Simeprevir + Digoxin = Precautionary

Effect on Concentration

Simeprevir
No change
Applies within class?
No
Digoxin
Increase
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Simeprevir versus Digoxin ^

Study Design

In a randomized, open-label, two-period crossover study with a washout period of at least 14 days, 16 healthy subjects (13 male) received digoxin (0.25 mg single dose) or simeprevir (150 mg once daily for 7 days) plus digoxin (0.25 mg single dose on day 7) under fed conditions.

Study Results

When digoxin and simeprevir were coadministered, the mean Cmax and AUC24h of digoxin were increased by 1.31- and 1.39-fold, respectively, in comparison with administration of digoxin alone. Drug Effect on PK PK Parameters Cmax AUC Cmin Simeprevir NA NA NA NA Digoxin Increase 1.31 (1.14 – 1.51) 1.39 (1.16 – 1.67) NA

Study Conclusions

Given these results, the authors concluded that if using simeprevir and digoxin together, concentrations of digoxin should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. This is particularly important given the narrow therapeutic index of digoxin.

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.