The effect of multiple doses of peginterferon alfa-2b on the steady-state pharmacokinetics of methadone in patients with chronic hepatitis C undergoing methadone maintenance therapy

Journal of Clinical Pharmacology

Volumn 47, Issue 5, 2007, Pages 604-612

  Gupta, Samir K ^a   Sellers, Edward ^b   Somoza, Eugene ^c   Angles, Luis ^d   Kolz, Karen ^a   Cutler, David L ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Ventana Clinical Research Corporation   (Canada)

^c Cincinnati Addictions Research Center CinARC   (United States)

^d Heart of America Research   (United States)

Author keywords

Drug interactions; Hepatitis C; Methadone; Peginterferon alfa 2b; Pharmacokinetics

Indexed keywords

METHADONE; PARACETAMOL; PEGINTERFERON ALPHA2B;

ABDOMINAL PAIN; ADULT; ANOREXIA; ANXIETY; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BIOEQUIVALENCE; BLOOD SAMPLING; BLURRED VISION; CLINICAL ARTICLE; CLINICAL TRIAL; COLD SENSATION; CONFIDENCE INTERVAL; CONFUSION; DEPRESSION; DOSE RESPONSE; DRUG DEPENDENCE; DRUG EFFECT; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEPATITIS C; HERPES SIMPLEX; HOT FLUSH; HUMAN; HYPERHIDROSIS; HYPERTRIGLYCERIDEMIA; HYPESTHESIA; INJECTION SITE CONTUSION; INJECTION SITE INFLAMMATION; INJECTION SITE REACTION; INSOMNIA; INTRAVENOUS DRUG ABUSE; IRRITABILITY; LEUKOPENIA; MAINTENANCE THERAPY; MALE; MAXIMUM PLASMA CONCENTRATION; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPENIA; REPEATED DRUG DOSE; RETCHING; RHINORRHEA; RIGOR; SIDE EFFECT; SOMNOLENCE; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; TREMOR; VOMITING; WEAKNESS; WITHDRAWAL SYNDROME;

ADULT; ANALGESICS, OPIOID; ANTIVIRAL AGENTS; DRUG INTERACTIONS; FEMALE; HEPATITIS C, CHRONIC; HEROIN DEPENDENCE; HUMANS; INTERFERON ALFA-2B; MALE; METHADONE; MIDDLE AGED; NARCOTICS;

EID: 34247397958     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007299760     Document Type: Article

References (36)

1. Sulkowski MS, Thomas DL Epidemiology and natural history of hepatitis C virus infection in injection drug users: implications for treatment. Clin Infect Dis. 2005 ; 40 (suppl 5). S263 - S269.
2. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998 ; 47: 1-39.
3. Wang CQ, Li Y., Douglas SD, et al. Morphine withdrawal enhances hepatitis C virus replicon expression. Am J Pathol. 2005 ; 167: 1333-1340.
4. Stephenson J. Former addicts face barriers to treatment for HCV. JAMA. 2001 ; 285: 1003-1005.
5. National Institutes of Health. Management of hepatitis C: 2002. Available at: http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm. Accessed March 20, 2006.
6. Edlin BR, Kresina TF, Raymond DB, et al. Overcoming barriers to prevention, care, and treatment of hepatitis C in illicit drug users. Clin Infect Dis. 2005 ; 40 (suppl 5). S276 - S285.
7. McCaffrey BR Methadone treatment: our vision for the future. J Addict Dis. 2001 ; 20: 93-101.
8. O'Connor PG, Fiellin DA Pharmacologic treatment of heroin-dependent patients. Ann Intern Med. 2000 ; 133: 40-54.
9. Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 ; 343: 1290-1297.
10. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 ; 358: 958-965.
11. Bruno S., Camma C., Di Marco V, et al. Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C: a randomized controlled trial. J Hepatol. 2004 ; 41: 474-481.
12. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 ; 347: 975-982.
13. Pockros PJ, Carithers R., Desmond P., et al. Efficacy and safety of two-dose regimens of peginterferon alpha-2a compared with interferon alpha-2a in chronic hepatitis C: a multicenter, randomized controlled trial. Am J Gastroenterol. 2004 ; 99: 1298-1305.
14. Hadziyannis SJ, Sette H. Jr, Morgan TR, et al. Peginterferon-a2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 ; 140: 346-355.
15. Inturrisi CE Pharmacology of methadone and its isomers. Minerva Anestesiol. 2005 ; 71: 435-437.
16. Ferrari A., Coccia Cpr, Bertolini A., Sternieri E. Methadone: metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004 ; 50: 551-559.
17. Kharasch ED, Hoffer C., Whittington D., Sheffels P. Role of hepatic and intestinal cytochrome P450 3A and 2B6 in the metabolism, disposition, and miotic effects of methadone. Clin Pharmacol Ther. 2004 ; 76: 250-269.
18. Becquemont L., Chazouilleres O., Serfaty L., et al. Effect of interferon alpha-ribavirin bitherapy on cytochrome P450 1A2 and 2D6 and N-acetyltransferase-2 activities in patients with chronic active hepatitis C. Clin Pharmacol Ther. 2002 ; 71: 488-495.
19. Pageaux GP, le Bricquir Y., Berthou F., et al. Effects of interferon-alpha on cytochrome P-450 isoforms 1A2 and 3A activities in patients with chronic hepatitis C. Eur J Gastroenterol Hepatol. 1998 ; 10: 491-495.
20. Islam M., Frye RF, Richards TJ, et al. Differential effect of IFNa-2b on the cytochrome P450 enzyme system: a potential basis of IFN toxicity and its modulation by other drugs. Clin Cancer Res. 2002 ; 8: 2480-2487.
21. The effects of PEGInterferon alfa-2b on drug metabolizing enzymes in man (study report for protocol no. I97-078). Kenilworth, NJ: Schering-Plough Research Institute ; 1998. Doc ID 98349050. SCH 54031.
22. Hoofnagle JH Course and outcome of hepatitis C. Hepatology. 2002 ; 36: S21 - S29.
23. Dienstag JL, McHutchison JG American Gastroenterological Association technical review on the management of hepatitis C. Gastroenterology. 2006 ; 130: 231-264.
24. Eap CB, Buclin T., Baumann P. Interindividual variability of the clinical pharmacokinetics of methadone: implications for the treatment of opioid dependence. Clin Pharmacokinet. 2002 ; 41: 1153-1193.
25. Gibaldi M., Perrier D. Pharmacokinetics. 2 nd ed. New York: Marcel Dekker ; 1982.
26. Glue P., Rouzier-Panis R., Raffanel C., et al. A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. Hepatology. 2000 ; 32: 647-653.
27. Liang HR, Foltz RL, Meng M., Bennett P. Method development and validation for quantitative determination of methadone enantiomers in human plasma by liquid chromatography/tandem mass spectrometry. J Chromatogr B. 2004 ; 806: 191-198.
28. Food and Drug Administration. Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling. Rockville, Md: Food and Drug Administration ; 2006.
29. Glue P., Fang JW, Rouzier-Panis R., et al. Pegylated interferon-alpha2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data. Clin Pharmacol Ther. 2000 ; 68: 556-567.
30. Fried MW Side effects of therapy of hepatitis C and their management. Hepatology. 2002 ; 36 (suppl 1). S237 - S244.
31. Huber M., Weber R., Oppliger R., et al. Interferon alpha-2a plus ribavirin 1,000/1,200 mg versus interferon alpha-2a plus ribavirin 600 mg for chronic hepatitis C infection in patients on opiate maintenance treatment: an open-label randomized multicenter trial. Infection. 2005 ; 33: 25-29.
32. Mauss S., Berger F., Goelz J., Jacob B., Schmutz G. A prospective controlled study of interferon-based therapy of chronic hepatitis C in patients on methadone maintenance. Hepatology. 2004 ; 40: 120-124.
33. Van Thiel DH, Anantharaju A., Creech S. Response to treatment of hepatitis C in individuals with a recent history of intravenous drug abuse. Am J Gastroenterol. 2003 ; 98: 2281-2288.
34. Neri S., Bruno CM, Abate G., et al. Controlled clinical trial to assess the response of recent heroin abusers with chronic hepatitis C virus infection to treatment with interferon alpha-n2b. Clin Ther. 2002 ; 24: 1627-1635.
35. Garrido MJ, Troconiz IF Methadone: a review of its pharmacokinetic/ pharmacodynamic properties. J Pharmacol Toxicol Methods. 1999 ; 42: 61-66.
36. Lotsch J., Skarke C., Liefhold J., Geisslinger G. Genetic predictors of the clinical response to opioid analgesics: clinical utility and future perspectives. Clin Pharmacokinet. 2004 ; 43: 983-1013.