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J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):180-184. doi: 10.1097/QAI.0000000000001186.

Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study.

Author information

1
*Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, United Kingdom; †Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; ‡Department of Sexual Health, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; §Department of Infectious Diseases, Croix-Rousse Hospital, Hospices Civils de Lyon, France; and ‖Gilead Sciences, Inc., Foster City, CA.

Abstract

Tenofovir disoproxil fumarate is associated with renal and bone toxicity. In a single-arm, open-label study of 242 virologically suppressed, HIV-infected participants with creatinine clearance 30-69 mL/min who switched to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, participants had stable creatinine clearance, significant and durable improvements in proteinuria, albuminuria, and tubular proteinuria (P < 0.001), and significant increases in hip and spine bone mineral density through 96 weeks (P < 0.001). Eighty-eight percent maintained HIV-1 RNA <50 c/mL at week 96. These longer-term results support the use of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in HIV-infected individuals with mild-moderately impaired renal function.

PMID:
27673443
PMCID:
PMC5228610
DOI:
10.1097/QAI.0000000000001186
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

F.A.P. reports receiving research grant to institution from Gilead and ViiV, and personal fees from Gilead, ViiV, Janssen, MSD, and Abbvie. P.T. reports receiving consulting fees from Merck and research grant to institution for Gilead trials and has serve on adjudication committee for GlaxoSmithKline. L.C. has received research grants from MSD, and ViiV; personal fees from Mylan; and nonfinancial support from MSD, ViiV, Janssen, Gilead, and BMS. M.E.A., S.J., A. Cheng, M.D., and M.W.F. are employees of Gilead and hold stock interest in the company. The remaining authors have no conflicts of interest to disclose.

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