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J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.

Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.

Author information

1
*Infectious Diseases Unit, Internal Medicine Service, Hospital Universitario La Paz, Madrid, ES; †AIDS Research Consortium of Atlanta, Atlanta, GA; ‡Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA; §Internal Medicine, General Hospital Graz-West, Graz, AT; ‖Tarrant County Infectious Disease Associates, Fort Worth, TX; ¶Division of Infectious Diseases, UNC School of Medicine, Chapel Hill, NC; #Orlando Immunology Center, Orlando, FL; **Claude Nicol Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom; and ††Departments of Biometrics, Virology, Clinical Operations, and HIV Clinical Research, Gilead Sciences, Inc., Foster City, CA.

Abstract

In 2 double-blind phase 3 trials, 1733 antiretroviral-naive adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs 80.0% having HIV-1 RNA <50 copies/mL (difference 4.2%; 95% confidence interval: 0.6% to 7.8%). TAF had less impact than TDF on bone mineral density and renal biomarkers. No participants on TAF had renal-related discontinuations vs 12 on TDF (P < 0.001), with no cases of proximal tubulopathy for TAF vs 4 for TDF. There were greater increases in lipids with TAF vs TDF, with no difference in the total cholesterol to high-density lipoprotein ratio. For initial HIV therapy, E/C/F/TAF is superior to E/C/F/TDF in efficacy and bone and renal safety.

PMID:
28282300
DOI:
10.1097/QAI.0000000000001350
[Indexed for MEDLINE]

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