Validation of liver fibrosis biomarker (FibroTest) for assessing liver fibrosis progression: Proof of concept and first application in a large population

• Published in: Journal of hepatology 2012-09, Vol.57 (3), p.541-548
• Main Authors: Poynard, Thierry, Munteanu, Mona, Deckmyn, Olivier, Ngo, Yen, Drane, Fabienne, Castille, Jean Marie, Housset, Chantal, Ratziu, Vlad, Imbert-Bismut, Françoise
• Format: Article
• Language: English
• Subjects: Adult; Age Factors; alpha-Macroglobulins - metabolism; Apolipoprotein A-I - blood; Bilirubin - blood; Biological and medical sciences; Biomarkers - blood; Biopsy; Disease Progression; Europe, Eastern - ethnology; Fatty Liver, Alcoholic - complications; Female; Fibrosis progression rates; FibroSure; FibroTest; gamma-Glutamyltransferase - blood; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; Haptoglobins - metabolism; Hepatitis B, Chronic - complications; Hepatitis C, Chronic - complications; HIV coinfection; Human viral diseases; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infectious diseases; Liver Cirrhosis - blood; Liver Cirrhosis - etiology; Liver Cirrhosis - pathology; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Middle East - ethnology; Normal transaminases; Other diseases. Semiology; Risk factors of fibrosis; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/j.jhep.2012.04.025

Background & Aims Time-dependent statistics have been used to assess liver fibrosis progression (LFP) in liver diseases from birth to first biopsy, in a limited number of patients. Non-invasive biomarkers such as FibroTest (FT) should allow the estimation of LFP on larger populations. We aimed at validating this concept by comparing LFP using FT vs. biopsy (P1) and then at applying the non-invasive method to a large population (P2). Methods In P1, LFP was assessed using biopsy and FT in 2472 untreated patients: 770 with chronic hepatitis C, 723 with hepatitis B, 761 with non-alcoholic fatty liver disease (NAFLD), and 218 with alcoholic fatty liver disease (ALD). In P2, 342,346 interpretable FT prospectively measured were used. LFP was estimated using transition rates (cumulative hazard rate) to cirrhosis (F4) or to minimal fibrosis (>F0). Results In P1, there was a significant concordance between FT and biopsy estimates of hazards with intraclass correlation (ICC) = 0.961 (95% CI 0.948–0.970) and 0.899 (95% CI 0.135–0.969) for F4 and >F0, respectively. This concordance persisted according to the disease and the gender. The more rapid LFP to F4 (biopsy/FT) was observed for men with ALD (1.44/1.62), and the slower for women with NAFLD (0.09/0.02). In P2, the LFP started to increase for men at the age of 30 years. The cumulative fibrosis progression rate to minimal fibrosis in women crossed the “man curve” around the age of 80 years. The following factors were associated with LFP to F4 (all p