Evaluation of the Pharmacokinetics and Renal Excretion of Simeprevir in Subjects with Renal Impairment

Background Simeprevir is a N3/4 protease inhibitor approved for the treatment of hepatitis C virus (HCV) infection. HCV prevalence is higher in patients with chronic kidney disease compared with the general population; safe and efficacious therapies in renal impairment are needed. Objectives To eval...

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Bibliographic Details
Published in:Drugs in R&D 2015-09, Vol.15 (3), p.261-270
Main Authors: Ouwerkerk-Mahadevan, Sivi, Beumont-Mauviel, Maria, Mortier, Steven, Peeters, Monika, Verloes, Rene, Truyers, Carla, Mannens, Geert, Wynant, Inneke, Simion, Alexandru
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Carbon Radioisotopes - blood
Carbon Radioisotopes - pharmacokinetics
Carbon Radioisotopes - urine
Feces - chemistry
Female
Humans
Internal Medicine
Male
Medicine
Medicine & Public Health
Middle Aged
Original
Original Research Article
Pharmacology/Toxicology
Pharmacotherapy
Protease Inhibitors - analysis
Protease Inhibitors - blood
Protease Inhibitors - pharmacokinetics
Protease Inhibitors - urine
Renal Insufficiency - metabolism
Renal Insufficiency - urine
Simeprevir - analysis
Simeprevir - blood
Simeprevir - pharmacokinetics
Simeprevir - urine
Young Adult
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Summary:Background Simeprevir is a N3/4 protease inhibitor approved for the treatment of hepatitis C virus (HCV) infection. HCV prevalence is higher in patients with chronic kidney disease compared with the general population; safe and efficacious therapies in renal impairment are needed. Objectives To evaluate simeprevir renal excretion in healthy subjects and to compare the simeprevir steady-state pharmacokinetics between subjects with severe renal impairment and healthy subjects. Methods In the mass balance study, healthy adults received a single 200-mg dose of 14 C-simeprevir; radioactivity in the urine and feces was quantified until concentrations were
ISSN:1174-5886
1179-6901
DOI:10.1007/s40268-015-0101-0