Effect of Hepatic Impairment on the Pharmacokinetics of Grazoprevir, a Hepatitis C Virus Protease Inhibitor
Luzelena Caro, Larissa Wenning, Zifang Guo, Iain P Fraser, Christine Fandozzi, Jennifer Talaty, Deborah Panebianco, Maureen Ho, Naoto Uemura, Christina Reitmann, Peter Angus, Edward Gane, Thomas Marbury, William B Smith, Marian Iwamoto, Joan R Butterton, Wendy W Yeh
Antimicrobial Agents and Chemotherapy | AMER SOC MICROBIOLOGY | Published : 2017
Grazoprevir (GZR) plus elbasvir is an approved treatment for chronic infection with hepatitis C virus (HCV) genotype 1 or 4. HCV infection complications include liver cirrhosis, end-stage liver disease, and hepatocellular carcinoma. The objective of this study was to evaluate the pharmacokinetics and safety of multiple-dose GZR (200, 100, or 50 mg) in non-HCV participants with mild, moderate, or severe hepatic impairment (HI), respectively, and in healthy matched controls (protocol MK-5172_p013; Merck & Co., Inc., Kenilworth, NJ). Participants with mild, moderate, or severe HI and controls (aged 18 to 65 years) matched for race, age, sex, and body mass index were enrolled in a 3-part, open-l..View full abstract
This study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Medical writing and editorial assistance were provided by Shaylin Shadanbaz and Tim Ibbotson of ApotheCom. This assistance was funded by Merck Sharp & Dohme Corp.L.C., L.W., Z.G., C.F., J.T., D.P., M.H., M.I., J.R.B., and W.W.Y. are current employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. I.P.F., N.U., and C.R. were employees of Merck Sharp & Dohme Corp. at the time the studies were conducted. I.P.F. owns stock in Merck. P.A. has no conflicts to disclose. E.G. has sat on advisory boards for Merck, Gilead, AbbVie, and Janssen and has been a speaker for Gilead and AbbVie. T.M. has received research grant support from Merck and owns stock in Orlando Clinical Research Center. W.B.S. has received research grant support from Merck.