Clinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP31-3, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Clin Pharmacokinet. 2017 Oct;56(10):1103-1113. doi: 10.1007/s40262-017-0518-4.
Ombitasvir is a potent, nonstructural protein 5A inhibitor of the hepatitis C virus (HCV) that is used in combination with other direct-acting antivirals for the treatment of chronic HCV infection. Ombitasvir is predominantly metabolized by amide hydrolysis followed by oxidative metabolism and is a substrate of P-glycoprotein. Ombitasvir displays linear pharmacokinetics with minimal accumulation and is eliminated via metabolism and biliary excretion. A negligible amount of unchanged drug is excreted in urine. Exposures are comparable across Chinese, Japanese, and non-Asian subjects. The pharmacokinetic characteristics of ombitasvir are similar in healthy subjects and HCV-infected patients, and are not appreciably altered by hepatic or renal impairment. Results from several drug interaction studies demonstrated that ombitasvir has a low potential for drug interactions.
奥比他韦是一种有效的丙型肝炎病毒（HCV）非结构蛋白 5A 抑制剂，与其他直接作用抗病毒药物联合用于治疗慢性 HCV 感染。奥比他韦主要通过酰胺水解代谢，随后进行氧化代谢，是 P 糖蛋白的底物。奥比他韦的药代动力学呈线性，蓄积最小，通过代谢和胆汁排泄消除。几乎没有未改变的药物从尿液中排泄。在中、日、非亚洲人群中，暴露量是可比的。奥比他韦在健康受试者和 HCV 感染患者中的药代动力学特征相似，且肝或肾功能损害不会明显改变其药代动力学特征。多项药物相互作用研究的结果表明，奥比他韦的药物相互作用潜力较低。
