Liver Elastography in Patients Undergoing Treatment for Hepatitis C

Study Overview
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Brief Summary
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According to the guidelines for treating hepatitis C livers stiffness (LS) measurement is equivalent to liver biopsy to prove grade-2 fibrosis or more by Metavir-score. Also flares of inflammation in other viral hepatitis (B) have been reported to increase the elastography measurements. There are very few reports so far on longitudinal data in a treatment cohort. In this study investigators will follow patients who undergo active treatment for hepatitis C virus (HCV). Investigators will collect longitudinal data of liver elastography and compare this to the current status of liver inflammation by blood samples. This may be important in order to know if transcutaneous US with elastography can be used as a tool to monitor active inflammation in liver disease and to quantify how much the inflammatory component contribute to LS and finally if it is possible to reverse not only inflammation but also liver fibrosis by treating viral hepatitis. Our aim is to assess shear wave elastography (SWE) and investigate if the method can be used, not only to define the indication for treatment through LS measurements, but also if LS due to inflammation and fibrosis may be reversible in treated patients. To investigate what role frequency of measurement obtains in follow up of patients with HCV play.

Official Title
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Liver Elastography in Patients Undergoing Treatment for Hepatitis C - a Longitudinal Study

Conditions
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Hepatitis C Virus Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with HCV HCV RNA positive Approved for HCV treatment Exclusion Criteria: Excessive alcohol use Pregnancy information of other cause of chronic liver disease (autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Alpha-1-antitrypsin deficiency).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elastography | Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment. | Baseline | 
| Patient record | weight and height will be combined to report BMI in kg/m^2 at baseline of participants receiving antiviral treatment. | Baseline | 
| Biochemical analyses | Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including AST to Platelet Ratio Index (APRI) and Fibrosis-4 index (FIB-4)will be calculated, at baseline of participants receiving antiviral treatment. | Baseline | 
| B-mode evaluation of the liver | Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at baseline of participants receiving antiviral treatment. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elastography | Obtained liver stiffness measurements (kPa) after end treatment (EOT). | 3 months | 
| Elastography | Obtained liver stiffness measurements (kPa), 3 months after end of treatment (EOT). | 6 months | 
| Elastography | Obtained liver stiffness measurements (kPa), 1 year after EOT. | 12 months | 
| B-mode evaluation of the liver | Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at at end of treatment (EOT). | 3 months | 
| B-mode evaluation of the liver | Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 3 months after end treatment (EOT). | 6 months | 
| B-mode evaluation of the liver | Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 1 year after EOT. | 12 months | 
| Patient record | weight and height will be combined to report BMI in kg/m^2 at end of treatment (EOT). | 3 months | 
| Patient record | weight and height will be combined to report BMI in kg/m^2, 3 months after end treatment (EOT). | 6 months | 
| Patient record | weight and height will be combined to report BMI in kg/m^2, 1 year after EOT. | 12 months | 
| Biochemical analyses | Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including APRI and FIB-4 index will be calculated, at end of treatment (EOT). | 3 months | 
| Biochemical analyses | Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including APRI and FIB-4 index will be calculated, 3 months after EOT. | 6 months | 
| Biochemical analyses | Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including APRI and FIB-4 index will be calculated, 1 year after EOT. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Shear wave elastography, SWE, Hepatitis C, HCV