therapeutic challenges for antiretroviral experienced patients a clinical perspective
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Therapeutic Challenges for Antiretroviral Experienced Patients: A Clinical Perspective. Douglas J. Ward, MD Washington, DC. sal.vage ‘sal-vij vt [F, fr, MF fr. Salver to save – more at SAVE]: to rescue or save (as from wreckage or ruin)…. Webster’s Seventh New Collegiate Dictionary.

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therapeutic challenges for antiretroviral experienced patients a clinical perspective

Therapeutic Challenges for Antiretroviral Experienced Patients: A Clinical Perspective

Douglas J. Ward, MD

Washington, DC

slide2
sal.vage \ ‘sal-vij\ vt [F, fr, MF fr. Salver to save – more at SAVE]: to rescue or save (as from wreckage or ruin)…

Webster’s Seventh New Collegiate Dictionary

defining salvage
Defining Salvage:
  • Treatment failure based on treatment history
    • At least two HAART regimens that have included at least one drug from each approved class
    • What viral load is failure?
  • Based on genotypic / phenotypic resistance
who needs salvage therapy
Who needs salvage therapy?

With currently available therapies successful treatment of a naïve patient should be easy.

Treatment failures:

  • Prolonged RT monotherapy before HAART
  • Noncompliance
  • Poor treatment choice
  • Other
prevalence of treatment failure
Prevalence of treatment failure
  • 5 – 60% in clinical trials
  • Higher in surveys of clinical practice
  • Lower in subsequent regimens
    • Resistance to drugs in original regimen persists
dcpg distribution of patients
DCPG: Distribution of Patients
  • No treatment: 54 19%
  • BLQ on first regimen 74 26%
  • BLQ since HAART 77 27%
  • BLQ on salvage 33 12%
  • Not BLQ (needs salvage) 34 12%
  • Other 11 4%
problems with salvage
Problems with Salvage
  • Cross-resistance with previous drugs
  • Multi-drug regimens (MegaHAART) difficult to tolerate
  • New agents usually available one at a time
    • Exception, 1998: efavirenz, abacavir, adefovir
    • DCPG: >100 patients enrolled
problems with salvage trials
Problems with Salvage Trials
  • Diverse patient population (treatment history, resistance)
  • New agent trials designed for licensing: difficult to show efficacy in salvage situation
    • DCPG 2000-2001 trials offered:
    • 8 for “naïves”
    • 2 “experienced” but restrictive (e.g: first PI failure, NNRTI naïve)
    • 2 salvage: tenofovir expanded access, PEG-interferon
salvage trials what the clinician wants
Salvage Trials: What the Clinician Wants
  • Reasonable expectation of efficacy (new agents, or comparison of regimens with existing regimens)
  • Salvage trials for new agents available before target population experienced (expanded access)
  • Entry criteria for the populations at need
  • Flexible criteria for “success”, but bail out for lack of effect
  • Placebo controls acceptable if efficacy of agent truly unknown
  • Inclusion of non-drug interventions (STI’s, immune stimulants, etc.)
salvage trials what patients want
Salvage Trials: What Patients Want
  • Reasonable expectation of efficacy
  • Desperation: access to new agents asap (but optimally not as monotherapy)
    • Willing to wait if stable
  • ? Willing to accept more risk of toxicity (? but more prone to toxicity)
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For patients in a salvage situation, a clinical trial is more than just an experiment: it is their treatment.
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