Fine-Needle Aspiration for the Evaluation of Hepatic Pharmacokinetics of Vaniprevir: A Randomized Trial in Patients With Hepatitis C Virus Infection.
Adult
Antiviral Agents
/ administration & dosage
Biopsy, Fine-Needle
/ methods
Cyclopropanes
/ administration & dosage
Female
Genotype
Hepacivirus
/ genetics
Hepatitis C, Chronic
/ drug therapy
Humans
Isoindoles
/ administration & dosage
Lactams, Macrocyclic
/ administration & dosage
Leucine
/ administration & dosage
Liver
/ metabolism
Male
Middle Aged
Proline
/ administration & dosage
Sulfonamides
/ administration & dosage
Tissue Distribution
Young Adult
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
25
07
2019
accepted:
31
10
2019
pubmed:
24
12
2019
medline:
17
2
2021
entrez:
24
12
2019
Statut:
ppublish
Résumé
Fine-needle aspiration (FNA) for serial hepatic sampling may be an efficient and less invasive alternative to core needle biopsy (CNB), the current standard for liver tissue sampling. In this randomized, open-label trial in 31 participants with hepatitis C virus genotype 1 infection (NCT01678131/Merck protocol PN048), we evaluated the feasibility of using FNA to obtain human liver tissue samples appropriate for measuring hepatic pharmacokinetics (PK), using vaniprevir as a tool compound. The primary end point was successful retrieval of liver tissue specimens with measurable vaniprevir concentrations at two of three specified FNA time points. Twenty-nine patients met the primary end point and, therefore, were included in the PK analyses. Hepatic vaniprevir concentrations obtained with FNA were consistent with known vaniprevir PK properties. The shape of liver FNA and CNB concentration-time profiles were comparable. In conclusion, FNA may be effective for serial tissue sampling to assess hepatic drug exposure in patients with liver disease.
Substances chimiques
Antiviral Agents
0
Cyclopropanes
0
Isoindoles
0
Lactams, Macrocyclic
0
Sulfonamides
0
Proline
9DLQ4CIU6V
vaniprevir
CV3X74AO1H
Leucine
GMW67QNF9C
Banques de données
ClinicalTrials.gov
['NCT01678131']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1325-1333Informations de copyright
© 2019 Merck Sharp & Dohme Corp. Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
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