Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs

Study Overview
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Brief Summary
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This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood. The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.

Detailed Description
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This study is designed to obtain and store samples of serum and liver tissue in HCV-infected patients being treated with DAA therapy. A liver biopsy will be performed pre-treatment for research reasons. A small liver sample that is not required for pathologic analysis will also be stored. Patients will undergo another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy. Any patients with HCV-related liver disease (age > 18) will be considered for this study. Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment. The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using molecular techniques to measure transcription of key genes involved in the antiviral response.

Official Title
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Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs

Conditions
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Hepatitis C

Intervention / Treatment
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* Procedure: Liver Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Signed informed consent Ages 18-70 HCV-infected patients being treated with direct-acting antiviral (DAA) therapy. Exclusion Criteria Pregnant women or females of childbearing potential that are not on contraception Institutionalized or mentally disabled persons Prisoners Unwilling or unable to provide informed consent Subjects who are HIV positive Anticipated inability to follow up Chronic anemia Platelet count < 100 for liver biopsy patients who have documented fatty liver disease by ultrasound prior to enrollment Any patient with bleeding disorders or prolonged INR Abstinent or consuming less than two drinks of alcohol per day. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Patients who will have their second Liver biopsy at week 4<br>The 4 week time point is performed in lieu of the 12 week and the purpose of this time point is to evaluate earlier responses and transcriptional changes that might predict viral clearance or treatment failure in a subset of patients. | Procedure: Liver Biopsy<br>* patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.<br>|
| Patients who will have their second Liver biopsy at week 12<br>Liver biopsies will be obtained at week 12 when most DAA treatments end in order to compare the hepatic responses induced or reduced by clearance of HCV | Procedure: Liver Biopsy<br>* patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gene array from baseline to either 4 or 12 weeks after treatment. | To examine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV