Simeprevir + Atorvastatin = Precautionary

Effect on Concentration

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

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Simeprevir versus Atorvastatin ^

Study Design

In a randomized, open-label, two-panel study, 36 healthy subjects (26 male) received atorvastatin (40 mg single doses on days 1 and 13) plus simeprevir (150 mg once daily on days 4–15) under fed conditions.

Study Results

There were no clinically relevant changes in the pharmacokinetics of simeprevir with coadministration of atorvastatin. . However, the Cmax and the AUC from time zero to in?nity (AUC?) of atorvastatin were increased by 1.70- and 2.12-fold, respectively, with coadministration in comparison with atorvastatin administered alone. Drug Effect on PK PK Parameters Cmax AUC Cmin Simeprevir No change Data on File Atorvastatin Increase 1.70 (1.42 – 2.04) 2.12 (1.72 – 2.62) NA

Study Conclusions

The authors concluded that while there were no clinically relevant changes in simeprevir, coadministration with atorvastatin increased atorvastatin pharmacokinetic parameters. Use the lowest necessary dose of atorvastatin, but do not exceed a daily dose of atorvastatin 40 mg when it is coadministered with simeprevir.

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.