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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Acquir+Immune+Defic+Syndr
2016 ; 71
(5
): 530-7
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat,
and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week
Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study
#MMPMID26627107
Pozniak A
; Arribas JR
; Gathe J
; Gupta SK
; Post FA
; Bloch M
; Avihingsanon A
; Crofoot G
; Benson P
; Lichtenstein K
; Ramgopal M
; Chetchotisakd P
; Custodio JM
; Abram ME
; Wei X
; Cheng A
; McCallister S
; SenGupta D
; Fordyce MW
J Acquir Immune Defic Syndr
2016[Apr]; 71
(5
): 530-7
PMID26627107
show ga
BACKGROUND: Tenofovir alafenamide (TAF) is a novel tenofovir prodrug with
improved renal and bone safety compared with TDF-containing regimens. We report
the 48 week safety and efficacy of a once-daily single tablet regimen of
elvitegravir 150 mg (E), cobicistat 150 mg (C), emtricitabine 200 mg (F), and TAF
10 mg (E/C/F/TAF) in HIV-1-infected patients with mild to moderate renal
impairment. METHODS: We enrolled virologically suppressed HIV-1-infected subjects
with estimated creatinine clearance (CrCl) 30-69 mL/min in a single-arm,
open-label study to switch regimens to E/C/F/TAF. The primary endpoint was the
change from baseline in glomerular filtration rate estimated using various
formulae. This study is registered with ClinicalTrials.gov, number NCT01818596.
FINDINGS: We enrolled and treated 242 patients with mean age 58 years, 18% Black,
39% hypertension, 14% diabetes. Through week 48, no significant change in
estimated CrCl was observed. Two patients (0.8%) discontinued study drug for
decreased creatinine clearance, neither had evidence of renal tubulopathy and
both had uncontrolled hypertension. Subjects had significant improvements in
proteinuria, albuminuria, and tubular proteinuria (P < 0.001 for all). Hip and
spine bone mineral density significantly increased from baseline to week 48 (mean
percent change +1.47 and +2.29, respectively, P < 0.05). Ninety-two percent (222
patients) maintained HIV-1 RNA <50 copies per milliliter at week 48.
INTERPRETATION: Switch to E/C/F/TAF was associated with minimal change in GFR.
Proteinuria, albuminuria and bone mineral density significantly improved. These
data support the efficacy and safety of once daily E/C/F/TAF in HIV+ patients
with mild or moderate renal impairment without dose adjustment.