Validation of the FibroTest Biochemical Markers Score in Assessing Liver Fibrosis in Hepatitis C Patients

Abstract

Background: Determining the stage of fibrosis by liver biopsy is important in managing patients with hepatitis C virus infection. We investigated the predictive value of the proprietary FibroTest score to accurately identify significant fibrosis in Australian hepatitis C patients. Methods: Serum obtained from 125 confirmed hepatitis C patients before antiviral therapy was analyzed for haptoglobin, α2-macroglobulin, apolipoprotein A1, bilirubin, and γ-glutamyltransferase activity, and the FibroTest score was computed. Liver fibrosis pathology was staged according to a defined system on a scale of F0 to F4. We used predictive values and a ROC curve to assess the accuracy of FibroTest scores. Results: The prevalence of significant fibrosis defined by liver biopsy was 0.38. The most useful single test for predicting significant fibrosis was serum α2-macroglobulin (cutoff value, 2.52 g/L; sensitivity, 75%; specificity, 67%). The negative predictive value of a FibroTest score <0.1 was 85%, and the positive predictive value of a score >0.6 was 78%. Although 33 of the 125 patients had FibroTest scores <0.1 and were therefore deemed unlikely to have fibrosis, 6 (18%) had significant fibrosis. Conversely, of the 24 patients with scores >0.6 who were likely to have significant fibrosis, 5 (21%) had mild fibrosis. Of the 125 patients in the cohort, 57 (46%) could have avoided liver biopsy, but discrepant results were recorded in 11 of those 57 (19%). Conclusion: The FibroTest score could not accurately predict the presence or absence of significant liver fibrosis.

Fib-4

“…[8][9][10][11][12][13][14][15][16][17][18][19][20] These noninvasive tools have a rather good positive predictive value for the diagnosis of moderate or significant fibrosis. [8][9][10][11][12][13][14][15][16][17][18][19][20] They are also simple, inexpensive, and easily reproducible. None of the available biomarkers actually meets these criteria.…”

“…Liver biopsy (LB) is however limited by its invasive nature [1][2][3] ; poor acceptance, especially when repeated measures are required; availability and cost, particularly in non-Western countries; intra-and interobserver variability 4,5 ; and sampling errors, which produce approximately 24% of false negatives for cirrhosis. 6,7 Consequently, noninvasive tests to assess hepatic fibrosis have been developed, such the AST-to-platelet ratio index (APRI), 8 the Forns test, 9 and FibroTest (Biopredictive SAS, Paris, France), [10][11][12][13][14][15][16] which combine several biochemical parameters. More recently, transient elastography (FibroScan, Echosens, Paris, France)-a morphological method that measures liver stiffness-has been evaluated.…”

Diagnosis and Quantitation of Fibrosis

“…The score has been validated in other HCV cohorts, but not all studies achieved the same results. [65][66][67] The paper by Rossi et al 67 found that the FibroTest could not reliably predict the presence or absence of fibrosis in 125 patients with HCV, using local assays and the original authors' computer program to calculate the FibroTest score. However, a recent metaanalysis found that FibroTest is effective in the evaluation of hepatic fibrosis in chronic HCV and chronic hepatitis B virus (HBV), alcoholic liver disease, and nonalcoholic fatty liver disease (NAFLD); and the authors concluded that FibroTest is, in fact, an effective alternative to liver biopsy.…”

A Prospective Analysis of the Prognostic Value of Biomarkers (Fibro Test) in Patients with Chronic Hepatitis C

“…With biopsy as the standard of reference, the diagnostic value of FT for a diagnosis of advanced fibrosis (bridging fibrosis), as estimated by the area under the ROC curve (AUROC), is 0.73-0.86 (8 ). AUROC values inside the range of other studies have been reported, but the usefulness of FT compared with biopsy was not established (17 ). Discordance between FT and biopsy may be related to biopsy failure due mainly to sampling errors and to false-positive and false-negative FT results related to Gilbert syndrome, hemolysis, or acute inflammation (8,18 ).…”