Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV

Kathleen Squires, Adriano Lazzarin, José M. Gatell, William G. Powderly, Vadim Pokrovskiy, Jean François Delfraissy, Joseph Jemsek, Antonio Rivero, Willy Rozenbaum, Shannon Schrader, Michael Sension, Asda Vibhagool, Alexandra Thiry, Michael Giordano

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278 Scopus citations

Abstract

Background: Atazanavir, an azapeptide protease inhibitor (PI), has pharmacokinetics that allow once-daily dosing, and it is not associated with significant PI-associated dyslipidemia. Methods: A randomized, double-blind, double-dummy, active-controlled, 2-arm study comparing the antiviral efficacy and safety of atazanavir 400 mg administered once daily with efavirenz 600 mg administered once daily in combination with open-label fixed-dose zidovudine plus lamivudine twice daily. The 810 treatment-naive patients were stratified by HIV RNA level. The primary efficacy end point was the proportion of treated patients with HIV RNA levels <400 copies/mL through week 48. Results: At week 48, HIV RNA levels were <400 copies/mL in 70% of patients receiving atazanavir and 64% of patients receiving efavirenz (intent-to-treat, difference; 95% confidence interval: 5.2%; -1.2%, 11.7%). Median CD4+ cell counts increased at comparable magnitudes and rates in the 2 treatment arms (mean change at week 48: 176 cells/mm3 with atazanavir, 160 cells/mm3 with efavirenz). Atazanavir-treated patients relative to comparator-treated patients did not demonstrate significant increases in total cholesterol, fasting low-density lipoprotein cholesterol, or fasting triglycerides over 48 weeks of therapy. Atazanavir-linked bilirubin elevations infrequently resulted in treatment discontinuation (<1%). Atazanavir treatment did not increase fasting glucose or insulin levels. Conclusions: For initial HIV treatment, a highly active antiretroviral therapy regimen of atazanavir/zidovudine/lamivudine is as efficacious and well tolerated as the combination of efavirenz/zidovudine/lamivudine.

Original languageEnglish
Pages (from-to)1011-1019
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Volume36
Issue number5
DOIs
StatePublished - Aug 15 2004

Keywords

  • Atazanavir
  • Efavirenz
  • HIV
  • Highly active antiretroviral therapy
  • Lipids
  • Protease inhibitors

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    Squires, K., Lazzarin, A., Gatell, J. M., Powderly, W. G., Pokrovskiy, V., Delfraissy, J. F., Jemsek, J., Rivero, A., Rozenbaum, W., Schrader, S., Sension, M., Vibhagool, A., Thiry, A., & Giordano, M. (2004). Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. Journal of Acquired Immune Deficiency Syndromes, 36(5), 1011-1019. https://doi.org/10.1097/00126334-200408150-00003