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 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