TABLE 5

Predictions for clinical DDI studies using basic and mechanistic static models

Perpetrator DrugObserved AUCR (90% CI)Predicted AUCR
R3 Averagea (Individualb)AUCR Averagea (Individualb)AUCR′c Averagea (Individualb)
ASV (200 mg twice a day)0.71 (0.67–0.75)0.32 (0.26; 0.31; 0.52)2.36 (2.29; 2.37; 2.46)0.50 (0.35; 0.54; 0.83)
ASV (600 mg twice a day)0.56 (0.50–0.64)0.24 (0.18; 0.24; 0.43)3.02 (2.94; 3.01; 3.16)0.70 (0.51; 0.75; 1.09)
DCV (60 mg every day)0.87 (0.83–0.92)0.18 (0.13; 0.17; 0.32)0.43 (0.33; 0.44; 0.68)g
BCV (150 mg twice a day)0.50 (0.45–0.57)0.17 (0.10; 0.26; 0.31)0.53 (0.34; 0.70; 0.72)g
BCV (300 mg twice a day)0.44 (0.40–0.48)0.14 (0.08; 0.23; 0.27)0.55 (0.34; 0.75; 0.77)g
Triple Combination Id0.53 (0.47–0.60)0.084 (0.06; 0.17)1.94 (1.70; 2.12)0.33 (0.21; 0.59)
Triple Combination IIe0.42 (0.37–0.48)0.078 (0.05; 0.16)1.73 (1.45; 1.94)0.32 (0.19; 0.58)
  • CI, confidence interval.

  • a Model prediction using the average values of EC50 and Emax from Table 3.

  • b Model prediction using the EC50 and Emax of individual donors from Table 2.

  • c Mechanistic static model approach not including the TDI effect of ASV.

  • d ASV (200 mg twice a day); DCV (30 mg twice a day); and BCV (75 mg twice a day).

  • e ASV (200 mg twice a day); DCV (30 mg twice a day); and BCV (150 mg twice a day).

  • g Study did not involve ASV, thus AUCR' value is not applicable.