Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C

University of Aarhus

Status: Completed

Conditions: Hepatitis C

Treatments: Procedure: Fibroscan; Drug: Galactose; Procedure: Gastroscopy; Drug: Sofosbuvir; Procedure: Liver biopsy; Procedure: Liver vein catheterization

Study type: Observational

Funder types: Other

Identifiers

NCT02528461

HCV sCD163 Sofosbuvir

Details and patient eligibility

About

The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.

In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.

Enrollment: 71 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment

Exclusion criteria

• HIV or Hepatitis B Virus

Trial design

71 participants in 1 patient group

Sofosbuvir

Description:

All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study. All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.

Treatment:

Procedure: Gastroscopy

Drug: Sofosbuvir

Procedure: Liver vein catheterization

Procedure: Fibroscan

Procedure: Liver biopsy

Drug: Galactose