title: 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.
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.
authors.affiliation: Department of Internal Medicine, Severance Hospital, Yonsei University, College of Medicine, Seoul, Korea. seran@yuhs.ac.
authors.forename: Jun Yong
authors.identifier: http://orcid.org/0000-0002-2775-3315
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Somnuek
authors.initials: S
authors.lastname: Sungkanuparph
authors.affiliation: Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Thanomsak
authors.initials: T
authors.lastname: Anekthananon
authors.affiliation: Brigham and Women's Hospital. Boston, MA, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Sax
authors.affiliation: Orlando Immunology Center, Orlando, FL, USA.
authors.forename: Edwin
authors.initials: E
authors.lastname: DeJesus
authors.affiliation: Highland General Hospital, Oakland, CA, USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Edelstein
authors.affiliation: Chelsea and Westminster Hospital, London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.affiliation: Gilead Sciences, Inc Foster City, CA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: DeMorin
authors.affiliation: Gilead Sciences, Inc Foster City, CA, USA.
authors.forename: Hui C
authors.initials: HC
authors.lastname: Liu
authors.affiliation: Gilead Sciences, Inc Foster City, CA, USA.
authors.forename: Raji
authors.initials: R
authors.lastname: Swamy
authors.affiliation: Gilead Sciences Korea Ltd, Seoul, Korea.
authors.forename: Joonwoo
authors.initials: J
authors.lastname: Bahn
authors.affiliation: Gilead Sciences Korea Ltd, Seoul, Korea.
authors.forename: Sunjin
authors.initials: S
authors.lastname: Hwang
authors.affiliation: Gilead Sciences Korea Ltd, Seoul, Korea.
authors.forename: Sang Youn
authors.initials: SY
authors.lastname: Yang
authors.affiliation: Gilead Sciences, Inc Foster City, CA, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Ng
authors.affiliation: Gilead Sciences, Inc Foster City, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Piontkowsky
keywords: Antiretroviral therapy; Asian Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; Human immunodeficiency virus