Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine

Exclusion Criteria

• •Women with ongoing pregnancy or breast feeding.
• •Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBe Ag.
• •Positive test at screening for HIV.
• •History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
• •Hypersensitivity to study drugs.
• •Participation in any other clinical trial within 30 days of entry into this protocol.
• •Treatment with any investigational drug within 30 days of entry into this protocol.
• •History or evidence of decompensated liver disease (Child-Pugh B/C) and a Child-Pugh score \>5. Ascites, coagulopathy, hyperbilirubinemia, hepatic encephalopathy, or hypoalbuminemia and a Child-Pugh score \>5 are conditions consistent with decompensated liver disease.
• •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.
• •Hepatocellular carcinoma (HCC) or α-Fetoprotein \>50μg/l.
• •Patients with organ transplants other than cornea and hair transplant.
• •Therapy with any antisystemic or immunomodulatory treatment (including supra-physiologic doses of steroids or radiation) \<6 months prior the first dose of study drug
• •Hemoglobinopathy (e.g. thalassemia) or any other cause of or tendency for hemolysis.
• •Any known preexisting medical condition that could interfere with the patient's participation in and completion of the study such as:
• •Preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychosis, suicidal ideation and/or suicidal attempts (based on a mandatory psychiatric advice).
• •CNS trauma or active seizure disorders requiring medication.
• •Significant cardiovascular dysfunction.
• •Poorly controlled diabetes mellitus.
• •Renal dysfunction, i.e. serum creatinine levels \>1.5 times upper limit of normal.
• •Autoimmune diseases.
• •Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration).
• •Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
• •Clinical gout.
• •Important substance abuse (alcohol \>80 g/d, i.v. drugs etc.).
• •Active opportunistic infections.
• •Non-Hodgkin lymphoma or Hodgkin lymphoma.
• •Kaposi sarcoma.
• •Inability or unwillingness to provide informed consent or abide by the requirements of the study.
• •Male partners of pregnant women.