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
dc.contributor.author | Pozniak, Anton | |
dc.contributor.author | Arribas, Jose R. | |
dc.contributor.author | Gathe, Joseph | |
dc.contributor.author | Gupta, Samir K. | |
dc.contributor.author | Post, Frank A. | |
dc.contributor.author | Bloch, Mark | |
dc.contributor.author | Avihingsanon, Anchalee | |
dc.contributor.author | Crofoot, Gordon | |
dc.contributor.author | Benson, Paul | |
dc.contributor.author | Lichtenstein, Kenneth | |
dc.contributor.author | Ramgopal, Moti | |
dc.contributor.author | Chetchotisakd, Ploenchan | |
dc.contributor.author | Custodio, Joseph M. | |
dc.contributor.author | Abram, Michael E. | |
dc.contributor.author | Wei, Xuelian | |
dc.contributor.author | Cheng, Andrew | |
dc.contributor.author | McCallister, Scott | |
dc.contributor.author | SenGupta, Devi | |
dc.contributor.author | Fordyce, Marshall W. | |
dc.contributor.department | Department of Medicine, IU School of Medicine | en_US |
dc.date.accessioned | 2016-09-16T15:47:15Z | |
dc.date.available | 2016-09-16T15:47:15Z | |
dc.date.issued | 2016-04-15 | |
dc.description.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-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. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Pozniak, A., Arribas, J. R., Gathe, J., Gupta, S. K., Post, F. A., Bloch, M., … Fordyce, M. W. (2016). 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. Journal of Acquired Immune Deficiency Syndromes (1999), 71(5), 530–537. http://doi.org/10.1097/QAI.0000000000000908 | en_US |
dc.identifier.issn | 1944-7884 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/10946 | |
dc.language.iso | en_US | en_US |
dc.publisher | Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins | en_US |
dc.relation.isversionof | 10.1097/QAI.0000000000000908 | en_US |
dc.relation.journal | Journal of Acquired Immune Deficiency Syndromes (1999) | en_US |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.source | PMC | en_US |
dc.subject | Cobicistat | en_US |
dc.subject | therapeutic use | en_US |
dc.subject | Emtricitabine | en_US |
dc.subject | HIV Infections | en_US |
dc.subject | drug therapy | en_US |
dc.subject | Quinolones | en_US |
dc.subject | Renal Insufficiency | en_US |
dc.subject | prevention & control | en_US |
dc.subject | Tenofovir | en_US |
dc.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, Multicenter, Open-Label Phase 3 Study | en_US |
dc.type | Article | en_US |
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