Hepatitis C Antiviral Resistance in African-Americans

Inclusion:

- Age between 18 and 70 years at screening

- Black/African American or White/Caucasian

- Born in the United States

- Quantifiable Serum HCV RNA

- Hepatitis C genotype 1

- Liver biopsy consistent with chronic hepatitis C

- Negative urine pregnancy test

- Males and Females must be using two reliable forms of effective contraception while on
drug and during follow-up.

Exclusion:

- Previous treatment with interferon or ribavirin

- Positive test at screening for anti-HIV

- Positive test for HBsAg

- Alcohol consumption of more than two drinks/day

- History of other chronic liver disease

- Pregnant or breast-feeding women

- Male partners of women who are pregnant or contemplating pregnancy

- Neutrophil count <1000 cells/mm3

- Hgb <11 g/dl in women or 12 g/dl in men

- Platelet count <75,000 cells/mm3.

- Thalassemia, spherocytosis, history of GI bleeding or those at increased risk of
anemia

- Serum creatinine level >1.5 times the upper limit of normal at screening or CrCl <
75cc/min

- Current dialysis

- Alcohol or drug abuse within 6 months

- Current (<6 months)severe psychiatric disorder

- History of immunologically mediated disease

- Decompensated liver disease

- High risk cardiovascular/coronary artery disease

- Severe seizure disorder or anticonvulsant use

- Solid organ or bone marrow transplantation

- Thyroid disease poorly controlled on prescribed medications

- History or other evidence of retinopathy

- Chronic use of oral steroids

- Inability or unwillingness to provide informed consent or abide by the study protocol