Patients are enrolled prospectively at participating sites and treated per local standard of care. HCV-TARGET does not define treatment regimens, dosing, or duration or safety management practices. Source data is the original medical record. All original clinic notes, telephone notes, safety and efficacy labs/evaluations collected during treatment and in the post treatment observation period are submitted to a central data repository. Pertinent data from submitted records is abstracted by specially trained staff at the HCV-TARGET clinical coordinating center. Some data is mapped directly from electronic medical records into the database using the REDCap Eletronic Data Importer (RED-I) software.
- Demographics (gender, age, race, ethnicity, BMI, type of insurance)
- Baseline factors (HCV viral load, HCV genotype, cirrhosis determination, IL-28b genotypes, prior HCV treatment, medical history, co-morbid conditions)
- HCV treatment regimen and dose adjustments
- Adverse Events
- Concomitant Medications
- Labs to monitor safety and efficacy
- Long-term post treatment FU (co-morbid conditions, complications related to liver disease, mortality)