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

• Published in: Infection & chemotherapy Vol. 48; no. 3; pp. 219 - 224
• Main Authors: 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, SunJin, Yang, Sang Youn, Ng, Christopher, Piontkowsky, David
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society of Infectious Diseases and Korean Society for Chemotherapy 01.09.2016; 대한감염학회
• Subjects: Brief Communication; 내과학; Asian Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; Antiretroviral therapy; Human immunodeficiency virus
• ISSN: 2093-2340; 2092-6448
• DOI: 10.3947/ic.2016.48.3.219

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.