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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

par Wohl, David;Cheret, Antoine;Brunetta, Jason;Mussini, Cristina;Tebas, Pablo;Sax, Paul Edward Dward P.E.;Cheng, Andrew K;Zhong, Lijie;Callebaut, Christian;Das, Moupali;Fordyce, Marshall;Oka, Shinichi;Friborg, Sandra;Villamejor, Kathleen;Huang, Jay;Guo, Susan;Liu, Hui;Wang, Hui;Miller, Michael;Margot, Nicolas;Clumeck, Nathan ;Clarke, Amanda;Brinson, Cynthia;Stephens, Jeffrey;Tashima, Karen;Arribas, Jose;Rashbaum, Bruce
Référence Journal of acquired immune deficiency syndromes, 72, 1, page (58-64)
Publication Publié, 2016-05

Article révisé par les pairs

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Résumé :

In 2 double-blinded Phase 3 trials, 1733 antiretroviralnaive 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: 21.8% 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, welltolerated, and durable regimen for initial HIV-1 treatment.