Efficacy and Safety of Atazanavirbased therapy in Antiretroviral Nave HIV SubjectsBMS 089

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Efficacy and Safety of Atazanavir-based therapy
in Antiretroviral Naïve HIV Subjects-BMS 089

• Background Efficacy and safety of ATZ boosted
  (300mg/100mg) or ATZ (400mg) with 3TC and d4T QD
  in naïve HIV patients.
• Methods 96 week randomized, open label trial.
  Primary endpoint was 400 copies/mL through week
  48. Secondary endpoints lt50 copies/mL and CD4.
  N 95 ATZ/r N 105 ATZ unboosted.
• Responders ATV/r 82(86) ATV 89(85)
• Median Baseline VL 4.83/5.02
• Median CD4 T-cell count 201/194

107LB-Malan
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Efficacy and Safety of Atazanavir-based therapy
in Antiretroviral Naïve HIV Subjects-BMS 089

• Results Week 48 ITT efficacy results were-
• HIV RNA 400 (86), 50 (75) - ATZ/r
• HIV RNA 400 (85), 50 (70) - ATZ
• Safety- All grade of jaundice and scleral icteris
  more common in the ATZ/r arm than ATZ arm
• ATZ/r had a higher rate of Grade 3-4
  hyperbilirubinemia
• Mean increase in triglycerides was 26 for ATZ/r
  
• Virologic failure greater in ATZ arm (10 vs 3)
• CD4 increases 189 ATZ vs. 224 ATZ/r arm
• Conclusions- Both doses of ATZ were equally
  efficacious, generally safe , and well
  tolerated, although ATZ/r had a higher rate of
  hyperbilirubinemia.

107LB-Malan
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Efficacy and Safety of Atazanavir-based therapy
in Antiretroviral Naïve HIV Subjects-BMS 089

• Limitiations Viral load stratification data was
  not shown.
• Clinical Utility
• Although ATV/r failures has no primary PI
  mutations and few NRTI mutations, safety concerns
  in the entire cohort were far greater
• Increases in triglycerides and cholesterol
• ALT elevations
• Liver abnormalities (sclera icterus,
  hyperbilirubinemia, jaundice)
• Starting with NFV vs ATZ eliminates concern for
  long term treatment planning and has a similar
  safety profile in terms of lipids, with better
  safety data for liver function.
• NFV is safe in pregnancy, so this is one less
  concern to worry about, as safety with ATZ in
  pregnancy is unknown.
• CD4 increases with NFV are comparable to boosted
  PIs.

106-LB-El Sadr
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