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.
- Author:
Jun Yong CHOI
1
;
Somnuek SUNGKANUPARPH
;
Thanomsak ANEKTHANANON
;
Paul SAX
;
Edwin DEJESUS
;
Howard EDELSTEIN
;
Mark NELSON
;
Jennifer DEMORIN
;
Hui C LIU
;
Raji SWAMY
;
Joonwoo BAHN
;
SunJin HWANG
;
Sang Youn YANG
;
Christopher NG
;
David PIONTKOWSKY
Author Information
- Publication Type:Randomized Controlled Trial ; Brief Communication
- Keywords: Human immunodeficiency virus; Antiretroviral therapy; Asian Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
- MeSH: Asian Continental Ancestry Group*; Atazanavir Sulfate; HIV*; HIV-1*; Humans; Humans*; Protease Inhibitors; Reverse Transcriptase Inhibitors
- From:Infection and Chemotherapy 2016;48(3):219-224
- CountryRepublic of Korea
- Language:English
- Abstract: 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)-naïve 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-naïve 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-naïve and ART-experienced Asian subjects.
