Data Collection

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,...

Unique Features

CDISC compliant database allowing the data to be shared directly with the FDA for analyses around safety and efficacy as part of a formal MOU (#225-13-0012) executed in 2013. HCV-TARGET developed standardized, centralized chart data abstraction methods along data...

Aims

Primary aims: Safety and efficacy in populations represented and underrepresented in phase III clinical trials African Americans / Hispanics, cirrhosis, null responders, age > 65, transplant Subgroup analyses to determine the cumulative influence of IL28B,...

Phase 2

Longitudinal, observational study Prospective and sequential Inclusion criteria: Adult patients (≥ 18 years) being treated with any anti-HCV regimen outside of a clinical trial Exclusion criteria: Inability to provide written informed consent Biorepository: baseline...

Phase 1

Longitudinal, observational study Inclusion criteria: All adult patients (older than age 18) being treated with antiviral regimens that contain telaprevir or boceprevir Ability to provide written informed consent for participation Exclusion criteria: Inability to...

Hypothesis

A carefully maintained longitudinal, observational study of patients treated with telaprevir and boceprevir within academic and real-world community practices can rapidly inform strategies: For better management of populations both represented and underrepresented in...