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Review
. 2017 Oct;56(10):1103-1113.
doi: 10.1007/s40262-017-0518-4.

Clinical Pharmacokinetics of Ombitasvir

Prajakta S Badri  1 , Diana L Shuster  1 , Sandeep Dutta  1 , Rajeev M Menon  2
Affiliations
Review

Clinical Pharmacokinetics of Ombitasvir

Prajakta S Badri et al. Clin Pharmacokinet. 2017 Oct.

Abstract

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.

Keywords: Amide Hydrolysis; Drug Interaction Study; Ritonavir; Sustained Virologic Response Rate.

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