title: Clinical Pharmacokinetics of Ombitasvir.
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.
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP31-3, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
authors.forename: Prajakta S
authors.initials: PS
authors.lastname: Badri
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP31-3, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
authors.forename: Diana L
authors.initials: DL
authors.lastname: Shuster
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP31-3, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Dutta
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP31-3, 1 North Waukegan Road, North Chicago, IL, 60064, USA. Rajeev.menon@abbvie.com.
authors.forename: Rajeev M
authors.initials: RM
authors.lastname: Menon
mesh_terms: D000813:Anilides / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D000818:Animals; D000998:Antiviral Agents / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D002219:Carbamates / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D004347:Drug Interactions / Q000502:physiology; D004359:Drug Therapy, Combination; D018565:Food-Drug Interactions / Q000502:physiology; D016174:Hepacivirus / Q000187:drug effects*; D019698:Hepatitis C, Chronic / Q000097:blood* / Q000188:drug therapy*; D006801:Humans; D011392:Proline; D014633:Valine
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D002219:Carbamates; C586094:ombitasvir; D011392:Proline; D014633:Valine
keywords: Amide Hydrolysis; Drug Interaction Study; Ritonavir; Sustained Virologic Response Rate