* In this study, BOC was administered in the absence of peg-interferon and ribavirin, whereas in clinical practice, BOC is co-administered with these agents.
Boceprevir vs opioid maintenance agents
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Study Design
In two-center, open-label, fixed sequence study, 10 hepatitis C virus (HCV)-negative adults with ages 18-65 years on stable opiate maintenance therapy with methadone (20-150 mg daily) received boceprevir (BOC) 800 mg every 8 hours for 7 days. Samples of BOC were collected pre-dose and at specified time points for 24 hours post-dose of BOC.
Study Results
Coadministration of BOC (800 mg three times daily) for 7 days modestly reduced the pharmacokinetics (PK) of both R- (active enantiomer) and S- methadone. Geometric mean ratios (GMRs; BOC+methadone / methadone) [90% CIs] of AUC, Cmaxand Cmin for R-methadone were 0.85 [0.74, 0.96],0.90 [0.71, 1.13] and 0.81 [0.66, 1.00], respectively. GMRs (BOC+methadone / methadone) [90% CIs] of AUC, Cmaxand Cmin for S-methadone were 0.78 [0.66, 0.93], 0.83 [0.64, 1.09] and 0.74 [0.58, 0.95], respectively.The effect of methadone on the PK of BOC was not reported.No symptoms of opiate toxicity or withdrawal were noted.The investigators concluded that BOC may be coadministered with methadone without dose adjustment.
References
Ellen GJ Hulskotte, R Douglas Bruce, Hwa-Ping Feng, Lynn R Webster, Feng Xuan, Wen H Lin, Edward OMara, John A Wagner, Joan R Butterton. Pharmacokinetic interaction between hcv protease inhibitor boceprevir and methadone or buprenorphine in subjects on stable maintenance therapy. Eurpoean Journal Of Clinical Pharmacology. 2015; 3: 303-311.
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