Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV

Exclusion Criteria

• •Pregnant or breast feeding women or women who may wish to become pregnant during the study or within 30 days of study drug administration.
• •Males who have partners planning to become pregnant within 30 days of study drug administration.
• •Males and females of reproductive potential who are unwilling to use effective method(s) of birth control for a minimum of 30 days after ingestion of study medication
• •Coinfection with hepatitis B virus (HBV) or HIV
• •Known liver disease of a non-HCV etiology
• •Pancreatitis
• •Autoimmune disease
• •History of malignancy
• •Ongoing alcohol abuse.
• •Recent significant infection or symptoms of infection
• •Evidence of hepatocellular carcinoma (e.g., a-fetoprotein \> 50 ng/mL or as indicated by recent ultrasound)
• •Decompensated liver disease OR history of clinical hepatic decompensation
• •Hb \< 10 g/dL
• •Absolute neutrophil count (ANC) \< 1,000 cells/mm3
• •Therapy with potentially hepatotoxic/cholestatic drugs.
• •Therapy with agents having potential hepatic anti-inflammatory or anti-fibrotic properties.
• •Therapy with proton pump inhibitors or histamine-2 receptor antagonists.
• •Have received therapy with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 90 days prior to Day 1 or are expected to receive such therapy during the study.
• •With or a history of clinically significant illness or medical disorder that may interfere with treatment, assessment or compliance.
• •Have a history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility.
• •Received study medication while participating in another research study within 60 days prior to Day 1.
• •A positive urine drug screen
• •Known hypersensitivity to the study drugs, the metabolites or formulation excipients.
• •Known aspirin allergy.