Does an increase in serum creatinine always reflect renal injury? The case of Stribild®

Vikram Arya; Jeffry Florian; Kendall A Marcus; Kellie S Reynolds; Linda L Lewis; Adam I Sherwat

doi:10.1002/jcph.223

Does an increase in serum creatinine always reflect renal injury? The case of Stribild®

J Clin Pharmacol. 2013 Nov 8. doi: 10.1002/jcph.223. Online ahead of print.

Authors

Vikram Arya¹, Jeffry Florian, Kendall A Marcus, Kellie S Reynolds, Linda L Lewis, Adam I Sherwat

Affiliation

¹ Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

PMID: 24214102
DOI: 10.1002/jcph.223

Abstract

Single tablet, once-daily HIV treatment regimens offer patient convenience, the potential for increased adherence, and fewer patient-related dosing errors^[1] . Stribild® (manufactured and marketed by Gilead Sciences; referred to as "applicant" in this report), a 4-drug fixed-dose combination (FDC) tablet, is approved for the treatment of HIV-1 infection in treatment-naïve adult patients. Stribild® contains elvitegravir (an integrase strand transfer inhibitor), cobicistat (an inhibitor of cytochrome P450 enzymes), and the nucleoside/nucleotide reverse transcriptase inhibitors emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF).

Keywords: MATE 1 transporters; Stribild®; creatinine clearance; renal tubulopathy.