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
| Autor: | Devi SenGupta, Frank A. Post, Michael E. Abram, Mark Bloch, Samir K. Gupta, Gordon Crofoot, Joseph M. Custodio, Anchalee Avihingsanon, Scott McCallister, Kenneth A. Lichtenstein, Moti Ramgopal, Xuelian Wei, Joseph Gathe, Ploenchan Chetchotisakd, Anton Pozniak, Jose R. Arribas, Paul M. Benson, Marshall W. Fordyce, Andrew K. Cheng |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Tenofovir 030106 microbiology Urology Renal function Phases of clinical research HIV Infections Pharmacology Quinolones Emtricitabine Tenofovir alafenamide 03 medical and health sciences 0302 clinical medicine Bone Density Medicine Albuminuria Humans Pharmacology (medical) tenofovir alafenamide 030212 general & internal medicine Renal Insufficiency business.industry Elvitegravir Drug Substitution Cobicistat HIV virus diseases Prodrug Clinical Science Middle Aged Proteinuria Infectious Diseases ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Drug Therapy Combination Female business bone mineral density chronic kidney disease medicine.drug Glomerular Filtration Rate |
| Zdroj: | Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid Journal of Acquired Immune Deficiency Syndromes (1999) |
| Popis: | Supplemental Digital Content is Available in the Text. 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 |
| Databáze: | OpenAIRE |
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