Daclatasvir + Simeprevir = Precautionary

Effect on Concentration

Daclatasvir
Increase
Applies within class?
No
Simeprevir
Increase
Applies within class?
No

Pharmacologic Effects

Daclatasvir
Effect
N/A
Applies within class?
No
Simeprevir
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

No dose adjustment of daclatasvir or simeprevir is required

Sources

Daclatasvir vs Simeprevir ^

Study Design

Drug-drug interactions with simeprevir were evaluated in a two-panel, randomized, open-label, twoperiod crossover study with a washout period of 7 days between study periods. Nineteen healthy subjects (18 male) received daclatasvir (60 mg once daily) or daclatasvir (60 mg once daily) plus simeprevir (150 mg once daily) for 7 days, and 25 healthy subjects (20 male) received simeprevir (150 mg once daily) or simeprevir (150 mg once daily) plus daclatasvir (60 mg once daily) for 7 days; all treatments were administered under fed conditions.

Study Results

The mean Cmax and AUC24h of daclatasvir were increased by 1.50- and 1.96-fold, respectively, with coadministration in comparison with daclatasvir alone. The mean Cmax and AUC24h of simeprevir were increased by 1.39- and 1.44-fold, respectively.

Study Conclusions

References

Sivi Ouwerkerk-Mahadevan, Jan Snoeys, Monika Peeters, Maria Beumont-Mauviel, Alexandru Simion. Drugdrug interactions with the ns3/4a protease inhibitor simeprevir. Clinical Pharmacokinetics. 2016; 2: 197-208.