TY - JOUR
T1 - FibroSURE™ and FibroScan® in relation to treatment response in chronic hepatitis C virus
AU - Patel, Keyur
AU - Friedrich-Rust, Mireen
AU - Lurie, Yoav
AU - Grigorescu, Mircea
AU - Stanciu, Carol
AU - Lee, Chuan Mo
AU - Schiff, Eugene R.
AU - Häussinger, Dieter
AU - Manns, Michael P.
AU - Gerken, Guido
AU - Colle, Isabelle
AU - Torbenson, Michael
AU - Pulkstenis, Erik
AU - Mani Subramanian, G.
AU - McHutchison, John G.
AU - Zeuzem, Stefan
PY - 2011
Y1 - 2011
N2 - 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.
AB - 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.
KW - Albinterferon alfa-2b
KW - FibroSURE
KW - FibroScan
KW - Hepatitis C virus
KW - Interferon
KW - Sustained virological response
KW - Transient elastography
UR - http://www.scopus.com/inward/record.url?scp=82155187178&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=82155187178&partnerID=8YFLogxK
U2 - 10.3748/wjg.v17.i41.4581
DO - 10.3748/wjg.v17.i41.4581
M3 - Article
C2 - 22147963
AN - SCOPUS:82155187178
SN - 1007-9327
VL - 17
SP - 4581
EP - 4589
JO - World journal of gastroenterology
JF - World journal of gastroenterology
IS - 41
ER -