Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)

Inclusion criteria

Subjects will be enrolled based on prior enrollment in the BMS 986094 studies or treatment-naïve HCV subjects with no known cardiovascular abnormalities.

• All Subjects must give informed consent prior to participation in the study.
• Subject participated in the Phase 1 or Phase 2 trials with BMS 986094 (including placebo arm) OR
• Subject with known hepatitis C (Control)

• No previous exposure to BMS 986094
• Treatment naive at study entry (No prior hepatitis C treatment experience at the time of enrollment, including but not limited to: standard interferon, pegylated interferon, ribavirin, boceprevir, telaprevir, or other experimental drugs for hepatitis C).

Exclusion criteria

• For subjects who participated in the Phase 1 or Phase 2 trials with BMS 986094, there are no exclusion criteria
• For the control group of subjects without exposure to BMS 986094, the following exclusion criteria, based on clinically available data, apply:

• Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin >2, ALT or AST laboratory values ≥ 10 times the upper limit of normal, or other evidence of decompensated liver disease or hepatocellular carcinoma
• Chronic liver disease other than HCV not limited to Hepatitis B virus (positive test for HBsAg), hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease
• History of liver transplantation
• Co-infection with HIV (positive test for anti-HIV Ab)
• Prior history of cardiomyopathy (ejection fraction ≤ 50%) or history of heart failure
• Signs or symptoms of decompensated heart failure or
• Prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)