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Atazanavir NDA 21- 567

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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Atazanavir NDA 21- 567

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  1. ANTIVIRAL DRUGS ADVISORY COMMITTEE May 13, 2003 AtazanavirNDA 21- 567

  2. Protease Inhibitors for HIV Treatment • Six marketed protease inhibitors • SQV, RTV, IDV, NFV, APV, LPV/RTV • Class effects include: • lipid elevations • lipodystrophy • diabetes/hyperglycemia

  3. 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

  4. 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

  5. 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)

  6. Advisory Committee Issues • Safety and efficacy of atazanavir • hyperbilirubinemia • QT/PR prolongation • lipid effects • Results in treatment experienced population • Resistance assessment

  7. 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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