March 15, 2014

Prospective evaluation of Fibrotest®, Fibrometer® and Hepascore® for staging liver fibrosis in chronic hepatitis B: Comparison with hepatitis C

Journal of Hepatology

Article in Press

Vincent Leroy, Nathalie Sturm, Patrice Faure, Candice Trocme,  Alice Marl, Marie-Noëlle Hilleret, Françoise MorelJean-Pierre Zarski

Received 8 November 2013; received in revised form 24 January 2014; accepted 22 February 2014. published online 12 March 2014.
Accepted Manuscript

Abstract

Background & aims

Fibrosis blood tests have been validated in chronic hepatitis C. Their diagnostic accuracy is less documented in hepatitis B. The aim of this study was to describe the diagnostic performance of Fibrotest®, Fibrometer® and Hepascore® for liver fibrosis in hepatitis B compared to hepatitis C.

Methods

510 patients mono-infected with hepatitis B or C and matched on fibrosis stage were included. Blood tests were performed the day of the liver biopsy. Histological lesions were staged according to METAVIR.

Results

Fibrosis stages were distributed as followed: F0 n=76, F1 n=192, F2 n=132, F3 n=54, F4 n=56. Overall diagnostic performance of blood tests were similar between hepatitis B and C with AUROC ranging from 0.75 to 0.84 for significant fibrosis, 0.82 to 0.85 for extensive fibrosis and 0.84 to 0.87 for cirrhosis. Optimal cut-offs were consistently lower in hepatitis B compared to hepatitis C, especially for the diagnosis of extensive fibrosis and cirrhosis, with decreased sensitivity and negative predictive values. More hepatitis B than C patients with F greater than or equal to 3 were underestimated: Fibrotest®: 47% versus 26%, Fibrometer®: 24% versus 6%, Hepascore®: 41% versus 24%, p<0.01. Multivariate analysis showed that hepatitis B (0R 3.4, CI95% 1.2-19.2, p<0.02) and low γGT (OR 7.3, CI95% 2.0-27.0, p<0.003) were associated with fibrosis underestimation.

Conclusion

Overall the diagnostic performance of blood tests is similar in hepatitis B and C. The risk of underestimating significant fibrosis and cirrhosis is however greater in hepatitis B and cannot be entirely corrected by the use of more stringent cut-offs.

Abbreviations: CHC, chronic hepatitis C, CHB, chronic hepatitis B, TE, Transient elastography, FT, Fibrotest, AUROC, Area under the receiver operator characteristic, FM, Fibrometer, HS, Hepascore, HBV, Hepatitis B virus, HCV, Hepatitis C virus, PPV, Positive predictive value, NPV, Negative predictive value

Keywords: Blood tests, Fibrosis, Cirrhosis, Non-invasive diagnosis, Diagnostic performance

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