Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the
 treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The
 efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its
 impact on the outcome in chronic hepatitis C patients concomitant with malignancy other than
 hepatocellular carcinoma deserve to be elucidated.

 The purposes of this study are:

 1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin
 combination therapy in chronic hepatitis C patients concomitant with malignancy other
 than hepatocellular carcinoma, compare to those without systemic malignancy.

 2. To investigate the role of baseline and on-treatment factors on the response to
 pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C
 patients concomitant with malignancy other than hepatocellular carcinoma.
A prospective, hospital-based study enrolling 40 chronic hepatitis C patients concomitant
 with malignancy other than hepatocellular carcinoma and other sex- and age-matched 80 chronic
 hepatitis C patients without malignancy will be conducted. The 40 chronic hepatitis C
 patients concomitant with malignancy other than hepatocellular carcinoma will receive
 pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after
 oncological treatments and/or interventions. The other 80 chronic hepatitis C patients
 without malignancy receiving the same antiviral therapy will serve as controls. The primary
 outcome measurement is sustained virological response and safety, whilst the secondary
 measurement is rapid virological and early virological response.
Inclusion Criteria:

 -  Male and female patients >18 years of age

 -  Local or Systemic malignancy other than hepatocellular carcinoma in remission or
 stable status

 -  Patients have never been treated with traditional interferon plus ribavirin or
 peginterferon plus ribavirin

 -  Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test

 -  Detectable serum HCV-RNA

 -  Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection
 with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is
 medically contra-indicated do not require biopsy.)

 -  Compensated liver disease (Child-Pugh Grade A clinical classification)

 -  Negative urine or blood pregnancy test (for women of childbearing potential)
 documented within the 24-hour period prior to the first dose of study drug

 -  All fertile males and females receiving ribavirin must be using two forms of effective
 contraception during treatment and during the 6 months after treatment end

 Exclusion Criteria:

 -  Women with ongoing pregnancy or breast feeding

 -  Present therapy with any systemic anti-neoplastic or immunomodulatory treatment
 (including supraphysiologic doses of steroids and radiation) within 6 months prior to
 the first dose of study drug

 -  Any investigational drug 6 weeks prior to the first dose of study drug

 -  Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus
 (HIV)

 -  History or other evidence of a medical condition associated with chronic liver disease
 other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease,
 alcoholic liver disease, toxin exposures)

 -  Clinical evidence of hepatocellular carcinoma

 -  History or other evidence of bleeding from esophageal varices or other conditions
 consistent with decompensated liver disease

 -  Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening

 -  Serum creatinine level >1.5 times the upper limit of normal at screening

 -  History of severe psychiatric disease, especially depression. 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 or any history of the following: a suicidal
 attempt, hospitalization for psychiatric disease, or a period of disability due to a
 psychiatric disease

 -  History of a severe seizure disorder or current anticonvulsant use

 -  History of immunologically mediated disease, chronic pulmonary disease associated with
 functional limitation, severe cardiac disease, major organ transplantation or other
 evidence of severe illness, or any other conditions which would make the patient, in
 the opinion of the investigator, unsuitable for the study

 -  History of thyroid disease poorly controlled on prescribed medications, elevated
 thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to
 thyroid peroxidase and any clinical manifestations of thyroid disease

 -  Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)

 -  Evidence of drug abuse (including excessive alcohol consumption>40 g/day) within one
 year of study entry

 -  Inability or unwillingness to provide informed consent or abide by the requirements of
 the study

 -  Male partners of women who are pregnant

 -  Hgb <11 g/dL in women or <12 g/dL in men at screening

 -  Any patient with major thalassemia

 -  Patients with documented or presumed coronary artery disease or cerebrovascular
 disease should not be enrolled if, in the judgment of the investigator, an acute
 decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would
 not be well-tolerated

 -  Evidence or history of hepatocellular carcinoma

 -  Local or Systemic malignancy unstable status