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Dual cut-off transient elastography to assess liver fibrosis in chronic hepatitis B: a cohort study with internal validation

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http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2011.04722.x/abstract;jse\

ssionid=42BC807ED48D641F8E239A805D89021B.d01t04

Dual cut-off transient elastography to assess liver fibrosis in chronic

hepatitis B: a cohort study with internal validation

M. Viganò1,2, S. Paggi3, P. Lampertico1, M. Fraquelli3, S. Massironi3, G.

Ronchi1, C. Rigamonti1, D. Conte3, M. Colombo1

Article first published online: 1 JUN 2011

DOI: 10.1111/j.1365-2036.2011.04722.x

© 2011 Blackwell Publishing Ltd

Issue

Alimentary Pharmacology & Therapeutics

Early View (Online Version of Record published before inclusion in an issue)

Summary

Background Transient elastography has gained popularity to stage liver fibrosis

in chronic viral hepatitis, however, diagnostic cut-offs for severe fibrosis in

chronic hepatitis B are poorly defined.

Aim To evaluate an algorithm with two distinct cut-offs for positive and

negative prediction of significant fibrosis and cirrhosis in chronic hepatitis B

patients.

Methods Two cohorts of treatment-naïve patients with chronic hepatitis B (125

training and 92 validations) were consecutively and concurrently examined by

percutaneous liver biopsy and transient elastography. Fibrosis was staged by

Metavir (significant fibrosis = F ≥ 2; cirrhosis = F4) in ≥2 cm long liver

tissue cores.

Results A >13.1 kPa positive and a ≤9.4 kPa negative cut-off for cirrhosis

had a >90% sensitivity and specificity, with an accuracy of 94%. The

corresponding cut-offs for F ≥ 2 were >9.4 and ≤6.2 kPa, thus classifying

56% of patients with an overall accuracy of 90%. In the validation cohort, F4

and F ≥ 2 were predicted by the above transient elastography cut-offs with an

overall accuracy >90%. In 165 patients with higher than upper limit of normal

transaminase activity the dual cut-off algorithm of transient elastography was

as accurate as in the 52 patients with normal alanine aminotransferase values in

the prediction and exclusion of cirrhosis, only.

Conclusions A dual cut-off algorithm allowed for correctly classifying both

significant fibrosis and cirrhosis in the majority of the patients with chronic

hepatitis B, independent of alanine aminotransferase values, thus reducing the

need for liver biopsy investigations.

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