The investigators from MERCK state that pravastatin may be coadministered with GZR/EBR without dose adjustment. It was also noted that participants tolerated standard-dose pravastatin in phase 2 and 3 trials.
Pravastatin vs grazoprevir/elbasvir
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Study Design
In an open-label study, 24 healthy subjects received a single 40mg dose of pravastatin on Day 1. With no drug washout, subjects then received grazoprevir / elbasvir (GZR/EBR;MK-5172/MK-8742) 200mg/50mg daily for 9 days, together with 40mg of pravastatin on Day 9.
Study Results
Coadministration of GZR/EBR and pravastatin resulted in a 28% increase in both AUC and Cmax of pravastatin; the geometric mean ratios (GMRs; pravavatatin + GZR/EBR / pravastatin) [90% CI] of AUC and Cmax of pravastatin were 1.28 [1.08,1.51] and 1.28 [1.05, 1.55], respectively.The investigators concluded that these changes were not clinically relevant. There was no meaningful effect on the PK of GZR or EBR when coadministered with pravastatin. GMRs; pravavatatin + GZR/EBR / GZR) [90% CI] of AUC, Cmax and C24 of GZR were 1.24 [1.00,1.53], 1.42 [1.00, 2.03] and 1.07 [0.99, 1.16], respectively, while AUC, Cmax and C24 of EBR were 0.98 [0.93,1.02], 0.97 [0.89, 1.05] and 0.97 [0.92, 1.02], respectively.
References
L Caro, W Marshall, H Feng, et al. Coadministration of hcv protease inhibitor grazoprevir with hcv ns5a inhibitor elbasvir has no effect on pravastatin but increases rosuvastatin exposure in healthy subjects. 16th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington, DC. ; 2015.
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