• 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, and Andrew K Cheng.
• Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. jgallant@jhmi.edu
• J. Infect. Dis. 2013 Jul 1; 208 (1): 32-9.

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.

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