Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Males or females, 18 to 55 years of age who are diagnosed with HCV by PCR
HCV treatment-naïve patients who have already committed to undergo standard of care therapy (SOC) for HCV (pegylated interferon and ribavirin), and who wish to participate in a study immediately prior to the initiation of SOC
Chronic hepatitis C infection, genotype 1 or genotype 2, two documented tests (PCR or HCV Ab; if one of the tests is HCV Ab, then the second test must be PCR and the PCR test must be at least 6 months after the HCV Ab test) at least 6 months apart
Liver biopsy within the last two (2) years (biopsy can be done at the Screening Visit)
Positive viral load of <1,000,000 IU/mL as measured by quantitative PCR
Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality and a QT/QTc interval <450 milliseconds - using Bazett's correction: QTc =QT/RR0.5 (ICH Guidance E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs)

Females of childbearing potential (intact uterus and within 1 year since the last menstrual period) should be non-lactating and have a negative serum pregnancy test. In addition, these subjects should agree to use one of the following acceptable birth control methods throughout the study:

abstinence
surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six months minimum
IUD in place for at least six months
barrier methods (condom or diaphragm) with spermicide
surgical sterilization of the partner (vasectomy for six months)
hormonal contraceptives for at least three months prior to the first dose of study drug
Willing and able to comply with study procedures and provide written informed consent

Exclusion Criteria:

Participation in a clinical trial with or use of any investigational agent within 30 days of Study Visit 1
Patients co-infected with HIV
Patients with screening tests positive for HBsAg, or anti-HIV Ab
Liver biopsy within the last 2 years that shows Stage III fibrosis or higher
Clinical evidence or suspicion of cirrhosis
Active jaundice defined by total bilirubin >2.0
INR ≥ 1.5
Eating disorder or alcohol abuse within the past 2 years, excessive alcohol intake (>20 g per day for females (1.5 standard alcohol drinks) or >30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) (1.0 fluid oz (US) = 29.57 ml), or if in the opinion of the investigator, an alcohol use pattern that will interfere with the study conduct
Drug abuse within the last six months with the exception of cannabinoids and their derivatives
Patients with absolute neutrophil count (ANC) <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; abnormal TSH,T4, or T3or thyroid function not adequately controlled; or serum creatinine concentration ≥1.5 times upper limit of normal (ULN)

History or clinical evidence of any of the following:

variceal bleeding, ascites, hepatic encephalopathy, CTP score >6, decompensated liver disease or any other form of non-viral hepatitis
immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring more than intermittent nonsteroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids (inhaled asthma medications are allowed)
any malignancy within 3 years except for basal cell skin cancer
significant or unstable cardiac disease (e.g., angina, congestive heart failure, uncontrolled hypertension, history of arrhythmia)
chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment
severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
Patients with a body mass index >30 kg/m2
Concomitant drugs known to prolong the QT interval (see Appendix E)
Concomitant use of immunosuppressive or immune modulating agents
Patients with any serious or condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed or increase the risk to the subject of participation in the trial