TABLE 1.
Inclusion/Exclusion Criteria
| Inclusion criteria |
| Age 18 y or above |
| Male or female |
| Presence of hepatitis C virus (HCV) RNA (with or without anti-HCV) in serum |
| Any genotype of HCV |
| Any serum alanine (ALT) or aspartate (AST) aminotransferase |
| Must be able to provide written informed consent |
| No hemolysis at baseline based on serum haptoglobin and LDH |
| ESRD as defined by requiring dialysis |
| Exclusion criteria |
| Decompensated liver disease, as marked by bilirubin > 4 mg/dL, albumin < 3.0 g/dL, prothrombin time > 2 s prolonged, or history of bleeding esophageal varices, ascites, or hepatic encephalopathy |
| Significant systemic or major illnesses other than renal failure including active cardiac disease, reversible defects on cardiac imaging, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (HIV) infection, and angina pectoris will be excluded |
| Immunosuppressive therapy with either corticosteroids or major immunosuppressive agents |
| Patients with active excessive alcohol intake (> 50 g/d) |
| Evidence of another form of liver disease in addition to viral hepatitis (eg, autoimmune liver disease, Wilson disease, alcoholic liver disease, hemochromatosis, α-1-antitrypsin deficiency) |
| Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels > 50 ng/mL and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer will be excluded |
| Use of antiviral therapy within the last 6 mo |
| Evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease |
| Patients with active, serious autoimmune disease such as lupus erythematosis, ulcerative colitis, Crohn's disease, or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with α interferon will be excluded |
| Patients enrolled in other therapeutic trials |
| Pregnancy will be a contraindication. All females will have a urine pregnancy test and before starting ribavirin, and all sexually active patients will have to use 2 forms of contraception to ensure pregnancy does not occur |
| Any medical condition or medication, which increases the likelihood of hemolysis |
| Anemia with a hemoglobin below 9.5 g/dL of any etiology |