Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures

Margaret Johnson, Beatriz Grinsztejn, Claudia Rodriguez, Jeffrey Coco, Edwin DeJesus, Adriano Lazzarin, Kenneth Lichtenstein, Anna Rightmire, Serap Sankoh, Richard Wilber

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate atazanavir/ritonavir (ATV/RTV) (300/100 mg) once daily, atazanavir/saquinavir (ATV/SQV) (400/1200mg) once daily, and lopinavir/ritonavir (LPV/RTV) (400/100 mg) twice daily, each with tenofovir (300 mg) once daily and a nucleoside reverse transcriptase inhibitor in treatment-experienced HIV-infected patients: Methods: Randomized, open-label, 48-week multicenter trial of 358 randomized adult patients who had failed two or more prior HAART regimens with baseline HIV RNA ≥ 1000 copies/ml and CD4 cell count ≥ 50 × 106 cells/l. Results: The primary efficacy endpoint [plasma HIV RNA reduction assessed by time-averaged difference (TAD)] was similar for ATV/RTV and LPV/RTV [TAD 0.13; 97.5% confidence interval, -0.12 to 0.39] at 48 weeks. Mean reductions from baseline for ATV/RTV and LPV/RTV were comparable at 1.93 and 1.87 log10 copies/ml, respectively. Mean CD4 cell count increases were 110 and 121 × 106 cells/l for ATV/RTV, and LPV/RTV, respectively. The efficacy of ATV/SQV was lower than LPV/RTV by both these parameters. Declines in total cholesterol and fasting triglycerides were greater with ATV/RTV and ATV/SQV than with LPV/RTV (P ≤ 0.005). Lipids in the LPV/RTV arm at week 48 generally increased from baseline. Lipid-lowering agents were used more frequently in the LPV/RTV arm than in the ATV arms (P <0.05 versus ATV/RTV), as were antidiarrheal agents (P <0.04 versus both AW treatments). No new or unique safety findings emerged. Conclusions: ATV boosted with RTV is as effective and well tolerated as LPV/RTV in treatment-experienced patients, with a more favorable impact on serum lipids. Pharmacokinetically enhanced ATV provides a suitable choice for therapy of treatment-experienced HIV-infected patients.

Original languageEnglish
Pages (from-to)685-694
Number of pages10
JournalAIDS (London, England)
Volume19
Issue number7
Publication statusPublished - Apr 29 2005

Keywords

  • Antiretroviral therapy
  • Atazanavir
  • Iopinavir
  • Lipids
  • Protease inhibitors
  • Ritonavir
  • Saquinavir

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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