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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0000000000000225
Original Article: PDF Only

Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate in Single Tablet Regimens for Initial HIV-1 Therapy: A Randomized Phase 2 Study.

Sax, Paul E MD; Zolopa, Andrew MD; Brar, Indira MD; Elion, Richard MD; Ortiz, Roberto MD; Post, Frank MD, PhD, FCP (SA); Wang, Hui PhD; Callebaut, Christian PhD; Martin, Hal MD, MPH; Fordyce, Marshall W. MD; McCallister, Scott MD

Published Ahead-of-Print
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Abstract

Objectives: To evaluate the safety and efficacy of the novel tenofovir prodrug, tenofovir alafenamide (TAF), as part of a single tablet regimen (STR) for initial treatment of HIV-1 infection.

Design: Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study.

Methods: Antiretroviral naive adults with HIV-1 RNA >= 5,000 copies/mL and CD4 count >= 50 cells/[micro]L were randomized 2:1 to receive a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), plus placebo for 48 weeks.

Results: Patients on both E/C/F/TAF (n=112) and E/C/F/TDF (n=58) had high rates of virologic suppression (<50 HIV copies/mL) at Week 24 (86.6%; 89.7%) and at Week 48 (88.4%; 87.9%), and had similar improvements in CD4 at Week 48 (177;204), respectively. Both treatments were well tolerated and most AEs were self-limiting and of mild to moderate severity. Compared with patients on E/C/F/TDF, patients on E/C/F/TAF had smaller reductions in estimated creatinine clearance (-5.5 mL/min vs. -10.1 mL/min, p=0.041), significantly less renal tubular proteinuria, and smaller changes in bone mineral density for hip (-0.62% vs. -2.39%, p<0.001) and spine (-1.00% vs. -3.37%, p<0.001). Patients on E/C/F/TAF had higher increases in total cholesterol, LDL and HDL, but the total cholesterol/HDL ratio was unchanged for both.

Conclusion: Treatment naive patients treated with an STR that contained either TAF or TDF achieved a high rate of virologic success. Compared to those receiving TDF, patients on E/C/F/TAF experienced significantly smaller changes in estimated creatinine clearance, renal tubular proteinuria, and bone mineral density.

(C) 2014 by Lippincott Williams & Wilkins

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