Ombitasvir/Paritaprevir/Ritonavir + Warfarin = Unknown or no reaction

Effect on Concentration

Ombitasvir/Paritaprevir/Ritonavir
No change
Applies within class?
No
Warfarin
No change
Applies within class?
No

Pharmacologic Effects

Ombitasvir/Paritaprevir/Ritonavir
Effect
N/A
Applies within class?
No
Warfarin
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. Routine INR monitoring is recommended.

Sources

Ombitasvir/Paritaprevir/Ritonavir vs Warfarin ^

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)Ombitasvir1.03 (0.95-1.11)1.05 (0.99-1.11)Paritaprevir1.15 (0.86-1.54)1.11 (0.94-1.31)Ritonavir1.02 (0.86-1.21)1.00 (0.89-1.12)R-Warfarin0.96 (0.88-1.05)0.87 (0.82-0.91)S-Warfarin0.90 (0.82-0.99)0.85 (0.78-0.95)Co-administration of Wafarin and the 2D regimen did not result in a clinically significant change in the PK values of any agent.

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.