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Clinical Chemistry 52: 1887-1896, 2006. First published August 24, 2006; 10.1373/clinchem.2006.070961
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(Clinical Chemistry. 2006;52:1887-1896.)
© 2006 American Association for Clinical Chemistry, Inc.

Proteomics and Protein Markers

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

Yen Ngo1, Mona Munteanu2, Djamila Messous3, Frederic Charlotte4, Françoise Imbert-Bismut3, Dominique Thabut1, Pascal Lebray1, Vincent Thibault5, Yves Benhamou1, Joseph Moussalli1, Vlad Ratziu1 and Thierry Poynard1,a

1 Service d’Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, CNRS, Paris, France.
2 Biopredictive, Paris, France.
3 Laboratoire de Biochimie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
4 Service d’Anatomie Pathologique Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
5 Laboratoire de Virologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.

aAddress correspondence to this author at: Service d’Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, 47 Boulevard de l’Hôpital 75651 Paris Cedex 13, France. Fax (33-1)-42-16-14-27; e-mail tpoynard{at}teaser.fr.

Background: FibroTest, a noninvasive method of measuring biomarkers of liver fibrosis, is an alternative to liver biopsy for determining the severity of chronic hepatitis C virus (HCV) infection. We compared the 5-year prognostic value of the FibroTest with biopsy staging for predicting cirrhosis decompensation and survival in patients with chronic HCV infection.

Methods: Fibrosis stage was assessed on the same day by FibroTest and biopsy in a prospective cohort of 537 patients. Disease classification at baseline was 157 patients with severe fibrosis (FibroTest >0.58), 137 with moderate fibrosis (FibroTest 0.32–0.58), and 243 with no or minimal fibrosis (FibroTest <0.32).

Results: In 64 untreated patients with severe fibrosis, survival without HCV complications was 73% [95% confidence interval (CI), 59%–086%; 13 complications], and survival without HCV-related death was 85% (95% CI, 73%–96%; 7 HCV deaths). Survival rates were higher in patients with moderate fibrosis, [99% (95% CI, 97%–100%; 1 complication; P <0.001) and 100% (no HCV death; P <0.001) for patients with and without HCV-related complications, respectively], and in patients with minimal fibrosis [100% (no complication; P <0.001 vs severe) and 100% (no HCV death; P <0.001 vs severe), respectively]. FibroTest was a better predictor than biopsy staging for HCV complications, with area under the ROC curves (AUROC) = 0.96 (95% CI, 0.93%–0.97%) vs 0.91 (95% CI, 0.85%–0.94%; P = 0.01), respectively; it was also a better predictor for HCV deaths: AUROC = 0.96 (95% CI, 0.93%–0.98%) vs 0.87 (95% CI, 0.70%–0.94%; P = 0.046), respectively. The prognostic value of FibroTest was still significant (P <0.001) in multivariate analyses after taking into account histology, treatment, alcohol consumption, and HIV coinfection.

Conclusion: The FibroTest measurement of HCV biomarkers has a 5-year prognostic value similar to that of liver biopsy.




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