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


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

Webster’s Seventh New Collegiate Dictionary


Defining salvage
Defining Salvage: Patients: A Clinical Perspective

  • 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? Patients: A Clinical Perspective

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 Patients: A Clinical Perspective

  • 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 Patients: A Clinical Perspective

  • 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 Patients: A Clinical Perspective

  • 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 Patients: A Clinical Perspective

  • 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 Patients: A Clinical Perspective

  • 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 Patients: A Clinical Perspective

  • 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)


For patients in a salvage situation, a clinical trial is more than just an experiment: it is their treatment.


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