Comparison of nine blood tests and transient elastography for liver fibrosis in chronic hepatitis C: The ANRS HCEP-23 study

Background & Aims: Blood tests and transient elastography (Fibroscan T) have been developed as alternatives to liver biopsy. This ANRS HCEP-23 study compared the diagnostic accuracy of nine blood tests and transient elastography (Fibroscan T) to assess liver fibrosis, vs. liver biopsy, in untreated patients with chronic hepatitis C (CHC). Methods: This was a multicentre prospective independent study in 19 French University hospitals of consecutive adult patients having simultaneous liver biopsy, biochemical blood tests (performed in a centralized laboratory) and Fibroscan (TM). Two experienced pathologists independently reviewed the liver biopsies (mean length = 25 +/- 8.4 mm). Performance was assessed using ROC curves corrected by Obuchowski's method. Results: Fibroscan (TM) was not interpretable in 113 (22%) patients. In the 382 patients having both blood tests and interpretable Fibroscan (TM), Fibroscan (TM) performed similarly to the best blood tests for the diagnosis of significant fibrosis and cirrhosis. Obuchowski's measure showed Fibrometer (R) (0.86), Fibrotest (R) (0.84), Hepascore (R) (0.84), and interpretable Fibroscan (TM) (0.84) to be the most accurate tests. The combination of Fibrotest (R), Fibrometer (R), or Hepascore (R) with Fibroscan (TM) or Apri increases the percentage of well classified patients from 70-73% to 8083% for significant fibrosis, but for cirrhosis a combination offers no improvement. For the 436 patients having all the blood tests, AUROC's ranged from 0.82 (Fibrometer (R)) to 0.75 (Hyaluronate) for significant fibrosis, and from 0.89 (Fibrometer (R) and Hepascore (R)) to 0.83 (FIB-4) for cirrhosis. Conclusions: Contrarily to blood tests, performance of Fibroscan T was reduced due to uninterpretable results. Fibrotest (R), interpretable Fibroscan (TM), Fibrometer (R), and Hepascore (R) perform best and similarly for diagnosis of significant fibrosis and cirrhosis. (C) 2011 European Association for the Study of the Liver. Published by Elsevier B. V. All rights reserved.