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.
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 / Wohl, D., Oka, S., Clumeck, N., Clarke, A., Brinson, C., Stephens, J., Tashima, K., Arribas, J.R., Rashbaum, B., Cheret, A., Brunetta, J., Mussini, C., Tebas, P., Sax, P.E., Cheng, A., Zhong, L., Callebaut, C., Das, M., Fordyce, M., Friborg, S., et al.. - In: JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES. - ISSN 1525-4135. - 72:1(2016), pp. 58-64. [10.1097/QAI.0000000000000940]
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
Mussini C.;
2016
Abstract
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.
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