Simeprevir + Omeprazole = Unknown or no reaction

Effect on Concentration

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

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Study Design

The effect of simeprevir on the CYP system was clinically evaluated in a phase I, two-period, open-label, randomized, crossover trial, which utilized five representative CYP probes. In this trial, 16 healthy subjects (five male) received a drug cocktail that included omeprazole 40 mg alone or in combination with 150 mg of simeprevir under fed conditions.

Study Results

Simeprevir coadministration resulted in increased exposure to omeprazole (the Cmax and AUClast increased by 1.14- and 1.21-fold, respectively).

Study Conclusions

Author’s concluded no clinically significant interaction, and no need for dose adjustments

References

V Sekar, R Verloes, P Meyvisch. Evaluation of metabolic interactions for tmc435 via cytochrome p450 (cyp) enzymes in healthy volunteers [poster]. presented at: 45th annual meeting of the european association for the. Study Of The Liver (easl); April. Vienna. ; 1418.