Elbasvir/Grazoprevir + Prednisone = Unknown or no reaction

Effect on Concentration

Elbasvir/Grazoprevir
No change
Applies within class?
No
Prednisone
No change
Applies within class?
No

Pharmacologic Effects

Elbasvir/Grazoprevir
Effect
N/A
Applies within class?
No
Prednisone
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

There wereno clinically relevant drug interactions found between GZR/EBR and prednisone in healthy subjects.

Sources

Grazoprevir/elbasvir vs tacrolimus, mycophenolate mofetil, prednisone, or cyclosprine ^

Study Design

This was a 4-part, open label, mulitple site study. Each part consisted of 2 periods with a fixed sequence design. In Part 2, the pharmacokinetic (PK) interaction potential between grazoprevir/elbasvir (GZR/EBR) and tacrolimus (TAC) was studied.16 healthy adults were given a single dose of TAC 2mg on Day 1 (Period 1). After a 6-day washout, subjects took GZR/EBR 200/50mg once daily for 16 days, with administration of TAC 2mg on Day 11 in Period 2.

Study Results

When subjects were given prednisone with GZR/EBR, prednisone had no significant effect on pharmacokinetic (PK) parameters of either GZR or EBR.The geometric mean ratios (GMRs; GZR/EBR + prednisone / GZR/EBR) [90% CIs] of GZR were 1.09 [0.95, 1.25] for AUC, 1.34 [1.10, 1.62] for Cmax and 0.93 [0.87, 1.00] for C24.GMRs (GZR/EBR + prednisone / GZR/EBR) [90% CIs] of EBR were 1.17 [1.11, 1.24] for AUC, 1.25 [1.16, 1.35] for Cmax and 1.04 [0.97, 1.12] for C24.Investigators concluded that GZR/EBR did not significantly affect the pharmacokinetics (PK) of either prednisone or prednisolone. GMRs (GZR/EBR + prednisone / prednisone) [90% CIs] of prednisone were 1.08 [1.00,1.17] for AUC and 1.05 [1.00, 1.10] for Cmax.GMRs (GZR/EBR + prednisone / prednisone) [90% CIs] of prednisolone were 1.08 [1.01,1.16] for AUC and 1.04 [0.99, 1.09]for Cmax.

Study Conclusions

References

Yeh WW, H Feng, L Caro, et al. Clinically meaningful pharmacokinetic interactions between hcv inhibitors grazoprevir/elbasvir with tacrolimus, mycophenolate mofetil, and prednisone, but cyclosprine increases grazoprevir/elbasvir ex. 66th Annual Meeting Of The American Association For The Study Of Liver Diseases (aasld). San Francisco, CA. ; 2015.