Simeprevir + Methadone = Unknown or no reaction

Effect on Concentration

Simeprevir
No change
Applies within class?
No
Methadone
No change
Applies within class?
No

Pharmacologic Effects

Simeprevir
Effect
N/A
Applies within class?
No
Methadone
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Simeprevir versus Methadone ^

Study Design

In an open-label study, 12 HCVnegative, opioid-dependent subjects (ten male) receiving stable methadone maintenance therapy (between 30 and 150 mg once daily) received simeprevir 150 mg once daily for 7 days.

Study Results

Simeprevir exposure alone could not be measured in this study for comparison. However, the Cmax and AUC24h of simeprevir with coadministration of methadone for 7 days (966 ng/mL and 12,110 ng_h/mL, respectively) were lower than the mean Cmax and AUC24h reported in a pooled analysis of phase I data in which simeprevir 150 mg was administered alone once daily for 7 days (1992 and 22,850 ng/mL); the difference in simeprevir exposure was not considered clinically relevant. The Cmin, Cmax and AUC24h of both methadone enantiomers were unchanged with coadministration of simeprevir in comparison with methadone alone. Drug Effect on PK PK Parameters Cmax AUC Cmin Simeprevir NA NA NA NA Methadone No change 1.03 (0.97 – 1.09) 0.99 (0.91 – 1.09) 1.02 (0.93 – 1.12)

Study Conclusions

The authors concluded that there was no clinically significant drug interaction between simeprevir and methadone, and that these agents may be administered simultaneously without dose adjustment.

References

Ouwerkerk Mahadevan S, Snoeys J, Peeters M, Beaumont Mauviel M, Simion A. Drug–drug interactions with the ns3/4a protease inhibitor simeprevir. Clinical Pharmacokinetics. 2016; 2: 197-208.