Simeprevir + Rosuvastatin = Precautionary

Effect on Concentration

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

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Simeprevir versus Rosuvstatin ^

Study Design

Interactions between rosuvastatin and simeprevir were evaluated in 16 healthy subjects (10 male) in a randomized, open-label, two-period crossover study with a washout period of at least 14 days (data on ?le). Subjects received rosuvastatin alone (10 mg single dose) or simeprevir (150 mg once daily on days 1–7) plus rosuvastatin (10 mg single dose on day 7) under fed conditions.

Study Results

With simeprevir coadministration, the mean Cmax and AUC24h of rosuvastatin were increased by 3.17- and 2.81-fold, respectively, in comparison with administration of rosuvastatin alone Drug Effect on PK PK Parameters Cmax AUC Cmin Simeprevir NA NA NA NA Rosuvastatin Increase 3.17 (2.57 – 3.91 2.81 (2.34 – 3.37) NA

Study Conclusions

The authors concluded that like the other statin drugs, rosuvastatin should be titrated to the lowest possible dose, with close safety monitoring when it is used in combination 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.