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

Secondary Aims:

  • Safety and efficacy in special populations
    • HIV/HCV co-infection, pre-liver transplantation (decompensated cirrhosis), post liver transplantation, renal failure, genotype 2 and 4 patients
  • PEG-IFN 2a / 2b with different PIs + lead-in
  • Frequency and impact of switching PIs
  • Surveillance of drug-drug interactions
  • Measurement of treatment adherence
  • Impact of pretreatment education
  • Impact of specialty pharmacy