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.

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.

• Authors: Frank A Post, Pablo Tebas, Amanda Clarke, Laurent Cotte, William R Short, Michael E Abram, Shuping Jiang, Andrew Cheng, Moupali Das, Marshall W Fordyce
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 74 Issue 2 Pg. 180-184 (Feb 01 2017) ISSN: 1944-7884 [Electronic] United States
• PMID: 27673443 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)

Chemical References

• Anti-HIV Agents
• Creatinine

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-HIV Agents (administration & dosage, adverse effects)
• Antiretroviral Therapy, Highly Active (methods)
• Creatinine (blood)
• HIV Infections (complications, drug therapy)
• Humans
• Kidney Function Tests
• Male
• Metabolic Clearance Rate
• Middle Aged
• Proteinuria (chemically induced)
• Renal Insufficiency (chemically induced)
• Sustained Virologic Response
• Treatment Outcome
• Viral Load
• Young Adult