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
Journal article published in 2016 by
Joel E. Gallant,
Eric S. Daar,
François Raffi,
Cynthia Brinson,
Peter Ruane,
Edwin DeJesus,
Margaret Johnson,
Nathan Clumeck,
Olayemi Osiyemi,
Doug Ward,
Javier Morales-Ramirez,
Mingjin Yan,
Michael E. Abram 
,
Andrew Plummer,
Andrew K. Cheng
and other authors.
,
Andrew Plummer,
Andrew K. Cheng
and other authors.
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Abstract
Emtricitabine with tenofovir disoproxil fumarate is a standard-of-care nucleoside reverse transcriptase inhibitor (NRTI) backbone. However, tenofovir disoproxil fumarate is associated with renal and bone toxic effects; the novel prodrug tenofovir alafenamide achieves 90% lower plasma tenofovir concentrations. We aimed to further assess safety and efficacy of fixed-dose combination emtricitabine with tenofovir alafenamide in patients switched from emtricitabine with tenofovir disoproxil fumarate.