Danoprevir/Ritonavir + Omeprazole = Precautionary

Effect on Concentration

Danoprevir/Ritonavir
Decrease
Applies within class?
No
Omeprazole
Unknown
Applies within class?
No

Pharmacologic Effects

Danoprevir/Ritonavir
Effect
N/A
Applies within class?
No
Omeprazole
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

The investigators concluded that coadministration of DNV/r with omeprazole did not have a clinically relevant effect on DNV pharmacokinetics (PK).

Sources

Danoprevir/r vs antacids ^

Study Design

13 healthy subjects received a single dose of danoprevir/ ritonavir (DNV/r) 100/100 mg on Day 1 (period 1). After a 7-day washout, subjects received a single dose of ranitidine 150mg with a single dose DNV/r 100/100mg 2 hours later on Day 8 (period 2). After a 7-day washout, subjects then received omeprazole 40mg once daily,1 hour before meal, for 5 days (Day 15-19) with a single dose DNV/r 100/100mg on Day 19 (period 3). Samples for DNV/r were collected pre-dose and at specified time points (0.5,1, 2, 3 ,4, 5, 6, 8,12,16 and 24hours) after post-dose of DNV/r.

Study Results

Omeprazole had modest effect on exposure and plasma concentration of DNV; the geometric mean ratios (GMRs; omeprezole + DNV/r / DNV/r) [90% CI] of AUC and Cmax for DNV were 0.83 [0.67, 1.02] and 0.93 [0.71, 1.22], respectively.

Study Conclusions

References

Peter N Morcos, Sebastian A Moreira, Mercidita T Navarro, Nria Bech, Amanda Quatkemeyer, Patrick F Smith, Barbara J Brennan. Effect of meal and antisecretory agents on the pharmacokinetics of danoprevir/ritonavir in healthy volunteers. Journal Of Pharmacy And Pharmacology. 2014; 1: 23-31.