FDA Approves a TAF-Containing Fixed-Dose Combination for Treatment of HIV Infection

Tenofovir alafenamide (TAF) enters cells more efficiently than tenofovir disoproxil fumarate (TDF; the current formulation of tenofovir) and can be given at a lower dose, resulting in 90% lower plasma tenofovir levels. On November 5, 2015, the FDA approved a fixed-dose combination of elvitegravir/cobicistat/FTC/TAF (E/C/FTC/TAF) for initial treatment of HIV-infected adults and adolescents. This approval was based on phase III randomized trials in treatment-naive HIV-infected patients, which demonstrated that TAF was noninferior to TDF in terms of virologic efficacy (NEJM JW Infect Dis Jun 2015 and Lancet 2015; 27:2606). Patients randomized to receive TAF had smaller reductions in estimated glomerular filtration rate, less proteinuria, and s…