World J Gastroenterol. 2011 Nov 7;17(41):4581-9. doi: 10.3748/wjg.v17.i41.4581.

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

Patel K, Friedrich-Rust M, Lurie Y, Grigorescu M, Stanciu C, Lee CM, Schiff ER, Häussinger D, Manns MP, Gerken G, Colle I, Torbenson M, Pulkstenis E, Subramanian GM, McHutchison JG, Zeuzem S.

Source

Department of Gastroenterology and Hepatology, Duke Clinical Research Institute, Durham, NC 27715, United States. keyur.patel@duke.edu

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.