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 provide written informed consent
  • Biorepository: baseline DNA and serum at key timepoints
    • Baseline, week 2, 4/8, 12/16, EOT (protocol or breakthrough/relapse), follow-up SVR (12 or 24)

Primary aims:

  • Safety and efficacy in populations represented and underrepresented in phase III clinical trials
    • African Americans, Hispanics
    • cirrhosis
    • null responders
    • age > 65
  • To refine point estimates and narrow confidence intervals for response to therapy
  • Current data precludes meaningful subgroup analyses to determine the cumulative influence of IL28B, fibrosis, viral subtype (1a vs 1b), other co-morbidities
  • Evaluate/inform FDA pharmacometric modeling
    • Unstudied populations
      • Boceprevir: Null responders indication
    • Unstudied dosing
      • Boceprevir: late responders duration of 32 weeks
      • Telaprevir: shorter therapy for prior relapse with eRVR
  • Virologic breakthrough and resistance
  • Impact of viral load measurement on treatment efficacy
    • Compliance and utility of current futility rules
    • Clinical relevance of “detectable / BLOQ” vs “undetectable”
  • Adverse event management and surveillance
  • Prediction of drug-drug interactions and mapping of off-target safety effects

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