Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C

The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance.

In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.

Inclusion Criteria:

• patient with an Ac-HCV positive and RNA HCV positive or AgHBs-positive,
• naive to treatment or not receiving treatment for viral eradication in six months,
• patient for whom a liver biopsy size less than 15 mm, regardless of the number of portal tracts present or fragments, is being considered or has been performed between two and one month before inclusion,
• Patient affiliated to social security or similar regime,
• patients who signed consent for participation in the study.

Exclusion Criteria:

• patient with anti-HIV Ac positive (latter result not older than 12 months and in the absence of risk factors)
• chronic liver disease due to other causes than HCV (hemochromatosis, autoimmune hepatitis, autoimmune disease, metabolic liver disease, alcoholic liver disease, alcoholic liver disease, exposure to toxins ...)
• chronic alcohol consumption >30g/day in men and >20g/day in women
• history of severe systemic disease,
• HCV treatment with anti-viral or anti-fibrotic referred to within the last 6 months,
• immunosuppressive therapy: corticosteroids, Imurel, cyclosporine, tacrolimus, Cellcep,
• patient with an active implantable medical device,
• protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health