Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC

• willing to give written informed consent and be able to adhere to dose and visit schedules.
• 18years of age or older of either gender and any race. Subjects who are over 65 years of age must be in generally good health.
• Serum positive for HCV-RNA by PCR assay Treatment naïve Genotype 1 \& 4 HCV participants
• ALT either elevated or persistently normal
• Liver biopsy within 36 months with a pathology report confirming the histological diagnosis is consistent with CHC

• Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit

  • Hemoglobin values of \<12 gm/dL for females \& \<13 gm/dL for males.
  • WBC \<3,000/mm3
  • Neutrophil count \< 1,500/mm3
  • Platelets \<65,000/mm3
  • Direct bilirubin, within 20% of (ULN)
  • Indirect bilirubin, WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise
• Albumin, WNL
• Serum creatinine, within 20% of ULN
• Glucose should be less than 115 mg/dL
• Thyroid Stimulating Hormone (TSH), WNL
• HIV negative
• HBsAg negative
• Alpha fetoprotein value \< 100 ng/mL obtained within one year prior to entry for patients with Stage 3 or 4 liver disease
• Reconfirmation \& documentation sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period \& 6 months following the last dose of study medication
• Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period \& for 6 months following the last dose of study medication

Exclusion Criteria:

• Women who are pregnant or nursing.
• Hepatitis C of non-genotype 1 or 4
• Previous anti-viral therapy
• Suspected hypersensitivity to interferon, PEG-interferon, ribavirin

• Any other cause for the liver disease other than chronic hepatitis C including but not limited to:

  • Co-infection with HBV
  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Obesity-induced liver disease
  • Drug-related liver disease
• Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy
• Hemoglobinopathies
• Evidence of advanced liver disease (ascites, bleeding varices,spontaneous encephalopathy)
• organ transplants other than cornea and hair transplant.
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
• CNS trauma or active seizure disorders requiring medication
• Significant cardiovascular dysfunction within the past 12 months. Subjects with ECG showing clinically significant abnormalities
• Poorly controlled DM
• Chronic pulmonary disease (COPD)with documented pulmonary hypertension
• Immunologically mediated disease (e.g., inflammatory bowel disease, RA, idiopathic thrombocytopenia purpura, lupus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis)
• Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids
• Active gout
• Substance abuse
• not willing to be abstain from the consumption of alcohol.
• clinically significant retinal abnormalities
• Any other condition that in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
• Known HIV Positive