Hepatitis C Antiviral Resistance in African-Americans
Hepatitis C

About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco
- University of Miami School of Medicine
- Rush University
- University of Maryland School of Medicine
- Beth Israel Deaconess Medical Center
- University of Michigan Medical Center
- New York-Presbyterian Medical Center
- University of North Carolina
Arms of the Study
Arm 1
Experimental
Interferon and rivavirin
All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily.