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KMID : 1144320160480030219
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감염과 화학요법
2016 Volume.48 No. 3 p.219 ~ p.224
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Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in Asian Subjects with Human Immunodeficiency Virus 1 Infection: A Sub-Analysis of Phase 3 Clinical Trials
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Choi Jun-Yong
Sungkanuparph Somnuek
Anekthananon Thanomsak
Sax Paul
DeJesus Edwin
Edelstein Howard
Nelson Mark
DeMorin Jennifer
Liu Hui C.
Swamy Raji
Bahn Joonwoo
Hwang Sun-Jin
Yang Sang-Youn
Ng Christopher
Piontkowsky David
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Abstract
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The efficacy and safety of a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) were analyzed in Phase 3 clinical trials in antiretroviral therapy (ART)-naive and ART-experienced Asian subjects infected with human immunodeficiency virus (HIV)-1. Studies GS-US-236-102 and GS-US-236-103 were randomized, double-blind, placebo-controlled, 144-week studies conducted in ART-naive subjects, comparing E/C/F/TDF versus efavirenz (EFV)/F/TDF or ritonavir-boosted atazanavir (ATV+RTV) plus emtricitabine/tenofovir DF (F/TDF), respectively. Studies GS-US-236-115 and GS-US-236-121 were randomized, open-label, 96-week long conducted in ART-experienced subjects, who switched to E/C/F/TDF from ritonavir-boosted protease inhibitors (PI+RTV)+F/TDF, or non-nucleoside reverse transcriptase inhibitors (NNRTI)+F/TDF regimens. The E/C/F/TDF appeared to have sustained efficacy and safety and was well tolerated in the small number of ART-naive and ART-experienced Asian subjects.
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KEYWORD
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Human immunodeficiency virus, Antiretroviral therapy, Asian Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
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