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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hepatitis C

Treatments: Procedure: Liver Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02532907

14-1794

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

5 participants in 2 patient groups

Patients who will have their second Liver biopsy at week 4

Description:

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.

Treatment:

Procedure: Liver Biopsy

Patients who will have their second Liver biopsy at week 12

Description:

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

Treatment:

Procedure: Liver Biopsy