Long-term Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation: a Multicenter Study of Hepatocellular Carcinoma Prevention in Patients Non-responders to Combined Therapy With Alpha Interferon + Ribavirin or Peginterferon Alpha + Ribavirin or to Interferon Monotherapy
Inclusion Criteria:
- Cirrhotic participants, both sexes, Child Pugh A, B, HCV-RNA positive, age < 70 years
- Participants non-responders to IFN + Ribavirin or PegIFN + Ribavirin or IFN
monotherapy
- Pre-therapy liver biopsy (< 36 months) with PCNA-LI > 2.0
- Fibrosis score 5-6 (Ishak)
- Initial portal hypertension, such as gastroesophageal varices or one of the following
US sign:
- Collateral circles
- Spleen longitudinal diameter > 12 cm
- Portal vein diameter at hilus > 12 mm
- Portal flow > 12 cm/sec
- Participants must have the following minimum hematologic and biochemical
criteria:
- Hemoglobin >= 11 g/dL
- Granulocyte count > 1,000/mm^3
- Platelets > 70,000/mm^3
- Prothrombin activity > 50%
- Total bilirubin <3 mg/dL
- Albumin >= 3.5 g/dL
- Serum creatinine within normal limits
- Uric Acid within normal limits
- Thyroid Stimulating Hormone (TSH), within normal limits
- Antinuclear antibodies (ANA) < 1:160
- Written informed consent
- Women of childbearing potential must have a negative pregnancy test
- Acceptance of patients of both sexes of proper contraceptive measures for the study
period
Exclusion Criteria:
- Pregnant or breast-feeding women
- Co-infection with HIV and/or HBV
- Autoimmune hepatitis or history of autoimmune disease
- Alcoholic liver disease
- Metabolic disease
- HCC
- Participants with liver and kidney transplants
- Evidence of decompensated liver disease such as history or presence of ascites,
bleeding varices, spontaneous encephalopathy
- Chronic renal failure or creatinine clearance < 50 mL/min
- Pre-existing thyroid disease unless it can be controlled with conventional treatment
- History or presence of psychiatric condition, especially depression, or a history of
severe psychiatric disorder, such as major psychoses, suicidal ideation and/or
suicidal attempt
- Epilepsy and/or compromised central nervous system (CNS) function
- Significant cardiovascular dysfunction within the previous 6 months before the study
starts (eg, angina, congestive heart failure, recent myocardial infarction, moderate
or severe hypertension, significant arrhythmia)
- Hemoglobinopathies
- Poorly controlled diabetes mellitus
- Chronic pulmonary disease (eg, chronic obstructive pulmonary disease)
- Clinical gout
- Hypersensitivity to interferons or any component of the drug