TMC647055 + Simeprevir = Precautionary

Effect on Concentration

TMC647055
Decrease
Applies within class?
No
Simeprevir
Decrease
Applies within class?
No

Pharmacologic Effects

TMC647055
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

Close monitoring of anti-viral activity is warranteduntil more data becomes availablewhen these agents are coadministered, due to the decreased exposures of both drugs.

Sources

Simeprevir vs TMC647055 ^

Study Design

8 HCV-infected patients (7 genotype 1a, 1 genotype 1b) who were treatment-naive or prior-relapsers to a pegylated interferon with ribavirin (PEG-IFN/RBV) regimen received TMC647055 1000mg twice daily and simeprevir 150mg once daily for 10 days.

Study Results

Coadministration of TMC647055 and simeprevir resulted in decrease of exposure for both drugs. AUC12of TMC647055 andAUC24of simeprevir were decreased by 77% and 74%, respectively, on Day 10 as compared to Day 1. TMC647055 exposure (Cmax and AUC12) was increased by simeprevir, both on Day 1 (65% and 85%, respectively) and Day 6 (45% and 87%, respectively), compared to intake of TMC647055 alone.The investigators indicated that coadministration of TMC647055 and simeprevir showed increased antiviral activity compared with TMC647055 or simeprevir alone.

Study Conclusions

References

S Bourgeois, Reesink HW, J Leempoels, et al. Combination therapy of tmc647055 with simeprevir (tmc435) in chronic hepatitis c patients [abstract 1188]. 48th Annual Meeting Of The European Association For The Study Of The Liver (easl). Amsterdam. ; 2013.