NDLI: Liver-to-plasma vaniprevir (MK-7009) concentration ratios in HCV-infected patients.

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Liver-to-plasma vaniprevir (MK-7009) concentration ratios in HCV-infected patients.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Wright, D. Hamish Caro, Luzelena Cerra, Michael Panorchan, Paul Du, Lihong Anderson, Melanie Potthoff, Andrej Nachbar, Robert B. Wagner, John Manns, Michael P. Talal, Andrew H.
Description	Country affiliation: United States Author Affiliation: Wright DH ( Merck and Company, Whitehouse Station, NJ, USA.)
Abstract	BACKGROUND: Some drugs that are actively taken up into the liver exhibit greater than dose proportional increases in plasma exposure, although human liver-to-plasma concentration ratios have rarely been evaluated. Understanding these relationships has implications for drug concentrations at the target site for certain classes of compounds, such as direct-acting antivirals, targeted towards HCV. METHODS: Treatment-experienced, chronic HCV non-cirrhotic patients (n=3) received vaniprevir (600 mg or 300 mg twice daily) on days 1-3 and (600 mg or 300 mg single dose) on day 4. Core needle biopsy was performed at 6 or 12 h post-dose on day 4. Blood samples were collected pre-dose on days 1 and 4, and for 24 h post-dose on day 4. The primary study objective was the hepatic concentration of vaniprevir at 6 and 12 h post-dose. RESULTS: Vaniprevir plasma pharmacokinetic parameters increased in a greater than dose-proportional manner between the 300 mg and 600 mg doses, with approximately fivefold increases in AUC0-12 and Cmax associated with a twofold increase in dose (AUC0-12, 10.6 µM/h to 59.5 µM/h; Cmax, 2.60 µM to 13.5 µM). In the 300 mg and 600 mg dose groups, mean liver concentrations of vaniprevir were 84.6 µM and 169 µM at 6 h post-dose, and 29.4 µM and 53.7 µM at 12 h post-dose. Liver concentrations were higher than plasma with liver-to-plasma concentration ratios of approximately 20-280. CONCLUSIONS: These data confirm higher vaniprevir concentrations in human liver compared with plasma and demonstrate that measurement of human liver drug concentration using needle biopsy is feasible.
File Format	HTM / HTML
ISSN	13596535
e-ISSN	20402058
DOI	10.3851/IMP2958
Journal	Antiviral Therapy
Issue Number	8
Volume Number	20
Language	English
Publisher	International Medical Press
Publisher Date	2015-01-01
Publisher Place	Great Britain (UK)
Access Restriction	Open
Subject Keyword	Discipline Virology Antiviral Agents Administration & Dosage Pharmacokinetics Hepacivirus Hepatitis C, Chronic Drug Therapy Virology Indoles Liver Metabolism Administration, Oral Biopsy Drug Monitoring Genetics Complications Diagnosis Pathology Liver Cirrhosis Etiology Clinical Trial Research Support, N.i.h., Extramural Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases Pharmacology Pharmacology (medical)

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