Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C

The study will include patients who are diagnosed with chronic hepatitis C genotype 1
infection and who have received no previous interferon or other anti-HCV treatment.

Inclusion Criteria:

- Signed patient consent form

- Genotype 1 chronic HCV with detectable HCV RNA

- No previous treatment for HCV infection

- Hepatitis B and human immunodeficiency virus negative at screening visit

- Able and willing to follow contraception requirements

- Screening laboratory values, test, and physical exam within acceptable ranges

- Weight between 40 kg and 125 kg

- Proficiency in the use of the external pump infusion system

Exclusion Criteria:

- Current or planned enrollment in another investigational device or drug study

- Anticipated inability to complete all clinic visits and comply with study procedures

- History of, or any current medical condition, which could impact the safety of the
subject during the study

- Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease,
or other known liver disease other than HCV

- Alcoholism or substance abuse with <6 documented months of sobriety

- Known allergy or sensitivity to interferons or ribavirin

- 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 study