Coadministration of GZR/EBR with PAN had no clinically relevant effect on the PK of GZR or EBR. Investigators concluded that that PAN may be coadministered with the GZR/EBR in HCV-infected patients without restriction.
Elbasvir/grazoprevir vs famotidine or pantoprazole
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Study Design
In an open-label, 3-period, fixed-sequence study, 16 healthy adultsubjects received famotidine (FAM) 20 mg approximately 10 hours (Day -1) and 2 hours (Day 1) prior to administration of GZR/EBR 100/50 mg on Day 1 (Period 1). In Period 2, subjects received a single dose of Grazoprevir/Elbasvir(GZR/EBR 100/50 mg) on Day 1 in the fasted state, approximately 2 hours after FAM dosing.After at least 10-day washout, subjects received pantoprazole (PAN) 40 mg once daily for 5 days (Days 1 to 5) followed by administration of GZR/EBR 100/50 mg, 2 hours after PAN administration on Day 5 (Period 3).
Study Results
Coadministration of GZR/EBR (100/50 mg) with PAN (40 mg) resulted in no significant effect on pharmacokinetics (PK) parameters of either GZR or EBR.The geometric mean ratios (GMRs; GZR/EBR + PAN / GZR/EBR) [90% CIs] of GZR were: 1.10 [0.89, 1.37] for Cmax, 1.12 [0.96, 1.30] for AUC, 1.17 [1.02, 1.34] for C24GMRs (GZR/EBR + PAN / GMR/EBR) [90% CIs] of EBR were: 1.02 [0.92, 1.14] for Cmax, 1.05 [0.93, 1.18] for AUC, 1.03 [0.92, 1.17] for C24The effect of GZR/EBR on the PK of PAN was not reported.
References
Feng HP, P Auger, P Vaddady, et al. Pharmacokinetic interaction between hcv inhibitors grazoprevir/elbasvir with famotidine and pantoprazole. 66th Annual Meeting Of The American Association For The Study Of Liver Diseases (aasld). San Francisco, CA. ; 2015.
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