1 / 13

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.

miyoko
Télécharger la présentation

Therapeutic Challenges for Antiretroviral Experienced Patients: A Clinical Perspective

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related