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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51650
Title: Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials
Authors: Yeon Sook Kim
Shinichi Oka
Ploenchan Chetchotisakd
Amanda Clarke
Khuanchai Supparatpinyo
Anchalee Avihingsanon
Winai Ratanasuwan
Sasisopin Kiertiburanakul
Kiat Ruxrungtham
Sang Youn Yang
Susan Guo
Ya Pei Liu
Moupali Das
Do Tran
Damian McColl
Roberto Corales
Chris Nguyen
David Piontkowsky
National Center for Global Health and Medicine
Chungnam National University
Khon Kaen University
The HIV Netherlands Australia Thailand Research Collaboration
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Faculty of Medicine, Siriraj Hospital, Mahidol University
Brighton and Sussex University Hospitals NHS Trust
Gilead Sciences Incorporated
Chiang Mai University
Thai Red Cross AIDS Research Centre
Keywords: Medicine
Issue Date: 4-May-2019
Citation: HIV Research and Clinical Practice. Vol.20, No.3 (2019), 73-81
Abstract: © 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. Background: The efficacy and safety of a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) was analyzed in Phase 3 clinical trials in antiretroviral therapy (ART)-naive and ART-experienced Asian participants infected with human immunodeficiency virus (HIV)-1 through 96 or 144 weeks. Objective: In Asian population requiring treatment, it is imperative to have data specific to this group, particularly as there is a general concern that Asians with lower body weight have increased risk of tenofovir disoproxil fumarate (TDF)-related renal dysfunction. Methods: Studies -104 and 111 were randomized, double-blind, placebo-controlled, 144-week studies conducted in ART-naive participants, comparing E/C/F/TAF versus E/C/F/TDF. Study 109 was a randomized, open-label, 96-week study conducted in virologically suppressed, ART-experienced participants, who switched to E/C/F/TAF from ritonavir/cobicistat-boosted atazanavir ATV+(RTV or COBI) + F/TDF regimens, from non-nucleoside reverse transcriptase inhibitors (NNRTI) + F/TDF regimens, or from E/C/F/TDF. Study 112 was a single arm, open-label, 144-week study conducted in HIV suppressed, ART-experienced participants with mild-moderate renal impairment, who switched to E/C/F/TAF. Results: Asian participants in these studies had sustained efficacy safety and tolerability. In Study 104/111, Asian participants achieved 93% virologic suppression on TAF vs 88% on TDF at week 144. At baseline, there were numerically more Asians with median CD4 counts < 200 cells/uL and VL > 100,000 c/mL. In Study 109, 95% of Asians on TAF vs 86% on TDF maintained virologic suppression at week 96. Lastly, in Study 112, 91% maintained virologic suppression at week 144. There were no discontinuations due to renal AE, no cases of PRT or Fanconi syndrome in any of the studies.
URI: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51650
metadata.dc.identifier.url: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85076381646&origin=inward
ISSN: 25787470
25787489
Appears in Collections:Scopus 2019

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