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.

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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.

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Journal

Journal ID (iso-abbrev): Lancet HIV

Title: The lancet. HIV

Publisher: Elsevier BV

ISSN (Electronic): 2352-3018

ISSN (Print): 2352-3018

Publication date (Electronic): Apr 2016

Volume: 3

Issue: 4

Affiliations

[1 ] Southwest CARE Center, Santa Fe, NM, USA.

[2 ] Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.

[3 ] CMIT, Paris, France.

[4 ] Central Texas Clinical Research, Austin, TX, USA.

[5 ] Peter J Ruane MD Inc, Los Angeles, CA, USA.

[6 ] Orlando Immunology Center, Orlando, FL, USA.

[7 ] Royal Free London NHS Foundation Trust, London, UK.

[8 ] CHU Saint-Pierre University Hospital, Brussels, Belgium.

[9 ] Triple O Research Institute PA, FL, USA.

[10 ] Dupont Circle Physicians Group, Washington, DC, USA.

[11 ] Clinical Research Puerto Rico Inc San Juan, Puerto Rico.

[12 ] Gilead Sciences, Foster City, CA, USA.

[13 ] Gilead Sciences, Foster City, CA, USA. Electronic address: martin.rhee@gilead.com.

Article

Publisher Item ID: S2352-3018(16)00024-2

DOI: 10.1016/S2352-3018(16)00024-2

PubMed ID: 27036991

SO-VID: 771f130a-e007-428a-a864-72233f207234

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