Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: Week 48 results

Joel E. Gallant, Ellen Koenig, Jaime Andrade-Villanueva, Ploenchan Chetchotisakd, Edwin Dejesus, Francisco Antunes, Keikawus Arastéh, Graeme Moyle, Giuliano Rizzardini, Jan Fehr, Yapei Liu, Lijie Zhong, Christian Callebaut, Javier Szwarcberg, Martin S. Rhee, Andrew K. Cheng

Research output: Contribution to journalArticle

Abstract

Background. Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity in vitro.Methods. An international, randomized, double-blind, double-dummy, active-controlled trial was conducted to evaluate the efficacy and safety of COBI versus ritonavir (RTV) as a pharmacoenhancer of atazanavir (ATV) in combination with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in treatment-naive patients. The primary end point was a human immunodeficiency virus type 1 (HIV-1) RNA load of 100 000 copies/mL, rates were similar (86% vs 86%). Similar percentages of patients in both groups had serious adverse events (10% of COBI recipients vs 7% of RTV recipients) and adverse events leading to discontinuation of treatment with the study drug (7% vs 7%). Median increases in the serum creatinine level were 0.13 and 0.09 mg/dL, respectively, for COBI and RTV recipients.Conclusions. COBI was noninferior to RTV in combination with ATV plus FTC/TDF at week 48. Both regimens achieved high rates of virologic success. Safety and tolerability profiles of the 2 regimens were comparable. Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor ATV.Clinical Trials Registration. NCT01108510.

Original languageEnglish (US)
Pages (from-to)32-39
Number of pages8
JournalJournal of Infectious Diseases
Volume208
Issue number1
DOIs
StatePublished - Jul 1 2013

Keywords

  • cobicistat
  • HIV
  • pharmacoenhancer

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

Fingerprint Dive into the research topics of 'Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: Week 48 results'. Together they form a unique fingerprint.

  • Cite this

    Gallant, J. E., Koenig, E., Andrade-Villanueva, J., Chetchotisakd, P., Dejesus, E., Antunes, F., Arastéh, K., Moyle, G., Rizzardini, G., Fehr, J., Liu, Y., Zhong, L., Callebaut, C., Szwarcberg, J., Rhee, M. S., & Cheng, A. K. (2013). Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: Week 48 results. Journal of Infectious Diseases, 208(1), 32-39. https://doi.org/10.1093/infdis/jit122