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10.1097/QAI.0000000000000908

http://scihub22266oqcxt.onion/10.1097/QAI.0000000000000908
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suck abstract from ncbi


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pmid26627107
      J+Acquir+Immune+Defic+Syndr 2016 ; 71 (5 ): 530-7
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  • 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.
  • |*Drug Substitution [MESH]
  • |Adult [MESH]
  • |Albuminuria/etiology [MESH]
  • |Bone Density/drug effects [MESH]
  • |Cobicistat/*therapeutic use [MESH]
  • |Drug Therapy, Combination [MESH]
  • |Emtricitabine/*therapeutic use [MESH]
  • |Female [MESH]
  • |Glomerular Filtration Rate/drug effects [MESH]
  • |HIV Infections/complications/*drug therapy [MESH]
  • |Humans [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]
  • |Proteinuria/etiology [MESH]
  • |Quinolones/*therapeutic use [MESH]
  • |Renal Insufficiency/etiology/physiopathology/*prevention & control [MESH]


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