IdB 1016 Treatment for Hepatitis C Disease

Inclusion Criteria:

• HCV infection according to ELISA-2
• Detectable HCV RNA PCR as measured within the previous 6 months
• Poor responders to, inadequate candidates for, or unwilling to use interferon-based therapies
• Serum ALT >= 1.3 times above normal
• Persistently elevated serum ALT levels according to two measures in the previous 12 months
• Evidence of stage II (periportal fibrosis), III (bridging fibrosis), or IV (compensated cirrhosis) in the Batts-Ludwig scoring system according to a liver biopsy performed in the last 2 (stage II and III patients) to 5 (stage IV patients) years. Patients with clinical signs of compensated cirrhosis (portal hypertension, non-bleeding varices) do not require a biopsy.
• Able and willing to follow protocol directions for the duration of the study
• Able and willing to maintain a consistent lifestyle routine (e.g., diet, exercise, medications, and dietary supplements) and sleep schedule for the duration of the study
• Able and willing to stop taking dietary supplements outside the study protocol for the duration of the study
• Able and willing to practice two methods of contraception during the study period, including the 4 week follow-up. This applies to women with childbearing potential and men whose sexual partners have childbearing potential.

Exclusion Criteria:

• Pregnant or breastfeeding
• Liver synthetic dysfunction (albumin < 3.2 g/dL, total bilirubin > 3.0 mg/dL, prothrombin time > 1.5 seconds prolonged)
• History of ascites, variceal bleeding, encephalopathy, jaundice, or extrahepatic biliary obstruction
• History of uncontrolled diabetes mellitus
• Known concomitant acute or chronic viral liver infections (e.g., hepatitis A, hepatitis B, Epstein-Barr, or cytomegalovirus)
• Concomitant autoimmune and inflammatory disease (e.g., rheumatoid arthritis, lupus)
• Other types of concomitant liver disease
• HIV-1 coinfection
• Chronic use of hepatotoxic drugs (e.g., acetaminophen)
• Interferon-based therapies in the past 6 months
• Alcohol consumption within 3 months prior to entry. Patients with a history of alcohol abuse should be at least 2 years into recovery.
• Use of recreational oral or IV drugs. Patients with a history of drug addiction should be at least 2 years into recovery.
• History of untreated malignancy
• Remission from previous malignant neoplasms <= 6 months
• History of significant renal, endocrine, cardiac, or pulmonary disease
• Use of supplements containing compounds derived from milk thistle
• Proven allergy to milk thistle or any derived compounds
• Subjects taking warfarin or coumadin due to silybin's potential interactions with cytochrome CYP 29C
• Any condition or concomitant medication or supplement that could hinder the outcomes of the study or the safety of the patient as determined by the principal investigator