Single-dose pharmacokinetics of boceprevir in subjects with impaired hepatic or renal function

Clinical Pharmacokinetics

Volumn 51, Issue 9, 2012, Pages 619-628

  Treitel, Michelle ^a   Marbury, Thomas ^b   Preston, Richard A ^c   Triantafyllou, Ilias ^a   Feely, William ^a   Omara, Edward ^a   Kasserra, Claudia ^a   Gupta, Samir ^a   Hughes, Eric A ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b ORLANDO CLINICAL RESEARCH CENTER   (United States)

^c UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

boceprevir; haemodialysis; hepatitis C; hepatitis C virus NS3 protein inhibitors; liver dysfunction; liver function; pharmacokinetics; renal failure; renal function

Indexed keywords

BOCEPREVIR; DRUG METABOLITE; SCH 534128; SCH 534129; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMODIALYSIS PATIENT; HUMAN; KIDNEY FAILURE; LIVER FAILURE; MALE; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADOLESCENT; ADULT; AGED; FEMALE; HUMANS; KIDNEY FAILURE, CHRONIC; LIVER DISEASES; MALE; MIDDLE AGED; PROLINE; PROTEASE INHIBITORS; RENAL DIALYSIS; YOUNG ADULT;

EID: 84864756342     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11633440-000000000-00000     Document Type: Article

References (18)

1. Malcolm BA, Liu R, Lahser F, et al.SCH 503034, a mechanism-based inhibitor of hepatitis C virus NS3 protease, suppresses polyprotein maturation and enhances the antiviral activity of alpha interferon in replicon cells. Antimicrob Agents Chemother 2006; 50: 1013-20 (Pubitemid 43327807)
2. Kwo PY, Lawitz EJ, McCone J, et al. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet 2010; 376: 705-16
3. Bacon B, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1207-17
4. Poordad F, McCone J, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1195-206
5. Wise M, Bialek S, Finelli L, et al. Changing trends in hepatitis C-related mortality in the United States, 1995-2004. Hepatology 2008; 47: 1128-35 (Pubitemid 351547899)
6. Brown Jr RS, Gaglio PJ. Scope of worldwide hepatitis C problem. Liver Transplant 2003; 9 Suppl. 3: S10-3
7. Ghosal A, Yuan Y, Tong W, et al. Characterization of human liver enzymes involved in the biotransformation of boceprevir, a HCV protease inhibitor. Drug Metab Pharmacokinet 2011; 39: 510-21
8. Victrelis-(boceprevir) prescribing information. Whitehouse Station (NJ): Schering Corporation, a subsidiary of Merck & Co., Inc., 2011
9. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. US Food and Drug Administration Web site: 1-16 online. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm072123.pdf Accessed 2012 Feb 12
10. Pugh RNH, Murray-Lyon IM, Dawson JL, et al. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg 1973; 60: 646-9
11. Farnik H, El-Duweik J, Welsch C, et al. Highly sensitive determination ofHCV protease inhibitors boceprevir (SCH 503034) and telaprevir (VX 950) in human plasma by LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci 2009; 877: 4001-6
12. Data on file, Merck, 2010
13. PegIntron-(peginterferon alfa-2b) prescribing information. Kenilworth (NJ): Schering Corporation, 2008 Mar
14. Rebetol-(ribavirin UPS) capsules, oral solution prescribing information. Kenilworth (NJ): Schering Corporation, 2009 Nov
15. Fabrizi F, Poordad FF, Martin P. Hepatitis C infection and the patient with end-stage renal disease. Hepatology 2002; 36: 3-10 (Pubitemid 34700756)
16. Sarrazin C, Rouzier R, Wagner F, et al. SCH 503034, a novel hepatitis C virus protease inhibitor, plus pegylated interferon alpha 2b for genotype 1 nonresponders. Gastroenterology 2007; 132: 1270-8 (Pubitemid 46627577)
17. Data on file, Merck, 2008
18. Data on file, Merck, 2007