Hepatitis C Antiviral Resistance in African-Americans

Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)

This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.

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