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Volumn 3, Issue 4, 2016, Pages e158-e165

Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial

(16)  Gallant, Joel E a   Daar, Eric S b   Raffi, François c   Brinson, Cynthia d   Ruane, Peter e   DeJesus, Edwin f   Johnson, Margaret g   Clumeck, Nathan h   Osiyemi, Olayemi i   Ward, Doug j   Morales Ramirez, Javier k   Yan, Mingjin l   Abram, Michael E l   Plummer, Andrew l   Cheng, Andrew K l   Rhee, Martin S l  

c CMIT   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ATAZANAVIR; BETA 2 MICROGLOBULIN; CREATININE; DARUNAVIR; EMTRICITABINE; LOPINAVIR; RETINOL BINDING PROTEIN; TENOFOVIR ALAFENAMIDE; TENOFOVIR DISOPROXIL; VIRUS RNA; ADENINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTIVIRUS AGENT; GS-7340; TENOFOVIR;

EID: 84960824872     PISSN: None     EISSN: 23523018     Source Type: Journal    
DOI: 10.1016/S2352-3018(16)00024-2     Document Type: Article
Times cited : (151)

References (20)
  • 1
    • 84964370520 scopus 로고    scopus 로고
    • Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents
    • (accessed Jan 25, 2015).
    • 1 Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf, 2015 (accessed Jan 25, 2015).
    • (2015)
  • 2
    • 84977649754 scopus 로고    scopus 로고
    • Viread (tenofovir disoproxil fumarate) package insert
    • (accessed Nov 1, 2015).
    • 2 Gilead Sciences. Viread (tenofovir disoproxil fumarate) package insert. http://www.gilead.com/∼/media/files/pdfs/medicines/hiv/viread/viread_pi.pdf?la=en (accessed Nov 1, 2015).
  • 3
    • 79957494036 scopus 로고    scopus 로고
    • Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202
    • 3 McComsey, GA, Kitch, D, Daar, ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis 203 (2011), 1791–1801.
    • (2011) J Infect Dis , vol.203 , pp. 1791-1801
    • McComsey, G.A.1    Kitch, D.2    Daar, E.S.3
  • 4
    • 84898478011 scopus 로고    scopus 로고
    • Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults
    • 4 Markowitz, M, Zolopa, A, Squires, K, et al. Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults. J Antimicrob Chemother 69 (2014), 1362–1369.
    • (2014) J Antimicrob Chemother , vol.69 , pp. 1362-1369
    • Markowitz, M.1    Zolopa, A.2    Squires, K.3
  • 5
    • 84880229518 scopus 로고    scopus 로고
    • Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults
    • 5 Ruane, PJ, DeJesus, E, Berger, D, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. J Acquir Immune Defic Syndr 63 (2013), 449–455.
    • (2013) J Acquir Immune Defic Syndr , vol.63 , pp. 449-455
    • Ruane, P.J.1    DeJesus, E.2    Berger, D.3
  • 6
    • 84937215233 scopus 로고    scopus 로고
    • Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials
    • 6 Sax, PE, Wohl, D, Yin, MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet 385 (2015), 2606–2615.
    • (2015) Lancet , vol.385 , pp. 2606-2615
    • Sax, P.E.1    Wohl, D.2    Yin, M.T.3
  • 7
    • 84906080271 scopus 로고    scopus 로고
    • Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study
    • 7 Sax, PE, Zolopa, A, Brar, I, et al. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr 67 (2014), 52–58.
    • (2014) J Acquir Immune Defic Syndr , vol.67 , pp. 52-58
    • Sax, P.E.1    Zolopa, A.2    Brar, I.3
  • 8
    • 84937531121 scopus 로고    scopus 로고
    • Tenofovir alafenamide versus tenofovir disoproxil fumarate in the first protease inhibitor-based single-tablet regimen for initial HIV-1 therapy: a randomized phase 2 study
    • 8 Mills, A, Crofoot, G Jr, McDonald, C, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate in the first protease inhibitor-based single-tablet regimen for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr 69 (2015), 439–445.
    • (2015) J Acquir Immune Defic Syndr , vol.69 , pp. 439-445
    • Mills, A.1    Crofoot, G.2    McDonald, C.3
  • 9
    • 55249115137 scopus 로고    scopus 로고
    • The 3-year renal safety of a tenofovir disoproxil fumarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients
    • 9 Gallant, JE, Winston, JA, DeJesus, E, et al. The 3-year renal safety of a tenofovir disoproxil fumarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients. AIDS 22 (2008), 2155–2163.
    • (2008) AIDS , vol.22 , pp. 2155-2163
    • Gallant, J.E.1    Winston, J.A.2    DeJesus, E.3
  • 10
    • 84894503546 scopus 로고    scopus 로고
    • A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results
    • 10 Wohl, DA, Cohen, C, Gallant, JE, et al. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr 65 (2014), e118–e120.
    • (2014) J Acquir Immune Defic Syndr , vol.65 , pp. e118-e120
    • Wohl, D.A.1    Cohen, C.2    Gallant, J.E.3
  • 11
    • 84894424714 scopus 로고    scopus 로고
    • A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results
    • 11 Clumeck, N, Molina, JM, Henry, K, et al. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr 65 (2014), e121–e124.
    • (2014) J Acquir Immune Defic Syndr , vol.65 , pp. e121-e124
    • Clumeck, N.1    Molina, J.M.2    Henry, K.3
  • 12
    • 84933051378 scopus 로고    scopus 로고
    • Brief report: cobicistat compared with ritonavir as a pharmacoenhancer for atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate: week 144 results
    • 12 Gallant, JE, Koenig, E, Andrade-Villanueva, JF, et al. Brief report: cobicistat compared with ritonavir as a pharmacoenhancer for atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate: week 144 results. J Acquir Immune Defic Syndr 69 (2015), 338–340.
    • (2015) J Acquir Immune Defic Syndr , vol.69 , pp. 338-340
    • Gallant, J.E.1    Koenig, E.2    Andrade-Villanueva, J.F.3
  • 13
    • 84996874076 scopus 로고    scopus 로고
    • European Guidelines for treatment of HIV-infected adults in Europe 8.0
    • (accessed Jan 25, 2016).
    • 13 European AIDS Clinical Society. European Guidelines for treatment of HIV-infected adults in Europe 8.0. http://www.eacsociety.org/files/2015_eacsguidelines_8.0-english_rev-20151221.pdf, 2015 (accessed Jan 25, 2016).
    • (2015)
  • 14
    • 85028245571 scopus 로고    scopus 로고
    • Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study
    • 14 Mills, A, Arribas, JR, Andrade-Villanueva, J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis 16 (2016), 43–52.
    • (2016) Lancet Infect Dis , vol.16 , pp. 43-52
    • Mills, A.1    Arribas, J.R.2    Andrade-Villanueva, J.3
  • 15
    • 84865714929 scopus 로고    scopus 로고
    • Effect of cobicistat on glomerular filtration rate in subjects with normal and impaired renal function
    • 15 German, P, Liu, HC, Szwarcberg, J, et al. Effect of cobicistat on glomerular filtration rate in subjects with normal and impaired renal function. J Acquir Immune Defic Syndr 61 (2012), 32–40.
    • (2012) J Acquir Immune Defic Syndr , vol.61 , pp. 32-40
    • German, P.1    Liu, H.C.2    Szwarcberg, J.3
  • 16
    • 33749531758 scopus 로고    scopus 로고
    • Mechanism of active renal tubular efflux of tenofovir
    • 16 Ray, AS, Cihlar, T, Robinson, KL, et al. Mechanism of active renal tubular efflux of tenofovir. Antimicrob Agents Chemother 50 (2006), 3297–3304.
    • (2006) Antimicrob Agents Chemother , vol.50 , pp. 3297-3304
    • Ray, A.S.1    Cihlar, T.2    Robinson, K.L.3
  • 17
    • 84977656926 scopus 로고    scopus 로고
    • Safety of tenofovir alafenamide in renal impairment [Abstract 795]
    • Conference on Retroviruses and Opportunistic Infections; Seattle, WA, USA; Feb 23–26
    • 17 Pozniak A, Arribas J, Gupta SK, et al. Safety of tenofovir alafenamide in renal impairment [Abstract 795]. Conference on Retroviruses and Opportunistic Infections; Seattle, WA, USA; Feb 23–26, 2015.
    • (2015)
    • Pozniak, A.1    Arribas, J.2    Gupta, S.K.3
  • 18
    • 84937216962 scopus 로고    scopus 로고
    • Tenofovir alafenamide for HIV infection: is less more?
    • 18 Wyatt, C, Baeten, JM, Tenofovir alafenamide for HIV infection: is less more?. Lancet 385 (2015), 2559–2560.
    • (2015) Lancet , vol.385 , pp. 2559-2560
    • Wyatt, C.1    Baeten, J.M.2
  • 19
    • 77954319572 scopus 로고    scopus 로고
    • A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable background antiretroviral therapy: ACTG 5206
    • 19 Tungsiripat, M, Kitch, D, Glesby, MJ, et al. A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable background antiretroviral therapy: ACTG 5206. AIDS 24 (2010), 1781–1784.
    • (2010) AIDS , vol.24 , pp. 1781-1784
    • Tungsiripat, M.1    Kitch, D.2    Glesby, M.J.3
  • 20
    • 84977668925 scopus 로고    scopus 로고
    • Integrated analysis of emergent drug resistance through 48 weeks from clinical studies of HIV-1 treatment-naive subjects receiving E/C/F/TAF
    • XXIV International HIV Drug Resistance Workshop; Seattle, WA, USA; Feb 21–22;. 6
    • 20 Margot N, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Integrated analysis of emergent drug resistance through 48 weeks from clinical studies of HIV-1 treatment-naive subjects receiving E/C/F/TAF. XXIV International HIV Drug Resistance Workshop; Seattle, WA, USA; Feb 21–22; 2015. 6.
    • (2015)
    • Margot, N.1    Kitrinos, K.M.2    Fordyce, M.3    McCallister, S.4    Miller, M.D.5    Callebaut, C.6


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