- 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 DNA and serum at key timepoints
- Serum at baseline and evidence of viral failure (non-response/breakthrough/relapse)
- DNA, single specimen at any time point
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, fibrosis, viral subtype (1a vs 1b), other co-morbidities
- Prior DAA containing regimen failures
- Refine/Define point estimates and narrow/define confidence intervals for SVR
- Adverse event surveillance and management
- Drug-drug interactions
- Virologic breakthrough and resistance
- Biorepository sample collection
- Impact of viral load measurement on treatment efficacy
- Evaluate/inform FDA pharmacometric modeling
- Unstudied populations and dosing regimens
- Long Term Health Outcomes (annually after SVR determination)
- Impact of SVR/lack of SVR on HCV co-morbidities
- Persistence of existing co-morbid conditions
- Development of new co-morbid conditions
- Patient centered outcomes research
- Under development and to be piloted at select sites in 2015
