J Clin Pharmacol
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First published on March 30, 2007, doi:10.1177/0091270007299760

The Journal of Clinical Pharmacology 2007;47:604.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007299760

Article

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

Samir K. Gupta 1*, Edward Sellers 2, Eugene Somoza 3, Luis Angles 4, Karen Kolz 1, and David L. Cutler 1

1 Schering-Plough Research Institute, Kenilworth, New Jersey
2 Ventana Clinical Research Corporation, Toronto, Canada
3 Cincinnati Addiction Research Center, Cincinnati, Ohio
4 Heart of America Research, Shawnee Mission, Kansas

* To whom correspondence should be addressed. E-mail: samir.gupta{at}spcorp.com.


  Abstract
This multicenter, open-label study evaluated the effects of multiple doses of peginterferon alfa-2b on the steady-state pharmacokinetics of methadone in 20 adults with hepatitis C virus infection who were enrolled in a methadone maintenance program. All subjects received peginterferon alfa-2b 1.5 µg/kg/wk for 4 weeks and maintained their normal methadone regimen. Serial blood samples were collected immediately before the first and after the fourth peginterferon alfa-2b dose (day 23). At day 23, exposure to the active methadone R-enantiomer increased by approximately 15% following administration of peginterferon alfa-2b, with 90% confidence intervals just outside the bioequivalence criteria (range, 80%-125%). Similar increases in exposure (Cmax, AUC0-24, and AUClast) were observed with S-methadone and total methadone. Peginterferon alfa-2b was well tolerated. Peginterferon alfa-2b is associated with minor increases in exposure to methadone in individuals with hepatitis C virus infection; however, these increases are unlikely to be clinically meaningful and are not associated with any safety concerns.
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