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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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, Volume 208, No. 1, Year 2013
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Description
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 <50 copies/mL at week 48 by the Food and Drug Administration snapshot algorithm; the noninferiority margin was 12%.Results. A total of 692 patients were randomly assigned to a treatment arm and received study drug (344 in the COBI group vs 348 in the RTV group). At week 48, virologic success was achieved in 85% of COBI recipients and 87% of RTV recipients (difference, -2.2% [95% confidence interval, -7.4% to 3.0%]); among patients with a baseline 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. © 2013 The Author 2013.
Authors & Co-Authors
Gallant, Joel E.
United States, Baltimore
Johns Hopkins University
Koenig, Ellen
Unknown Affiliation
Andrade-Villanueva, Jaime Federico
Mexico, Guadalajara
Hospital Civil de Guadalajara
Chetchotisakd, Ploenchan
Unknown Affiliation
DeJesus, Edwin
United States, Orlando
Orlando Immunology Center
Antúnes, Francisco
Portugal, Lisbon
Santa Maria Hospital, Lisbon
Arastéh, Keikawus N.
Germany, Berlin
Vivantes Auguste-viktoria-klinikum
Moyle, Graeme J.
United Kingdom, London
Chelsea and Westminster Hospital
Rizzardini, Giuliano
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Fehr, Jan Sven
Switzerland, Zurich
Universität Zürich
Liu, Yapei
United States, Foster City
Gilead Sciences Incorporated
Zhong, Lijie
United States, Foster City
Gilead Sciences Incorporated
Callebaut, Christian
United States, Foster City
Gilead Sciences Incorporated
Szwarcberg, Javier
United States, Foster City
Gilead Sciences Incorporated
Rhee, Martin S.
United States, Foster City
Gilead Sciences Incorporated
Cheng, Andrew K.
United States, Foster City
Gilead Sciences Incorporated
Statistics
Citations: 118
Authors: 16
Affiliations: 9
Identifiers
Doi:
10.1093/infdis/jit122
ISSN:
00221899
Research Areas
Disability
Food Security
Infectious Diseases