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Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomized, double-blind, active-controlled phase 3 trial().

Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomized, double-blind, active-controlled phase 3 trial().
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Post FA, Yazdanpanah Y, Schembri G, Lazzarin A, Reynes J, Maggiolo F, Yan M, Abram ME, Tran-Muchowski C, Cheng A, Rhee MS,


Post FA, Yazdanpanah Y, Schembri G, Lazzarin A, Reynes J, Maggiolo F, Yan M, Abram ME, Tran-Muchowski C, Cheng A, Rhee MS, (click to view)

Post FA, Yazdanpanah Y, Schembri G, Lazzarin A, Reynes J, Maggiolo F, Yan M, Abram ME, Tran-Muchowski C, Cheng A, Rhee MS,

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HIV clinical trials 2017 03 17() 1-6 doi 10.1080/15284336.2017.1291867

Abstract
BACKGROUND
FTC/TAF was shown to be noninferior to FTC/TDF with advantages in markers of renal and bone safety.

OBJECTIVE
To evaluate the efficacy and safety of switching to FTC/TAF from FTC/TDF by third agent (boosted protease inhibitor [PI] vs. unboosted third agent).

METHODS
We conducted a 48-week subgroup analysis based on third agent from a randomized, double blind study in virologically suppressed adults on a FTC/TDF-containing regimen who switched to FTC/TAF vs. continued FTC/TDF while remaining on the same third agent.

RESULTS
We randomized (1:1) 663 participants to either switch to FTC/TAF (N = 333) or continue FTC/TDF (N = 330), each with baseline third agent stratifying by class of third agent in the prior treatment regimen (boosted PI 46%, unboosted third agent 54%). At week 48, significant differences in renal biomarkers and bone mineral density were observed favoring FTC/TAF over FTC/TDF (p < 0.05 for all), with similar improvements in the FTC/TAF arm in those who received boosted PI vs. unboosted third agents. At week 48, virologic success rates were similar between treatment groups for those who received a boosted PI (FTC/TAF 92%, FTC/TDF 93%) and for those who received an unboosted third agent (97% vs. 93%). CONCLUSIONS
In virologically suppressed patients switching to FTC/TAF from FTC/TDF, high rates of virologic suppression were maintained, while renal and bone safety parameters improved, regardless of whether participants were receiving a boosted PI or an unboosted third agent. FTC/TAF offers safety advantages over FTC/TDF and can be an important option as an NRTI backbone given with a variety of third agents.

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