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

Effect on Concentration

Applies within class?
No
Escitalopram
Decrease
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 22-Nov-2022

Summary

** Based on these data, the authors state that no dose adjustments are required when the 2D regimen is co-administered with citalopram. However this PK interaction has not been formerly studied.

Sources

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)Ombitasvir1.16 (1.09-1.23)1.03 (1.00-1.06)Paritaprevir1.19 (0.84-1.68)1.02 (0.82-1.27)Ritonavir1.38 (1.15-1.66)1.25 (1.07-1.46)Escitalopram0.92 (0.85-0.99)0.75 (0.67-0.84)No clinically significant changes in PK parameters were reported. The authors state that escitalopram and the 2D regimen may be co-administered without any dose adjustments.

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.