Joel E Gallant1, Ellen Koenig, Jaime F Andrade-Villanueva, Ploenchan Chetchotisakd, Edwin DeJesus, Francisco Antunes, Keikawus Arastéh, Giuliano Rizzardini, Jan Fehr, Hui C Liu, Michael E Abram, Huyen Cao, Javier Szwarcberg. 1. *Southwest CARE Center, Santa Fe, NM; †Inst. Dominicano de Estudios Virologicos, Santo Domingo, Dominican Republic; ‡HIV Unit, Hospital Civil de Guadalajara, Guadalajara, Mexico; §Department of Medicine, Khonkaen University, Khonkaen, Thailand; ‖Orlando Immunology Center, Orlando, FL; ¶Instituto de Saúde Ambiental, Faculdade de Medicina de Lisboa, Lisbon, Portugal; #EPIMED, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany; **Infectious Diseases Department, "Luigi Sacco" Hospital, Milan, Italy; ††Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; and ‡‡Gilead Sciences, Inc., Foster City, CA.
Abstract
BACKGROUND:Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity. METHODS: International, randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir (RTV) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144. RESULTS: At Week 144, virologic suppression was achieved in 72% (COBI) and 74% (RTV) of patients. Adverse events leading to study drug discontinuation occurred in 11% of patients in each group. Median changes in serum creatinine (mg/dL) were +0.13 (COBI) and +0.07 (RTV) and were unchanged from week 48. CONCLUSIONS: Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor atazanavir.
RCT Entities:
BACKGROUND:Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity. METHODS: International, randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir (RTV) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144. RESULTS: At Week 144, virologic suppression was achieved in 72% (COBI) and 74% (RTV) of patients. Adverse events leading to study drug discontinuation occurred in 11% of patients in each group. Median changes in serum creatinine (mg/dL) were +0.13 (COBI) and +0.07 (RTV) and were unchanged from week 48. CONCLUSIONS: Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor atazanavir.
Authors: Joel Gallant; Graeme Moyle; Juan Berenguer; Peter Shalit; Huyen Cao; Ya-Pei Liu; Joel Myers; Lisa Rosenblatt; Lingfeng Yang; Javier Szwarcberg Journal: Curr HIV Res Date: 2017 Impact factor: 1.581