Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results

J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.

Abstract

In 2 double-blinded Phase 3 trials, 1733 antiretroviral-naive participants were randomized to tenofovir alafenamide (TAF), a tenofovir prodrug versus tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 96 weeks, 86.6% in the TAF arm and 85.2% in the TDF arm had HIV-1 RNA <50 c/mL [difference 1.5%; (95% CI: -1.8% to 4.8%)]. With TAF, there are smaller declines in bone mineral density and more favorable changes in proteinuria, albuminuria, and tubular proteinuria, and no cases of proximal tubulopathy compared with 2 for TDF. These longer-term data support E/C/F/TAF as a safe, well-tolerated, and durable regimen for initial HIV-1 treatment.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Albuminuria / pathology
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Bone Density / drug effects
  • CD4 Lymphocyte Count
  • Cobicistat / adverse effects
  • Cobicistat / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Emtricitabine / adverse effects
  • Emtricitabine / therapeutic use*
  • Female
  • HIV Infections / drug therapy*
  • HIV-1 / drug effects
  • Humans
  • Male
  • Proteinuria / pathology
  • Quinolones / adverse effects
  • Quinolones / therapeutic use*
  • RNA, Viral / blood
  • Tenofovir / adverse effects
  • Tenofovir / therapeutic use*

Substances

  • Anti-HIV Agents
  • Drug Combinations
  • JTK 303
  • Quinolones
  • RNA, Viral
  • Tenofovir
  • tenofovir alafenamide
  • Emtricitabine
  • Adenine
  • Cobicistat