Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
Age ≥ 18 years
Compensated liver disease (Child-Pugh Grade A clinical classification)
Negative urine or blood pregnancy test (one of the both; for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and > 10.6 mg/kg ribavirin (Rebetol®)
No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

Exclusion Criteria:

Women with ongoing pregnancy or breast feeding
Male partners of women who are pregnant
Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
Absolute neutrophil count (ANC) <750 cells/mm3 at screening
Platelet count <50,000 cells/mm3 at screening
Hb <10 g/dl at screening
Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
Serum creatinine level >1.5 times the upper limit of normal at screening
History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
History of a severe seizure disorder or current anticonvulsant use
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
History or any other evidence of autoimmune diseases
History or other evidence of chronic pulmonary disease associated with functional limitation
History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
Evidence of thyroid disease that is poorly controlled on prescribed medications
Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
History of major organ transplantation with an existing functional graft
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
Patients with evidence for tuberculosis
Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
Limited contractual capability