Differences in Evoked Intracellular Interferon Signaling Pathways Using Single Cell Phosphoprotein Profiling

Inclusion criteria

To be eligible for this study, subjects must meet the following inclusion criteria:

• Willing and able to provide informed consent
• Males or females age 18 - 65 years
• For women of childbearing potential, negative blood pregnancy test documented within the 24-hour period prior to IFN-α administration
• History of genotype 1 HCV infection previously treated with peginterferon and ribavirin and with a virological response that can be determined from retrospective review of medical records
• A washout period of >12 weeks between the last dose of prescribed peginterferon and ribavirin and the screening visit

Exclusion criteria

Subjects with any of the following will not be eligible for participation:

• Neutrophil count <1500 cells/mm3, Hgb <12 g/dL in women or 13 g/dL in men, or platelet count <75,000 cells/mm3 at screening
• Serum creatinine level >1.5 times the upper limit of normal at screening
• Poorly controlled psychiatric illness, as determined by the study physician, which can be exacerbated by interferon therapy
• Infection requiring antibiotics, symptomatic viral infection, inflammatory process requiring therapy, or allergic reactions in the week immediately preceding the inpatient study visit
• Use of medications that affect the immune system (e.g. glucocorticoids, chronic NSAIDs daily) in the week immediately preceding the inpatient study visit
• History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, psoriasis, rheumatoid arthritis)
• Women with ongoing pregnancy or breast-feeding
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• History of a seizure disorder or current anticonvulsant use
• History of major organ transplantation with an existing functional graft
• History of thyroid disease poorly controlled on prescribed medications
• History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study