IdB 1016 Treatment for Hepatitis C Disease

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