Ombitasvir/Paritaprevir/Ritonavir + Omeprazole = Precautionary

Effect on Concentration

Ombitasvir/Paritaprevir/Ritonavir
No change
Applies within class?
No
Omeprazole
Decrease
Applies within class?
No

Pharmacologic Effects

Ombitasvir/Paritaprevir/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

Per the author's recommendations, no dose adjustment is required at this time unless it is clinically indicated for the patient (ie: patient is not responding to omeprazole therapy). Close monitoring for omeprazole efficacy is warranted due to significant decreases in exposure and wide confidence intervals, when coadministered with the 2D regimen.

Sources

Ombitasvir/Paritaprevir/Ritonavir vs Omeprazole ^

Study Design

Eight one sequence crossover, drug-drug interaction studies were conducted to assess the impact on PK values for the 2D regimen, Ombitasvir (25mg daily) + Paritaprevir/Ritonavir (150/100mg).These studies were conducted in healthy volunteers aged 18 to 55 years of age. A total of 12 participants were included in the evaluation of Ketoconazole vs. 2D Regimen.The 2D regimen was administered alone on Day 1. This was followed by a washout period on Days 2 through 7. On Days 8 and 9, Ketoconazole (400mg QD) was administed alone. On Day 10, the 2D regimen was administered with Ketoconazole. On Days 11 through 13, Ketoconazole was administered alone.

Study Results

DrugCmax GMR (90% CI)AUC GMR (90% CI)Ombitasvir0.96 (0.81-1.14)1.00 (0.88-1.12)Paritaprevir1.02 (0.64-1.62)0.93 (0.64-1.34)Ritonavir1.06 (0.95-1.18)1.07 (0.96-1.21)Omeprazole0.48 (0.29-0.78)0.46 (0.27-0.77)Based on the results provided, co-administration of Omeprazole and the 2D regimen causes a significant decrease in Omeprazole Cmax and AUC. It is unknown at this time whether or not this interaction is clinically significant.

Study Conclusions

References

P Badri, S Dutta, H Wang, et al. Drug interactions with direct acting antiviral combination of paritaprevir/ritonavir ombitasvir. 16th International Workshop On Clinical Pharmacology Of Hiv ; Hepatitis Therapy. Washington, DC. ; 2015.