Ledipasvir/Sofosbuvir + Omeprazole = Unknown or no reaction

Effect on Concentration

Ledipasvir/Sofosbuvir
No change
Applies within class?
No
Omeprazole
No change
Applies within class?
No

Pharmacologic Effects

Ledipasvir/Sofosbuvir
Effect
N/A
Applies within class?
No
Omeprazole
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 16-Jul-2018

Summary

Doses of omeprazole should be given on empty stomach and not to exceed 20 mg daily.

Sources

Clinical pharmacokinetics and pharmacodynamics of ledipasvir/sofosbuvir, a fixed-dose combination tablet for the treatment of hepatitis C. Clinical pharmacokinetics, ^

Study Design

The drug-drug interaction potential of ledipasvir/sofosbuvir (LDV/SOF) with omeprazole was assessed. Pharmacokinetic evaluations of single dose LDV/SOF administered as a 90/400mg once daily, and omeprazole given as 20mg were conducted (n=16).

Study Results

Using geometric mean ratios (GMR) and 90% confidence intervals (CI), the Cmax and AUC for SOF, GS-331007 (major circulating metabolite for SOF) and LDV were as follows: SOF: 1.12 (0.88-1.42) and 1.00 (0.80-1.25); GS-331007: 1.14 (1.01-1.29) and 1.03 (0.96-1.12); LDV: 0.89 (0.61-1.30) and 0.96 (0.66-1.39), respectively, with simultaneous co-administration.

Study Conclusions

The manufacturer states that proton pump inhibitors may be administered simultaneously with LDV/SOF under fasted conditions at a dose not exceeding omeprazole 20mg.

References

German P, Mathias A, Brainard D, Kearney BP. Clinical pharmacokinetics and pharmacodynamics of ledipasvir/sofosbuvir, a fixed-dose combination tablet for the treatment of hepatitis c. Clinical Pharmacokinetics. 2016; 11: 1337-1351.