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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 monitoring to increase the efficiency and quality of an observational registry while also minimizing costs typically associated with performing post-marketing clinical research.
  • HCV-TARGET hosts REDCap databases that are CFR 21 Part 11 compliant and includes MEDRA adverse event and WHO drug dictionary coding standardization.
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, 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
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
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
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 Ph III clinical trials
  • To identify educational gaps relative to treatment guidelines and management of adverse events
  • To develop a core for translational studies
  • To implement a rapid clinical trials network for novel studies

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