Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C

Poynard Thierry, Imbert-Bismut Françoise, Munteanu Mona, Messous Djamila, Myers, Thabut Dominique, Ratziu Vlad, Mercadier Anne, Benhamou Yves, Hainque, Hainque Bernard

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Summary Background Recent studies strongly suggest that due to the limitations and risks of biopsy, as well as the improvement of the diagnostic accuracy of biochemical markers, liver biopsy should no longer be considered mandatory in patients with chronic hepatitis C. In 2001, FibroTest ActiTest (FT-AT), a panel of biochemical markers, was found to have high diagnostic value for fibrosis (FT range 0.00–1.00) and necroinflammatory histological activity (AT range 0.00–1.00). The aim was to summarize the diagnostic value of these tests from the scientific literature; to respond to frequently asked questions by performing original new analyses (including the range of diagnostic values, a comparison with other markers, the impact of genotype and viral load, and the diagnostic value in intermediate levels of injury); and to develop a system of conversion between the biochemical and biopsy estimates of liver injury. Results A total of 16 publications were identified. An integrated database was constructed using 1,570 individual data, to which applied analytical recommendations. The control group consisted of 300 prospectively studied blood donors. For the diagnosis of significant fibrosis by the METAVIR scoring system, the areas under the receiver operating characteristics curves (AUROC) ranged from 0.73 to 0.87. For the diagnosis of significant histological activity, the AUROCs ranged from 0.75 to 0.86. At a cut off of 0.31, the FT negative predictive value for excluding significant fibrosis (prevalence 0.31) was 91%. At a cut off of 0.36, the ActiTest negative predictive value for excluding significant necrosis (prevalence 0.41) was 85%. In three studies there was a direct comparison in the same patients of FT versus other biochemical markers, including hyaluronic acid, the Forns index, and the APRI index. All the comparisons favored FT (P < 0.05). There were no differences between the AUROCs of FT-AT according to genotype or viral load. The AUROCs of FT-AT for consecutive stages of fibrosis and grades of necrosis were the same for both moderate and extreme stages and grades. A conversion table was constructed between the continuous FT-AT values (0.00 to 1.00) and the expected semi-quantitative fibrosis stages (F0 to F4) and necrosis grades (A0 to A3). Conclusions Based on these results, the use of the biochemical markers of liver fibrosis (FibroTest) and necrosis (ActiTest) can be recommended as an alternative to liver biopsy for the assessment of liver injury in patients with chronic hepatitis C. In clinical practice, liver biopsy should be recommended only as a second line test, i.e. , in case of high risk of error of biochemical tests.

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• Publié par: biomed
• Publié le: 01 janvier 2004
• Nombre de lectures: 15
• Langue: English

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Comparative Hepatology

Bio Med  Central

Research Open Access Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSur e) and necrosis (ActiTest) in patients with chronic hepatitis C Thierry Poynard*, Françoise Imbert-Bismut, Mona Munteanu, Djamila Messous, Robert P Myers, Dominique Thabut, Vlad Ratziu, Anne Mercadier, Yves Benhamou and Bernard Hainque

Address: Groupe Hospital ier Pitié-Salpêtrière, 47-83 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France Email: Thierry Poynard* - [e-mail]; Françoise Imbert-Bismut - [e-mail]; Mona Munteanu - mona.munteanu@biopredictive .com; Djamila Messous - [e-mail] m; Robert P Myers - [e-mail]; Dominique Thabut - [e-mail]; Vlad Ratziu - vratziu@t easer.fr; Anne Mercadier - anne.m [e-mail]; Yves Benhamou - [e-mail]; Bernard H ainque - [e-mail] * Corresponding author

Published: 23 September 2004 Received: 26 March 2004 Comparative Hepatology 2004, 3 :8 doi:10.1186/1476-5926-3-8  Accepted: 23 September 2004 This article is available from: http:// www.comparative-hepatology.com/content/3/1/8 © 2004 Poynard et al; licensee BioMed Central Ltd. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons. org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the orig inal work is properly cited.

Summary Background: Recent studies strongly suggest that due to the limitation s and risks of biopsy, as well as the improvement of the diagnostic accuracy of biochemical markers, liver biopsy should no longer be co nsidered mandatory in patients with chronic hepatitis C. In 2001, FibroTest ActiTest (F T-AT), a panel of biochemical markers, wa s found to have high diagnostic value for fibrosis (FT range 0.00–1.00) and necroinf lammatory histological activity (AT range 0.00–1.00). The aim was to summarize the diagnostic value of these tests from the scie ntific literature; to respond to frequent ly asked questions by performing original new analyses (including the ra nge of diagnostic values, a compar ison with other markers, the impa ct of genotype and viral load, and the diagnostic value in intermediate levels of injury); and to develop a system of co nversion between the biochemical and biops y estimates of liver injury. Results: A total of 16 publications were identified. An integrated da tabase was constructed using 1, 570 individual data, to which applied analytical recommend ations. The control group consiste d of 300 prospectively studied blood donors. For the diagnosis of significant fibrosis by the METAVIR sc oring system, the areas under the receiver operating characteristics curves (AUROC) ranged from 0.73 to 0.87. For the diagnosis of significant histological activity, the AU ROCs ranged from 0.75 to 0.86. At a cut off of 0.31, the FT negative pr edictive value for excluding sign ificant fibrosis (prevalence 0.31) was 91%. At a cut off of 0.3 6, the ActiTest negative predictive value for excl uding significant necrosis (prevalence 0. 41) was 85%. In three studies there was a direct comparison in the same patients of FT versus other biochemical markers, including hy aluronic acid, the Forns index, and the APRI index. All the comparisons favo red FT (P < 0.05). There were no differences between the AUROCs of FT-AT according to genotype or viral load. The AURO Cs of FT-AT for consecutive stages of fi brosis and grades of necrosis were the same for both moderate and extreme stag es and grades. A conversion table was co nstructed between the continuous FT-AT values (0.00 to 1.00) and the expected semi-quantitative fibrosis stages (F 0 to F4) and necrosis grades (A0 to A3). Conclusions: Based on these results, the use of th e biochemical markers of liver fibrosis (FibroTest) and necrosis (ActiTest) can be recommended as an alternative to li ver biopsy for the assessment of liver inju ry in patients with chronic hepatitis C. I n clinical practice, liver biopsy should be recommended only as a second line test, i.e. , in case of high risk of error of biochemical tests.

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