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

David Wohl; Shinichi Oka; Nathan Clumeck; Amanda Clarke; Cynthia Brinson; Jeffrey Stephens; Karen Tashima; Jose R Arribas; Bruce Rashbaum; Antoine Cheret; Jason Brunetta; Cristina Mussini; Pablo Tebas; Paul E Sax; Andrew Cheng; Lijie Zhong; Christian Callebaut; Moupali Das; Marshall Fordyce; GS-US-2,92-01040111 and Study Team

doi:10.1097/QAI.0000000000000940

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.

Affiliation

¹ *Department of Medicine, University of North Carolina, Chapel Hill, NC; †AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan; ‡Department of Infectious Diseases, CHU Saint-Pierre University Hospital Brussels, Brussels, Belgium; §Elton John centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; ‖Central Texas Clinical Research, Austin, TX; ¶Department of Internal Medicine, Mercer University School of Medicine, Macon, GA; #The Miriam Hospital, Alpert Medical School of Brown University, Providence, RI; **Infectious Diseases Unit, Internal Medicine Service, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain; ††Capital Center for Travel and Tropical Medicine, Washington, DC; ‡‡Internal Medicine Unit, Le Kremlin-Bicêtre Hospital, AP-HP Infectious Diseases Unit, Centre Hospitalier de Tourcoing Descartes University, Necker Hospital, AP-HP, Paris, France; §§Medicine, Maple Leaf Research, Department of Family and Community Medicine, University of Toronto, Toronto, CA; ‖‖Clinica delle Malattie Infettive e Tropicali, University of Modena and Reggio Emilia, Modena, Italy; ¶¶Department of Medicine and Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; ##Division of Infectious Diseases and Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA; and ***Gilead Sciences, Foster City, CA.

PMID: 26829661
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
Alanine
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
Quinolones
RNA, Viral
elvitegravir
Tenofovir
tenofovir alafenamide
Emtricitabine
Adenine
Cobicistat
Alanine