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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
Author(s) -
Gupta Samir K.,
Sellers Edward,
Somoza Eugene,
Angles Luis,
Kolz Karen,
Cutler David L.
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270007299760
Subject(s) - methadone , medicine , pharmacokinetics , bioequivalence , hepatitis c , methadone maintenance , regimen , pharmacology , gastroenterology , anesthesia
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 (C max , AUC 0–24 , and AUC last ) 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.