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J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.

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.

Author information

1
*Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom; †Department of Medicine, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain; ‡Therapeutic Concepts, Houston, TX; §Department of Medicine, Indiana University School of Medicine, Indianapolis, IN; ‖King's College Hospital NHS Foundation Trust, London, United Kingdom; ¶Holdsworth House Medical Practice, Sydney, Australia; #HIV-NAT, Thai Red Cross AIDS Research Centre and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; **Gordon Crofoot Research, Houston, TX; ††Be Well Medical Center, Berkley, MI; ‡‡Department of Medicine, National Jewish Health, Denver, CO; §§Midway Research Center, Ft. Pierce, FL; ‖‖Department of Medicine, Khon Kaen University, Thailand; and ¶¶Gilead Sciences, Foster City, CA.

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.

PMID:
26627107
PMCID:
PMC4804743
DOI:
10.1097/QAI.0000000000000908
[Indexed for MEDLINE]
Free PMC Article

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