Boceprevir + Digoxin = Precautionary

Effect on Concentration

Boceprevir
Unknown
Applies within class?
No
Digoxin
Increase
Applies within class?
No

Pharmacologic Effects

Boceprevir
Effect
N/A
Applies within class?
No
Digoxin
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

The investigators concluded that no dose adjustment would be necessary for digoxin when coadministered with BOC, but routine monitoring of digoxin levels is recommended.

Sources

Digoxin vs boceprevir ^

Study Design

In an open-label, randomized cross-over study, 16 healthy subjects with age of 19-55 years old received a single dose of digoxin 0.25mg on Day 1 (period 1). After a 10-day washout, subjects received boceprevir (BOC) 800mg three times daily for 10 days (Days 1-10; period 2) with a single dose digoxin 0.25mg on Day 6. Samples for digoxin were taken pre-dose and at specified time points for 120 hours post-dose.

Study Results

Coadministration of BOC and digoxin slightly increased exposure and plasma concentration of digoxin; the geometric mean ratios (GMRs; BOC + digoxin / digoxin) [90% CI] of AUC and Cmax for digoxin were 1.19 [1.12,1.27] and 1.18 [1.07, 1.31], respectively. The investigators concluded these changes as not clinically relevant.

Study Conclusions

References

P Jumes, Feng HP, Xuan FJ, et al. Pharmacokinetic interactions between the hcv protease inhibitor boceprevir and digoxin in healthy adult volunteers [abstract pk_05]. 7th Annual International Workshop On Clinical Pharmacology Of Hepatitis Therapy,june. Cambridge, MA. ; 2012.