Effect of telaprevir on the pharmacokinetics of buprenorphine in volunteers on stable buprenorphine/naloxone maintenance therapy

Antimicrobial Agents and Chemotherapy

Volumn 56, Issue 7, 2012, Pages 3641-3647

  Luo, Xia ^a   Trevejo, Jose ^a   Van Heeswijk, Rolf P G ^b   Smith, Frances ^a   Garga, Varun ^a  

^a VERTEX PHARMACEUTICALS   (United States)

^b JANSSEN RESEARCH FOUNDATION   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BUPRENORPHINE PLUS NALOXONE; NORBUPRENORPHINE; TELAPREVIR;

ABDOMINAL DISCOMFORT; ADULT; AREA UNDER THE CURVE; ARTICLE; AXILLARY PAIN; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ERUPTION; DRUG INDUCED HEADACHE; ECZEMA; FEMALE; FLUSHING; HUMAN; HUMAN EXPERIMENT; HYPERHIDROSIS; MAINTENANCE THERAPY; MALE; MONOTHERAPY; NAUSEA; OPEN STUDY; PAIN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; TOOTH PAIN; WITHDRAWAL SYNDROME;

ADOLESCENT; ADULT; BUPRENORPHINE; DRUG INTERACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NALOXONE; OLIGOPEPTIDES; YOUNG ADULT;

EID: 84862535415     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00077-12     Document Type: Article

References (20)

1. Chang Y, Moody D, McCance-Katz E. 2006. Novel metabolites of buprenorphine in human liver microsomes and human liver. Drug Metab. Dispos. 34:440-448.
2. Cone EJ, Gorodetzky CW, Yousefnejad D, Buchwald WF, Johnson RE. 1984. The metabolism and excretion of buprenorphine in humans. Drug Metab. Dispos. 12:577-581.
3. Escher M, et al. 2007. Pharmacokinetic and pharmacodynamic properties of buprenorphine after a single intravenous administration in healthy volunteers: a randomized, double-blind, placebo-controlled, crossover study. Clin. Ther. 29:1620-1631.
4. FDA CDER and CBER. 2006. Draft guidance for industry. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. U.S. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Rockville, MD. http://www.abclabs.com/Portals/0/FDAGuidance-DraftDrugInteractionStudies2006. pdf.
5. Franken IH, Hendriksa VM, Van den Brink W. 2002. Initial validation of two opiate craving questionnaires: the Obsessive Compulsive Drug Use Scale and the Desires for Drug questionnaire. Addict. Behav. 27:675-685.
6. Garg V, et al. 2011. The effect of telaprevir on the pharmacokinetics of midazolam and digoxin. J. Clin. Pharmacol. doi:10.1177/0091270011419850.
7. Garg V, et al. 2011. The pharmacokinetic interaction between an oral contraceptive containing ethinyl estradiol and norethindrone and the HCV protease inhibitor telaprevir. J. Clin. Pharmacol. doi:10.1177/0091270011419855.
8. Janssen Pharmaceuticals. 2012. INCIVO. EU summary of product characteristics. Janssen Pharmceuticals, Beerse, Belgium.
9. Jensen ML, et al. 2008. Pharmacokinetic-pharmacodynamic relationships of cognitive and psychomotor effects of intravenous buprenorphine infusion in human volunteers. Basic Clin. Pharmacol. Toxicol. 103:94-101.
10. Lin C, Kwong AD, Perni RB. 2006. Discovery and development of VX-950, a novel, covalent, and reversible inhibitor of hepatitis C virus NS3.4A serine protease. Infect. Disord. Drug Targets 6:3-16.
11. McCance-Katz EF, et al. 2006. Interactions between buprenorphine and antiretrovirals. I. The nonnucleoside reverse transcriptase inhibitors efavirenz and delavirdine. Clin. Infect. Dis. 43(Suppl. 4):S224-S234.
12. Mitsubishi Tanabe Pharmaceuticals. 2011. TELAVIC. Press release. Mitsubishi Tanabe Pharmaceuticals, Osaka, Japan.
13. Picard N, Cresteil T, Djebli N, Marquet P. 2005. In vitro metabolism study of buprenorphine: evidence for new metabolic pathways. Drug Metab. Dispos. 33:689-695.
14. Reckitt Benckiser Pharmaceuticals, Inc. 2012. Suboxone. U.S. package insert. Reckitt Benckiser Pharmaceuticals, Inc., Richmond, VA.
15. Sekar V, et al. 2011. Pharmacokinetic interactions between darunavir/ ritonavir and opioid maintenance therapy using methadone or buprenorphine/ naloxone. J. Clin. Pharmacol. 51:271-278.
16. Tompkins DA, et al. 2009. Concurrent validation of the Clinical Opiate Withdrawal Scale (COWS) and single-item indices against the Clinical Institute Narcotic Assessment (CINA) opioid withdrawal instrument. Drug Alcohol Depend. 105:154-159.
17. van Heeswijk R, et al. 2011. The pharmacokinetic (PK) interaction between darunavir/ritonavir (DRV/r) and fosamprenavir/ritonavir (fAPV/r) and the investigational HCV protease inhibitor telaprevir in healthy volunteers, poster 957. 18th Conf. Retrovir. Opportunistic Infect., Boston, MA, 27 February 27 to 2 March 2011. CROI, Alexandria, VA.
18. Vertex Pharmaceuticals, Inc. 2012. INCIVEK. U.S. package insert. Vertex Pharmaceuticals Inc., Cambridge, MA.
19. Vertex Pharmaceuticals, Inc. 2011. INCIVEK. Canada product monograph. Vertex Pharmaceuticals Inc., Laval, Quebec, Canada.
20. Wesson DR, Ling W. 2003. The Clinical Opiate Withdrawal Scale (COWS). J. Psychoact. Drugs 35:253-259.