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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. 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

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  1. Therapeutic Challenges for Antiretroviral Experienced Patients: A Clinical Perspective Douglas J. Ward, MD Washington, DC

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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%

  7. 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

  8. 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

  9. 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.)

  10. 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)

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

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