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

Effect on Concentration

Applies within class?
No
Doluxetine
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 there is also no dose adjustment required for co-administration of the 2D regimen with fluoxetine, paroxetine, or desipramine. However, those PK interactions have not yet 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)ombitasvir1.04 (0.92-1.16)1.04 (1.00-1.09)paritaprevir1.07 (0.63-1.81)0.96 (0.70-1.32)ritonavir1.05 (0.78-1.42)1.10 (0.93-1.31)duloxetine0.83 (0.72-0.96)0.80 (0.71-0.90)No clinically significant changes in PK were reported. The authors state that duloxetine 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.