Does an increase in serum creatinine always reflect renal injury? The case of Stribild®
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).
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.
Vikram
V
Arya
Jeffry
J
Florian
Kendall A
KA
Marcus
Kellie S
KS
Reynolds
Linda L
LL
Lewis
Adam I
AI
Sherwat
MATE 1 transporters; Stribild®; creatinine clearance; renal tubulopathy