Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C

Study Overview
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Brief Summary
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Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).

Official Title
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New AbbVie Direct Acting Antiviral (DAA) Treatment of Chronic Hepatitis C Infection - Effects on the Macrophage Activation Marker Soluble CD163, Portal Hypertension, and Metabolic Liver Function

Conditions
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Hepatitis C

Intervention / Treatment
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* Procedure: Functional Hepatic Nitrogen Clearance (FHNC)
* Procedure: Galactose Elimination Capacity (GEC)
* Procedure: Liver vein catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin) Child-Pugh A liver cirrhosis Exclusion Criteria: Severe liver dysfunction - Child-Pugh klasse B-C Life expectancy less than 6 months planned liver transplantation or TIPS procedure within 6 months non-compliance to treatment or study procedures allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin) pregnancy or expected pregnancy during the study (anti-conception has to be used) breast feeding portal vein thrombosis liver cancer or other malignancies alcohol consumption

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AbbVie<br> | Procedure: Functional Hepatic Nitrogen Clearance (FHNC)<br> <br> Procedure: Galactose Elimination Capacity (GEC)<br> <br> Procedure: Liver vein catheterization<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks |  | 12 weeks | 
| Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the levels of the macrophage specific activation marker sCD163 |  | Before, during and after treatment - 60 weeks | 
| Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test |  | After 12 weeks treatment | 
| Changes in the functional hepatic nitrogen clearance (FHNC) |  | After 12 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct acting antiviral treatment, sCD163, Portal hypertension, Metabolic liver function, Cirrhosis