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

Research output: Contribution to journalArticle

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 + 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 (

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

Keywords

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

ASJC Scopus subject areas

  • Virology
  • Immunology

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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