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.
Journal: Journal Of Acquired Immune Deficiency Syndromes (1999)
Published:
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.
Authors
David Wohl, Shinichi Oka, Nathan Clumeck, Amanda Clarke, Cynthia Brinson, Jeffrey Stephens, Karen Tashima, Jose Arribas, Bruce Rashbaum, Antoine Cheret, Jason Brunetta, Cristina Mussini, Pablo Tebas, Paul Sax, Andrew Cheng, Lijie Zhong, Christian Callebaut, Moupali Das, Marshall Fordyce
Relevant Conditions