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

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.

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).