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

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～TM（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 elastogra-phy（TE）was performed during treatment in a patient subset.RESULTS：Two thousand and sixty patients（n = 253 in Asia）were classif ied as METAVIR F0-1（n = 1682）or F2-4（n = 378）.For F2-4,FS（n = 2055）had sensitiv-ity and specif icity of 0.87 and 0.61,respectively,with area under the receiver-operating curve of 0.82;corre-sponding 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.