Scientific Publications by FDA Staff

J Clin Pharmacol 2014 Mar;54(3):279-81

Does an increase in serum creatinine always reflect renal injury? The case of Stribild(R).

Arya V, Florian J, Marcus KA, Reynolds KS, Lewis LL, Sherwat AI

Single tablet, once-daily HIV treatment regimens offer patient convenience, the potential for increased adherence, and fewer patient-related dosing errors[1] . Stribild(R) (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-naive adult patients. Stribild(R) 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).