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Improved diagnostic accuracy of blood tests for severe fibrosis and cirrhosis in chronic hepatitis C

19.01.2018

 

Interview of Dr. Jérôme Boursier, Hepatogastroenterology Department, Angers Hospital, France

 

 

 

Could you briefly tell us about the main objectives of your study?

Why did you choose to focus on these objectives?

 

Blood tests for fibrosis have generally been designed for the diagnosis of significant fibrosis METAVIR F≥2. Why? Because that is an important diagnostic target for the treatment of patients with chronic Hepatitis C. It represents the indication for anti-viral C treatment.

Several studies have shown that these blood tests for fibrosis performed well for the diagnosis of significant fibrosis.

There is another diagnostic target that is equally important for the treatment of patients with chronic Hepatitis C: that is the diagnosis of cirrhosis, because that requires the implementation of screening procedures, most notably for hepatocellular carcinoma and oesophageal varicose veins.

In a previous study, we evaluated the performance of blood tests for fibrosis initially designed for the diagnosis of significant fibrosis, this time to diagnose fibrosis, and we showed that their performance left room for improvement.

The aim of this study was therefore to evaluate the performance of blood tests in diagnosing cirrhosis, and to try to improve it.

 

Could you present the inclusion criteria and also the targeted population?

Why did you chose these criteria?

 

For this study, we included 1 056 patients with chronic hepatitis C, for whom the results of a blood test with fibrosis markers and a liver biopsy were available. This was a French multicentric study covering nine centers. Stage F of METAVIR evaluated according to the liver biopsy was the reference for the diagnosis of fibrosis.

 

Could you briefly outline the results?

 

First, we sought to evaluate the diagnostic performance with regard to cirrhosis of the blood tests initially designed to diagnose significant fibrosis. These blood tests performed well for the diagnosis of cirrhosis, most notably with AUROCs reaching 0.880 for the tests recommended by the HAS (French Health Authority).

Next, we attempted to improve the performance of the blood tests for the diagnosis of cirrhosis. In a multivariate analysis aiming to identify the blood markers independently related to the diagnosis of cirrhosis, the parameters identified were the same as those included in the FibroMeter™ blood test.

These parameters were combined in a new blood test dedicated to the diagnosis of cirrhosis: the CirrhoMeter™.

The CirrhoMeter™ had the advantage of improving the overall performance for the diagnosis of cirrhosis with an AUROC of 0.919 and increasing the proportion of correctly classified patients and the sensitivity for the diagnosis of cirrhosis.

Finally, it was possible to confirm the diagnosis of cirrhosis in a small proportion of patients with 100% diagnostic accuracy using the CirrhoMeter™.

 

Which key points of the study are to be remembered?

In conclusion, what improvements will your study bring to clinical practice and patients?

 

Compared to the traditional blood tests, particularly those recommended by the HAS, a blood test built to diagnose cirrhosis can improve diagnostic performance. Because CirrhoMeter™ includes the same blood markers as FibroMeter ™, both tests can be computed at the same time.

The clinical therefore has two tools: FibroMeter™, which gives the probability of significant fibrosis, and CirrhoMeter™ which gives the probability of cirrhosis. These two tests are therefore complementary. More recently, we evaluated the performance of blood tests for fibrosis in determining the prognosis for patients with chronic Hepatitis C. We showed that the traditional blood tests performed well to determine the prognosis, and that the CirrhoMeter™ could improve the prediction of hepatic events related to chronic Hepatitis C, showing that these tests are in fact complementary.

 

 

Boursier J, Bacq Y, Halfon P, Leroy V, de Ledinghen V, de Muret A, Bourlière M, Sturm N, Foucher J, Oberti F, Rousselet MC, Calès P. European Journal of Gastroenterology & Hepatology. 2009;21(1):28-38.