Division of Clinical Pharmacology IV, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2017 Oct;102(4):578-580. doi: 10.1002/cpt.699. Epub 2017 Apr 26.
Dasabuvir, a component of VIEKIRA PAK, is a substrate of CYP2C8 enzymes. Prescribing information for VIEKIRA PAK contraindicates gemfibrozil, a strong CYP2C8 inhibitor, because coadministration significantly increases dasabuvir exposures, which may increase the risk of QT prolongation. Clopidogrel may increase dasabuvir exposures primarily due to CYP2C8 inhibition by clopidogrel-acyl-β-D-glucuronide. This commentary outlines the US Food and Drug Administration (FDA) interdisciplinary review team's scientific perspective to address the potential for a significant drug-drug interaction (DDI) between clopidogrel and VIEKIRA PAK.
达沙布韦是 Viekira Pak 的一种成分，是细胞色素 CYP2C8 酶的底物。Viekira Pak 的说明书禁止与吉非贝齐合用，因为吉非贝齐是一种强效的 CYP2C8 抑制剂，合用会显著增加达沙布韦的暴露量，从而增加发生 QT 延长的风险。氯吡格雷可能会增加达沙布韦的暴露量，主要是因为氯吡格雷酰基-β-D-葡糖苷酸对 CYP2C8 的抑制作用。本文概述了美国食品和药物管理局（FDA）跨学科审查小组的科学观点，以解决氯吡格雷与 Viekira Pak 之间发生重大药物相互作用（DDI）的可能性。
