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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.
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.
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.