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

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

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Anti-HIV Agents / therapeutic use*
  • Bone Density / drug effects
  • CD4 Lymphocyte Count
  • Cobicistat / therapeutic use*
  • Double-Blind Method
  • Emtricitabine / therapeutic use*
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • Humans
  • Middle Aged
  • Quinolones / therapeutic use*
  • Tenofovir / therapeutic use*
  • Treatment Outcome
  • United States

Substances

  • Anti-HIV Agents
  • JTK 303
  • Quinolones
  • Tenofovir
  • GS-7340
  • Emtricitabine
  • Adenine
  • Cobicistat