Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

Inclusion Criteria:

• Relapsers to previous combination therapy with (PEG-)IFN alfa-/Ribavirin and a negative HCV-RNA test result at the end of this regular treatment course and positive HCV-RNA test result during the follow-up period.
• Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment
• Chronic HCV infection genotype 1 or 3.
• Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU)
• Compensated liver disease (Child-Pugh A)
• Exclusion of HCC in patients with cirrhosis or transition to cirrhosis. In patients with AFP >50 ng/mL an established assay for exclusion of HCC has to be done
• Negative urine or blood pregnancy test
• All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment

Exclusion Criteria (at screening):

• Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs
• Ongoing pregnancy or breast feeding
• Male partners of women who are pregnant or with women without effective contraception
• Signs or symptoms of hepatocellular carcinoma
• Chronic HCV infection genotype 2, 4, 5 or 6
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment < 6 months prior to the first dose of study drug and during study period. Exception: patients who have had a limited (< 7 days) course of acyclovir or valacyclovir for herpetic lesions < 1 month prior to the first administration of test drug are not excluded.
• Any investigational drug < 6 weeks prior to the first dose of study drug
• Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV
• History or other evidence of a medical condition associated with chronic liver disease other than HCV
• History or other evidence of decompensated liver disease or a Child-Pugh score > 6.
• Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening
• Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic
• Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3
• Serum creatinin concentration >1.5 mg/dl
• History of severe psychiatric disease, especially depression.
• History of a severe seizure disorder that can not be stabilized by medication
• History of immunologically mediated disease
• Chronic pulmonary disease associated with functional limitation
• History of severe cardiac disease
• History of major organ transplantation except corneatransplantation
• Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• Thyroid dysfunction not adequately controlled
• Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
• Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution
• Take of Memantine during study period
• Cardiomyopathy and myocarditis
• AV-Block II° and III°
• Pre-existing bradycardia < 55 counts/min
• Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome
• History of severe ventricular arrhythmia incl. Torsade de pointes
• Simultaneous therapy with Budipin or other medicine that extend the QT-interval like (e.g.antiarrhythmic drugs class IA and class III, antipsychotic drugs, tri- and tetracyclic antidepressants, antihistaminics, macrolide, gyrase inhibitors, Azol-antimykotics)
• Patients with obstructive glaucoma
• Patients with excitableness and confusion
• Patients with delirium and exogenic psychosis in the anamnesis
• Prostataadenome
• Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide
• Inability or unwillingness to provide informed consent or abide by the requirements of the study