November 28, 2013

Journal of Hepatology

Article in Press

Thierry Poynard, Julien Vergniol, Yen Ngo, Juliette Foucher, Mona Munteanu, Wassil Merrouche, Massimo Colombo, Vincent Thibault, Eugene Schiff, Clifford A. Brass, Janice K. Albrecht Marika Rudler,Olivier Deckmyn, Pascal Lebray, Dominique Thabut, Vlad Ratziu,Victor de Ledinghen, on behalf of FibroFrance Study Group, the Epic3 Study Group and the Bordeaux HCV Study Group.

Received 8 October 2013; received in revised form 15 November 2013; accepted 19 November 2013. published online 27 November 2013.
Accepted Manuscript

Abstract

Background and Aims

FibroTest (FT) and Transient Elastography (TE) have been validated as noninvasive markers of METAVIR fibrosis stages from F0 to F4 using biopsy, and as prognostic markers of liver related mortality in patients with chronic hepatitis C. The aim was to extend the validation of FT and TE as markers of critical steps defined by occurrence of cirrhosis without complications (F4.1), esophageal varices (F4.2), and severe complications (F4.3): primary liver cancer, variceal bleeding, or decompensation (ascites, encephalopathy, or jaundice).

Methods

The updated individual data of 3927 patients (1046 cirrhotics) without complications at baseline were pooled from three prospective cohorts called “EPIC”, “Paris” and “Bordeaux” cohorts.

Results

At 5 years among 501 patients without varices at baseline (F4.1), varices occurred in 19 patients F4.2 incidence of 4.0% (95%CI 2.2-5.8). The predictive performance (AUROC) of FT was 0.77 (0.66-0.84; P<0.001).

At 10 years severe complications occurred in 203 patients, F4.3 incidence of 13.4% (9.6-17.1), including primary liver cancer in 84 patients 6.4%(3.5-9.3). FT was predictive (Cox adjusted on treatment) of severe complications AUROC 0.79(76-82); P<0.0001, including primary liver cancer AUROC 0.84(80-87); P<0.0001. Similarly TE was predictive of severe complications AUROC 0.77(72-81); P<0.0001, including primary liver cancer AUROC 0.86(81-90); P<0.0001.

Conclusion

FibroTest and TE increase were associated with the occurrence of all severe complications including hepatocellular carcinoma, hepatic insufficiency and variceal bleeding. FibroTest increase was also associated with the occurrence of esophageal varices.

Keywords: FibroTest, Elastography, Fibrosis stages, Cirrhosis complications, Prognostic factors, Hepatocellular carcinoma, Surrogate markers

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