The authors state that TAC may be co-administered with GZR+EBR. Close monitoring of TAC levels may be warranted during continuous co-administration of these agents.
Grazoprevir/elbasvir vs tacrolimus, mycophenolate mofetil, prednisone, or cyclosprine
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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
Using geometric mean ratios and 90% confidence intervals (GMR, 90% CI), results showed a 40% increasein AUC forTAC, and a 40% decrease in TAC Cmaxwhen co-administered with GZR/EBR.A single dose of TAC had no significant effect on the multiple-dose PK exposure of GRZ or EBR.PK ParameterGZR/EBR + TAC / TACGMR (90% CI)GZR/EBR + TAC / GZRGMR (90% CI)GZR/EBR + TAC / EBRGMR (90% CI)AUC1.43 [1.24, 1.64]1.12 [0.97, 1.30]0.97 [0.90, 1.06]Cmax0.60 [0.52, 0.69]1.07 [0.83, 1.37]0.99 [0.88, 1.10]Cmin1.70 [1.49, 1.94]0.94 [0.87, 1.02]0.92 [0.83, 1.02]
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.
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