TABLE 2.
Everolimus pharmacokinetic parameters
| Parameter | Everolimus 0.75 mg Period 1 Day 1 (N = 12) | Everolimus 0.75 mg +3D regimen Period 2 Day 15 (N = 12) | |
|---|---|---|---|
| Geometric mean (Geometric %CV) | Geometric mean (Geometric %CV) | Geometric mean ratio (90% CI) | |
| Cmax (ng/ml) | 3.33 (31) | 15.8 (19) | 4.74 (4.29–5.25) c |
| AUCinf (ng•h/ml) | 41.9 (31) | 1130 (19) | 27.1 (24.5–30.1) c |
| C12 (ng/ml) | 0.513 (31) | 8.26 (18) | 16.1 (14.5–17.9) c |
| Tmax (h) a | 2.0 (1.5–2.5) | 3.0 (2.0–4.0) | – |
| t 1/2 (h) b | 42.4 (7) | 118 (18) | – |
Note: 3D regimen: ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD plus dasabuvir 250 mg BID.
Abbreviations: AUCinf, area under the blood concentration‐time curve from time zero to infinite time; C12, blood concentration 12 h after dose; CI, confidence interval; Cmax, maximum observed blood concentration; CV, coefficient of variation; Tmax, time to maximum observed blood concentration; t 1/2, terminal phase elimination half‐life.
a
Median (range).
b
Harmonic mean (pseudo‐standard deviation).
c
p < .0001 based on the repeated measures analysis on the natural logarithms of PK parameters.