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

Jun Yong Choi, Somnuek Sungkanuparph, Thanomsak Anekthananon, Paul Sax, Edwin DeJesus, Howard Edelstein, Mark Nelson, Jennifer DeMorin, Hui C. Liu, Raji Swamy, Joonwoo Bahn, Sun Jin Hwang, Sang Youn Yang, Christopher Ng, David Piontkowsky

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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)-na�ve 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-na�ve 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-na�ve and ART-experienced Asian subjects.

Original languageEnglish
Pages (from-to)219-224
Number of pages6
JournalInfection and Chemotherapy
Volume48
Issue number3
DOIs
Publication statusPublished - 2016 Jan 1

All Science Journal Classification (ASJC) codes

  • Infectious Diseases
  • Pharmacology (medical)

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    Choi, J. Y., Sungkanuparph, S., Anekthananon, T., Sax, P., DeJesus, E., Edelstein, H., Nelson, M., DeMorin, J., Liu, H. C., Swamy, R., Bahn, J., Hwang, S. J., Yang, S. Y., Ng, C., & Piontkowsky, D. (2016). 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. Infection and Chemotherapy, 48(3), 219-224. https://doi.org/10.3947/ic.2016.48.3.219