Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)
Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)
The purposes of this study are:

 1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to
 standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and
 HVL

 2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is
 superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at
 week 12
The aims of the present study are:

 1. To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS®
 (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C
 virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads
 (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic
 response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment)

 2. To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus
 standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients with
 PCR-seropositive of HCV RNA at week 12
Inclusion Criteria:

 -  Male and female patients *18 years of age

 -  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 and HCV viral genotype 1

 -  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

 -  Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including
 supraphysiologic doses of steroids and radiation) *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)

 -  Signs or symptoms 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