* 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 did not significantly impact the pharmacokinetics (PK) of buprenorphine. Geometric mean ratios (GMRs; BOC + buprenorphine/naloxone / buprenorphine/naloxone) [90% CIs] of AUC, Cmaxand Cmin for buprenorphine were 1.19 [0.91, 1.57], 1.18 [0.93, 1.50] and 1.31 [0.95, 1.79], respectively. Additionally, those for buprenorphine's circluating metabolite, norbuprenorphine, were 0.55 [0.36, 0.86], 0.54 [0.36, 0.83] and 0.68 [0.41, 1.11], respectively.Coadministration of BOC (800 mg three times daily) for 7 days resulted in modest increase of naloxone exposure. GMRs (BOC + buprenorphine/naloxone / buprenorphine/naloxone) [90% CIs] of AUC and Cmaxfor naloxone were 1.33 [0.90, 1.93] and 1.09 [0.79, 1.51], respectively.No symptoms of opiate toxicity or withdrawal were noted.The investigators concluded that BOC may be coadministered with buprenorphine/naloxone without dose adjustment. However, monitor the patient closely as PKs of buprenorphine and naloxone were variably affected when coadministered with BOC.
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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