Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically Suppressed Women.

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Sally HodderHuyen Cao

Abstract

The integrase inhibitor regimen [elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (TDF)] demonstrated superior efficacy when compared with a protease inhibitor regimen [ritonavir-boosted atazanavir (ATV + RTV) and FTC/TDF] in 575 treatment-naive women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing elvitegravir, cobicistat, FTC, and tenofovir alafenamide (E/C/F/TAF) versus remaining on ATV + RTV plus FTC/TDF. After completing the initial randomized, blinded phase, virologically suppressed (HIV-1 RNA <50 copies/mL) women on ATV + RTV plus FTC/TDF were rerandomized (3:1) to receive open-label E/C/F/TAF versus remaining on their current regimen. The primary end point was proportion of participants with plasma HIV-1 RNA <50 copies per milliliter at week 48 (U.S. FDA snapshot algorithm), with a prespecified noninferiority margin of 12%. Safety [adverse events (AEs)] and tolerability were also assessed. Of 575 women originally randomized and treated in the blinded phase, 159 were rerandomized to switch to E/C/F/TAF and 53 to remain on ATV + RTV plus FTC/TDF. At week 48, virologic suppression was maintained in 150 (94%) of women on E/C/...Continue Reading

References

Dec 28, 2007·The Journal of Clinical Endocrinology and Metabolism·Joel S FinkelsteinRobert M Neer
Apr 14, 2009·AIDS Research and Human Retroviruses·Ei Kinai, Hideji Hanabusa
Mar 26, 2011·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Andrew M HallJohn O Connolly
Jun 29, 2013·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Peter J RuaneKitty Yale
Sep 23, 2014·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Gregory M LucasUNKNOWN HIV Medicine Association of the Infectious Diseases Society of America
Apr 15, 2015·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·José R SantosUNKNOWN Tenofovir/emtricitabine inflUence on LIPid metabolism (TULIP) Study Group
Jul 13, 2016·JAMA : the Journal of the American Medical Association·Huldrych F GünthardPaul A Volberding

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Citations

Dec 5, 2018·Expert Review of Clinical Pharmacology·Giovanni Di PerriStefano Bonora
Dec 15, 2020·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Ignacio Perez-ValeroRichard Haubrich

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