INCLUSION CRITERIA:
Age 18 years or above, male or female
Documented relapse or non-response to a prior adequate course of peginterferon and ribavirin
Genotype 1 HCV as determined by probe specific hybridization (Inno-Lipa assay).
Written informed consent.
EXCLUSION CRITERIA:
Age greater than 65 years
If cirrhosis is present, decompensated liver disease, as marked by serum bilirubin greater than 4 mg percent, albumin less than 3.0 gm percent, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
Serum ALT or AST levels greater than 1000 U/L (greater than 25 times ULN). Such patients will not be enrolled but may be followed until three determinations are below this level.
Pregnancy or, in women of child bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermacide, or birth control pills, or an intrauterine device.
Breastfeeding.
Significant systemic or major illnesses including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (HIV) infection, and angina pectoris.
Previous intolerance of weight based ribavirin dose (1,000-1,200 mg daily) including need for dose reduction, use of erythropoietin or serious adverse event attributable to ribavirin use.
Renal insufficiency (creatinine clearance less than 60 ml/min) or renal failure
Pre existing anemia (hematocrit less than 36 percent) or known history of hemolytic anemia.
Uncontrolled hypertension or diabetes mellitus
Other antiviral therapy within the last 6 months.
Immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine).
Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson disease, alcoholic liver disease, hemochromatosis, alpha 1 antitrypsin deficiency).
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.
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
Clinical gout.
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 peginterferon.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/15/2008