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