal Medicine, University of Miami, FL 33136, United States
Dieter Häussinger, Department of Gastroenterology and Hepatology, Universitätsklinik Düsseldorf 40255, Germany
Michael P Manns, Department of Gastroenterology and Hepatology, Medizinische Hochschule Hannover 30623, Germany
Guido Gerken, Department of Gastroenterology and Hepatology, Universitätsklinikum Essen 45122, Germany
Isabelle Colle, Department of Gastroenterology and Hepatology, Ghent University Hospital, Ghent 9000, Belgium
Michael Torbenson, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD 21231, United States
Erik Pulkstenis, Department of Biostatistics, Human Genome Sciences, Inc., Rockville, MD 20850, United States
G Mani Subramanian, Department of Clinical Research, Human Genome Sciences, Inc., Rockville, MD 20850, United States
Author contributions: Patel K was the primary author of the manuscript. Other authors contributed to the manuscript and the study (including manuscript review). Lurie Y, Grigorescu M, Stanciu C, Lee CM, Schiff ER, Häussinger D, Manns MP, Gerken G and Colle I enrolled patients in the study; Friedrich-Rust M, Pulkstenis E, Subramanian GM, McHutchison JG and Zeuzem S were responsible for study design, conduct and analysis.
Supported by Human Genome Sciences and Novartis Pharma AG, Basel, Switzerland
Correspondence to: Dr. Keyur Patel, Department of Gastroenterology and Hepatology, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, United States. keyur.patel@duke.edu
Telephone: +1-919-6687193 Fax:+1-919-6687186
Received: December 31, 2010
Revised: March 24, 2011
Accepted: March 31, 2011
Published online: November 7, 2011
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.

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