TABLE 1.
Sirolimus pharmacokinetic parameters
| Parameter | Sirolimus 2 mg Period 1 Day 1 (N = 11) | Sirolimus 0.5 mg + 3D regimen Period 2 Day 15 (N = 11) | |
|---|---|---|---|
| Geometric mean (Geometric %CV) | Geometric mean (Geometric %CV) | Geometric mean ratio (90% CI) | |
| Cmax/Dose (ng/ml/mg) | 3.33 (33) | 21.3 (7) | 6.40 (5.34–7.68) c |
| AUCinf/Dose (ng•h/ml/mg) | 89.2 (33) | 3390 (8) | 38.0 (31.5–45.8) c |
| C24/Dose (ng/ml/mg) | 0.57 (29) | 11.2 (11) | 19.5 (16.7–22.9) c |
| Cmax (ng/ml) | 6.66 (33) | 10.7 (7) | – |
| AUCinf (ng•h/ml) | 178 (33) | 1700 (8) | – |
| C24 (ng/m) | 1.14 (29) | 5.59 (11) | – |
| Tmax (h) a | 2.5 (1.5–4.0) | 6.0 (3.0–6.0) | – |
| t 1/2 (h) b | 96.3 (15) | 249 (23) | – |
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; C24, blood concentration at 24 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.