antiviral drugs advisory committee may 13 2003
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ANTIVIRAL DRUGS ADVISORY COMMITTEE May 13, 2003. Atazanavir NDA 21- 567. Protease Inhibitors for HIV Treatment. Six marketed protease inhibitors SQV, RTV, IDV, NFV, APV, LPV/RTV Class effects include: lipid elevations lipodystrophy diabetes/hyperglycemia.

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Presentation Transcript
protease inhibitors for hiv treatment
Protease Inhibitors for HIV Treatment
  • Six marketed protease inhibitors
    • SQV, RTV, IDV, NFV, APV, LPV/RTV
  • Class effects include:
    • lipid elevations
    • lipodystrophy
    • diabetes/hyperglycemia
atazanavir vs other pis similarities and potential differences
Atazanavir vs Other PIs: Similarities and Potential Differences
  • Class effects
    • Treatment with atazanavir resulted in less of an increase in lipid parameters compared to nelfinivir in phase 2 studies
    • Findings confirmed in phase 3 studies
    • Lipodystrophy/diabetes seen in atazanavir clinical trials
atazanavir vs other pis similarities and potential differences1
Atazanavir vs Other PIs: Similarities and Potential Differences
  • Hyperbilirubinemia (indirect)
    • UGT 1A1 inhibition
      • Similar mechanism to IDV
      • Incidence > 75% Grades 1- 4
        • Grade 3- 4 T.bilirubin 40%
        • Incidence with IDV about 10%
  • QT/PR prolongation
  • Resistance Profile
atazanavir for hiv treatment
Atazanavir for HIV Treatment
  • 2 principal studies
    • 034 - naïve (n=810) - 48 wk data
    • 043 - treatment experienced (n= 300)
  • 045 - highly treatment experienced

RTV boosted regimen

only 16 week data submitted

reviewed for safety only

  • Phase 2 trials - 007 and 008 (48 + wk data)
advisory committee issues
Advisory Committee Issues
  • Safety and efficacy of atazanavir
    • hyperbilirubinemia
    • QT/PR prolongation
    • lipid effects
  • Results in treatment experienced population
  • Resistance assessment
advisory committee agenda
Advisory Committee Agenda

8:15 a.m. Opening remarks

8:30 a.m. Evaluation of QT interval

8:45 a.m. BMS Presentation

10:00 a.m. Clarifying Questions

10:15 a.m. Break

10:30 a.m. FDA Presentation

  • Kendall A. Marcus, M.D.
  • Thomas Hammerstrom, Ph.D.
  • Lisa K. Naeger, Ph.D.

11:30 a.m. Questions

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

2:00 p.m. Charge and Questions to the Committee

5:00 p.m. Adjourn

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