Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment

作者：Anton Pozniak, José Ramón Arribas, Joseph Gathe, Samir K. Gupta, Frank A. Post, Mark Bloch, Anchalee Avihingsanon, Gordon Crofoot, Paul Benson, Kenneth Lichtenstein, Moti Ramgopal, Ploenchan Chetchotisakd, Joseph M. Custodio, Michael E. Abram, Xuelian Wei, Andrew Cheng, Scott McCallister, Devi SenGupta, Marshall W. Fordyce · 发表于：JAIDS Journal of Acquired Immune Deficiency Syndromes · 年份：2015 · DOI：10.1097/qai.0000000000000908 · 被引用次数：184 · 研究领域：HIV-related health complications and treatments、HIV/AIDS drug development and treatment、HIV Research and Treatment

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/...