J Clin Pharmacol
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DRUG INTERACTIONS

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, PhD, Edward Sellers, MD, PhD, Eugene Somoza, MD, PhD, Luis Angles, MD, Karen Kolz, MS and David L. Cutler, MD, FRCP(C)

From Schering-Plough Research Institute, Kenilworth, New Jersey (Dr Gupta, Dr Kolz, Dr Cutler); Ventana Clinical Research Corporation, Toronto, Canada (Dr Sellers); Cincinnati Addiction Research Center, Cincinnati, Ohio (Dr Somoza); and Heart of America Research, Shawnee Mission, Kansas (Dr Angles).

This multicenter, open-label study evaluated the effects of multiple doses of peginterferon alfa-2b on the steadystate 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.

Key Words: Drug interactions • hepatitis C • methadone • peginterferon alfa-2b • pharmacokinetics

Address for reprints: Address for correspondence: Samir K. Gupta, PhD, MBA, Schering-Plough Research Institute K15-22745, 2015 Galloping Hill Road, Kenilworth, NJ 07033; e-mail: samir.gupta{at}spcorp.com.




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[Abstract] [Full Text] [PDF]


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