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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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Antiviral drugs advisory committee may 13 2003

ANTIVIRAL DRUGS ADVISORY COMMITTEE

May 13, 2003

AtazanavirNDA 21- 567


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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