Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: 48 week results from a single-arm, multi-center, open-label, Phase 3 study

for the GS-US-292-0112 Study Team

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Abstract

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-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 Week48 (mean percent change +1.47 and +2.29, respectively, p

Original languageEnglish (US)
JournalJournal of Acquired Immune Deficiency Syndromes
DOIs
StateAccepted/In press - Nov 30 2015

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HIV
Kidney
Creatinine
Tenofovir
Proteinuria
Pelvic Bones
Hypertension
Safety
Albuminuria
Prodrugs
Glomerular Filtration Rate
Bone Density
Tablets
HIV-1
Spine
Bone and Bones
GS-7340
Emtricitabine
JTK 303
Cobicistat

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

@article{8e199357baea43ae842b4155d8c7787b,
title = "Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: 48 week results from a single-arm, multi-center, open-label, Phase 3 study",
abstract = "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-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 Week48 (mean percent change +1.47 and +2.29, respectively, p",
author = "{for the GS-US-292-0112 Study Team} and Anton Pozniak and Arribas, {Jose R R} and Joseph Gathe and Samir Gupta and Post, {Frank A A} and Mark Bloch and Anchalee Avihingsanon and Gordon Crofoot and Paul Benson and Kenneth Lichtenstein and Moti Ramgopal and Ploenchan Chetchotisakd and Custodio, {Joseph M M} and Abram, {Michael E E} and Xuelian Wei and Andrew Cheng and Scott McCallister and Devi SenGupta and Fordyce, {Marshall W W}",
year = "2015",
month = "11",
day = "30",
doi = "10.1097/QAI.0000000000000908",
language = "English (US)",
journal = "Journal of Acquired Immune Deficiency Syndromes",
issn = "1525-4135",
publisher = "Lippincott Williams and Wilkins",

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TY - JOUR

T1 - Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment

T2 - 48 week results from a single-arm, multi-center, open-label, Phase 3 study

AU - for the GS-US-292-0112 Study Team

AU - Pozniak, Anton

AU - Arribas, Jose R R

AU - Gathe, Joseph

AU - Gupta, Samir

AU - Post, Frank A A

AU - Bloch, Mark

AU - Avihingsanon, Anchalee

AU - Crofoot, Gordon

AU - Benson, Paul

AU - Lichtenstein, Kenneth

AU - Ramgopal, Moti

AU - Chetchotisakd, Ploenchan

AU - Custodio, Joseph M M

AU - Abram, Michael E E

AU - Wei, Xuelian

AU - Cheng, Andrew

AU - McCallister, Scott

AU - SenGupta, Devi

AU - Fordyce, Marshall W W

PY - 2015/11/30

Y1 - 2015/11/30

N2 - 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-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 Week48 (mean percent change +1.47 and +2.29, respectively, p

AB - 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-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 Week48 (mean percent change +1.47 and +2.29, respectively, p

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U2 - 10.1097/QAI.0000000000000908

DO - 10.1097/QAI.0000000000000908

M3 - Article

C2 - 26627107

AN - SCOPUS:84949035010

JO - Journal of Acquired Immune Deficiency Syndromes

JF - Journal of Acquired Immune Deficiency Syndromes

SN - 1525-4135

ER -