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.
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.
*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.
Frank A
FA
Post
Pablo
P
Tebas
Amanda
A
Clarke
Laurent
L
Cotte
William R
WR
Short
Michael E
ME
Abram
Shuping
S
Jiang
Andrew
A
Cheng
Moupali
M
Das
Marshall W
MW
Fordyce
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D003404:Creatinine / Q000097:blood; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D011507:Proteinuria / Q000139:chemically induced; D051437:Renal Insufficiency / Q000139:chemically induced*; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
D019380:Anti-HIV Agents; D003404:Creatinine
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