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 therapyfor 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.
RCT Entities:
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.
Authors: C Nøjgaard; J S Johansen; H B Krarup; M Holten-Andersen; A Møller; F Bendtsen Journal: Scand J Gastroenterol Date: 2003-06 Impact factor: 2.423
Authors: Stefan Zeuzem; Mark S Sulkowski; Eric J Lawitz; Vinod K Rustgi; Maribel Rodriguez-Torres; Bruce R Bacon; Mircea Grigorescu; Alan D Tice; Yoav Lurie; Janusz Cianciara; Andrew J Muir; Patrick W Cronin; Erik Pulkstenis; G Mani Subramanian; John G McHutchison Journal: Gastroenterology Date: 2010-06-27 Impact factor: 22.682
Authors: K Patel; Y Benhamou; E M Yoshida; K D Kaita; S Zeuzem; M Torbenson; E Pulkstenis; G M Subramanian; J G McHutchison Journal: J Viral Hepat Date: 2008-10-24 Impact factor: 3.728
Authors: J Vergniol; J Foucher; L Castéra; P-H Bernard; R Tournan; E Terrebonne; E Chanteloup; W Merrouche; P Couzigou; V de Lédinghen Journal: J Viral Hepat Date: 2008-10-17 Impact factor: 3.728
Authors: Michael W Fried; Victor J Navarro; Nezam Afdhal; Steven H Belle; Abdus S Wahed; Roy L Hawke; Edward Doo; Catherine M Meyers; K Rajender Reddy Journal: JAMA Date: 2012-07-18 Impact factor: 56.272