Contribution of the ELFG Test in Algorithms of Non-Invasive Markers towards the Diagnosis of Significant Fibrosis in Chronic Hepatitis C

Abstract

Background and AimsWe aimed to determine the best algorithms for the diagnosis of significant fibrosis in chronic hepatitis C (CHC) patients using all available parameters and tests.Patients and MethodsWe used the database from our study of 507 patients with histologically proven CHC in which fibrosis was evaluated by liver biopsy (Metavir) and tests: Fibrometer®, Fibrotest®, Hepascore®, Apri, ELFG, MP3, Forn's, hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP1), MMP1, collagen IV and when possible Fibroscan™. For the first test we used 90% negative predictive value to exclude patients with F≤1, next an induction algorithm was applied giving the best tests with at least 80% positive predictive value for the diagnosis of F≥2. The algorithms were computed using the R Software C4.5 program to select the best tests and cut-offs. The algorithm was automatically induced without premises on the part of the investigators. We also examined the inter-observer variations after independent review of liver biopsies by two pathologists. A medico-economic analysis compared the screening strategies with liver biopsy.ResultsIn “intention to diagnose” the best algorithms for F≥2 were Fibrometer ®, Fibrotest®, or Hepascore® in first intention with the ELFG score in second intention for indeterminate cases. The percentage of avoided biopsies varied between 50% (Fibrotest® or Fibrometer®+ELFG) and 51% (Hepascore®+ELFG). In “per-analysis” Fibroscan™+ELFG avoided liver biopsy in 55% of cases. The diagnostic performance of these screening strategies was statistically superior to the usual combinations (Fibrometer® or Fibrotest®+Fibroscan™) and was cost effective. We note that the consensual review of liver biopsies between the two pathologists was mainly in favor of F1 (64–69%).ConclusionThe ELFG test could replace Fibroscan in most currently used algorithms for the diagnosis of significant fibrosis including for those patients for whom Fibroscan™ is unusable.

Diagnostic usefulness of FibroMeter VCTE for hepatic fibrosis in patients with nonalcoholic fatty liver disease

“…The FibroMeter VCTE score was determined in all participants using a proprietary algorithm (regression score) by Echosens S.A. (Paris, France) [19]. The NFSA score was calculated on the basis of age, hyperglycemia, BMI, platelets, albumin, and serum aminotransferase levels as described previously [13].…”

“…TE is based on liver stiffness measurements, and its diagnostic usefulness has been confirmed in different clinical cohorts, including patients with NAFLD, chronic viral hepatitis, overweight, and the general population without evidence of overt liver diseases [17,18]. More recently, the FibroMeter VCTE score has been proposed as a viral hepatitis-specific noninvasive method for the assessment of fibrosis [19]. It consists of a proprietary panel combining the results of TE with those of a biochemical panel (platelet count, α2-macroglobulin, urea, prothrombin index, aspartate aminotransferase, alanine aminotransferase, and γ-glutamyl transferase) [19].…”

“…More recently, the FibroMeter VCTE score has been proposed as a viral hepatitis-specific noninvasive method for the assessment of fibrosis [19]. It consists of a proprietary panel combining the results of TE with those of a biochemical panel (platelet count, α2-macroglobulin, urea, prothrombin index, aspartate aminotransferase, alanine aminotransferase, and γ-glutamyl transferase) [19]. Although this test has been designed specifically for viral hepatitis [19], we hypothesized that it could also be diagnostically useful for patients with NAFLD.…”

“…It consists of a proprietary panel combining the results of TE with those of a biochemical panel (platelet count, α2-macroglobulin, urea, prothrombin index, aspartate aminotransferase, alanine aminotransferase, and γ-glutamyl transferase) [19]. Although this test has been designed specifically for viral hepatitis [19], we hypothesized that it could also be diagnostically useful for patients with NAFLD. Accordingly, all of the imaging and biochemical components of the FibroMeter VCTE score have been associated with fibrosis not only in viral hepatitis but also in NAFLD [19].…”

“…Although this test has been designed specifically for viral hepatitis [19], we hypothesized that it could also be diagnostically useful for patients with NAFLD. Accordingly, all of the imaging and biochemical components of the FibroMeter VCTE score have been associated with fibrosis not only in viral hepatitis but also in NAFLD [19]. We therefore designed the current pilot study to investigate the diagnostic performance of FibroMeter VCTE for determination of fibrosis in patients with biopsy-proven NAFLD.…”