24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C

Exclusion Criteria

• •Age less than 18 years
• •Women during pregnancy or breast-feeding
• •Previous treatment with PEG-IFN alpha2a or alpha2b + ribavirin for more than 6 months
• •Participation to any clinical trial within 30 days from enrollment in this protocol
• •Subjects with solid organ transplantation (with the exception of cornea or hair transplantation)
• •Subject not willing to have a counseling or to abstain from alcohol use
• •Suspected hypersensitivity to PEG-Interferon alpha2a or ribavirin
• •Any other cause of liver disease different from chronic hepatitis C based on anamnesis of patient or on histological evidence including but not limited to:
• •HBV coinfection
• •Alpha-1 antitrypsin deficiency
• •Wilson disease
• •Autoimmune hepatitis
• •Alcoholic liver disease
• •Hemoglobinopathy included but not limited to thalassemia major.
• •Advanced liver diseases diagnosed through history or presence of ascites, esophageal variceal bleeding or hepatic encephalopathy
• •Psychiatric conditions: depression or medical history of severe psychiatric alterations such as major psychosis, suicidal ideas, suicidal attempts, depression that required hospitalization or electroconvulsive therapy, prolonged work leave or significant impairment of everyday activities should be excluded. Subjects with history of slight depression might be considered for enrollment in the study if a pre-treatment psychiatric evaluation indicates that the subject is stable and that is possible to follow its mental status during the study.
• •Central nervous system trauma or convulsive status requiring treatment.
• •Cardiovascular diseases (e.g. angina, congestive heart disease, myocardial infarction, major arrhythmias).
• •Decompensated diabetes mellitus
• •Clinical gout
• •Chronic pulmonary diseases
• •Immune-mediated diseases (e.g. chronic inflammatory bowel diseases, idiopathic thrombocytopenic purpura, Systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
• •Abuse of substances such as alcohol (more than 80 g/die), i.v. or inhalator drugs. Subjects with a history of drug abuse can be enrolled if they were abstinent for at least 2 years.
• •Subjects with clinically relevant retinal lesions
• •Any other condition that at investigators opinion could be a reason of non suitability for patients or can interfere with his/her participation to the study.