Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

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