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. (1st June 2017)

• Record Type: Journal Article
• Authors: Arribas, José R.; Thompson, Melanie; Sax, Paul E.; Haas, Bernhard; McDonald, Cheryl; Wohl, David A.; DeJesus, Edwin; Clarke, Amanda E.; Guo, Susan; Wang, Hui; Callebaut, Christian; Plummer, Andrew; Cheng, Andrew; Das, Moupali; McCallister, Scott
• Is Part Of: Journal of acquired immune deficiency syndromes. Volume 75:Number 2(2017)
• Publication Date: 2017-06-01
• Subjects: tenofovir alafenamide -- integrase inhibitor -- randomized controlled trial -- HIV -- bone mineral density -- renal safety; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome -- Periodicals; AIDS (Disease); Periodicals; 616.9792005
• DOI: 10.1097/QAI.0000000000001350
• Languages: English
• ISSNs: 1525-4135

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is Available in the Text.