Effect of telaprevir on the pharmacokinetics of midazolam and digoxin

Journal of Clinical Pharmacology

Volumn 52, Issue 10, 2012, Pages 1566-1573

  Garg, Varun ^a   Chandorkar, Gurudatt ^a,b   Farmer, H Frank ^c   Smith, Frances ^a   Alves, Katia ^a   Van Heeswijk, Rolf P G ^d  

^a VERTEX PHARMACEUTICALS   (United States)

^b CUBIST PHARMACEUTICALS INC   (United States)

^c Covance Research Unit ^*  (United States)

^d TIBOTEC BVBA   (Belgium)

Author keywords

digoxin; drug interaction; Midazolam; telaprevir

Indexed keywords

DIGOXIN; MIDAZOLAM; TELAPREVIR;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONCENTRATION RESPONSE; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG URINE LEVEL; FEMALE; FOLLOW UP; HUMAN; HUMAN EXPERIMENT; KIDNEY CLEARANCE; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; OPEN STUDY; SAMPLE SIZE; SINGLE DRUG DOSE; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADOLESCENT; ADULT; ANTIVIRAL AGENTS; AREA UNDER CURVE; CYTOCHROME P-450 CYP3A; DIGOXIN; DRUG INTERACTIONS; FEMALE; HUMANS; MALE; MIDAZOLAM; MIDDLE AGED; OLIGOPEPTIDES; P-GLYCOPROTEIN; PROTEASE INHIBITORS; YOUNG ADULT;

EID: 84858786523     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011419850     Document Type: Article

References (16)

1. Lin C, Kwong AD, Perni RB. Discovery and development of VX-950, a novel, covalent, and reversible inhibitor of hepatitis C virus NS3.4A serine protease. Infect Disord Drug Targets. 2006 ; 6: 3-16
2. Jacobson IM, McHutchison JG, Dusheiko GM, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 ; 364: 2405-2416
3. Sherman KE, Flamm SL, Afdhal NH, et al. Telaprevir in combination with peginterferon alfa-2a and ribavirin for 24 or 48 weeks in treatment-naïve genotype 1 HCV patients who achieved an extended rapid viral response: final results of Phase 3 ILLUMINATE study. Hepatol. 2010 ; 52 (suppl 4). 401A - 402A
4. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 ; 364: 2417-2428
5. Hézode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 ; 360: 1839-1850
6. McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection [Published correction appears in N Engl J Med. 2009;361:1516]. N Engl J Med. 2009 ; 360: 1827-1838
7. McHutchison JG, Manns MP, Muir AJ, et al. Telaprevir for previously treated chronic HCV infection [Published correction appears in N Engl J Med. 2010;362:1647]. N Engl J Med. 2010 ; 362: 1292-1303
8. Food and Drug Administration. FDA, CDER, and CBER Guidance for Industry. Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling.
9. Kirby B, Kharasch ED, Thummel KT, Narang VS, Hoffer CJ, Unadkat JD. Simultaneous measurement of in vivo P-glycoprotein and cytochrome P450 3A activities. J Clin Pharmacol. 2006 ; 46: 1313-1319
10. Martin DE, Tompson D, Boike SC, et al. Lack of effect of eprosartan on the single dose pharmacokinetics of orally administered digoxin in healthy male volunteers. Br J Clin Pharmacol. 1997 ; 43: 661-664
11. Gorski JC, Vannaprasaht S, Hamman MA, et al. The effect of age, sex and rifampin administration on intestinal and hepatic cytochrome P450 3A activity. Clin Pharmacol Ther. 2003 ; 74: 275-287
12. Incivek [package insert]. http://www.accessdata.fda.gov/drugsatfda/docs/ label/2011/201917lbl.pdf. Accessed June 27, 2011.
13. Midazolam [package insert]. http://www.drugs.com/pro/midazolam-injection. html. Accessed June 27, 2011.
14. Invirase [package insert]. http://www.gene.com/gene/products/information/ invirase/pdf/pi.pdf. Accessed June 27, 2011.
15. van HeeswijkRVandevoordeABoogaertsG. Pharmacokinetic Interactions Between Antiretroviral Agents and the Investigational HCV Protease Inhibitor Telaprevir in Healthy Volunteers. Presentation 119 at the Conference on Retroviruses and Opportunistic Infection; 2011. http://www.retroconference.org/2011/Abstracts/ 41437.htm. Accessed June 27, 2011.
16. Li C, Liu T, Broske L, et al. Permeability evaluation of peptidic HCV protease inhibitors in Caco-2 cells-correlation with in vivo absorption predicted in humans. Biochem Pharmacol. 2008 ; 76: 1757-1764