Grazoprevir (Single Agent) + Tenofovir Disoproxil Fumarate = Unknown or no reaction

Effect on Concentration

Applies within class?
No
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

Sources

Study Design

An open-label, multiple-dose study was conducted to assess the effects of Raltegravir (RAL) on the pharmacokinetics of Grazoprevir (GZR). Participants were healthy adults aged 19 to 55 years old.During Period 1 of the study, 11 participants received RAL (400mg) dosed twice daily on days 1 through 4.After an 8 day washout after Period 1, participants then received GZR (200mg) daily on days 1 through 7 of Period 2.During Period 3, participants received GZR (200mg) dosed daily in addition to RAL (400mg) dosed twice daily on days 1 through 7.

Study Results

DrugAUC GMR (90% CI)Cmax GMR (90% CI)C24h (90% CI)TDF1.18 (1.09-1.28)1.14 (1.04-1.25)1.24 (1.10-1.39)GZR0.86 (0.65-1.12)0.78 (0.51-1.18)0.89 (0.78-1.01)Based on the PK data, coadministration of TDF and GZR showed no clinically significant changes in PK values of either agent. There are no dose adjustments warranted at this time.

Study Conclusions

References

Yeh WW, Fraser IP, L Caro, et al. No meaningful pk interaction between hcv protease inhibitor mk-5172 and tenofovir or raltegravir. Conference On Retroviruses And Opportunistic Infections. Boston, Massachusetts. ; 2014.