TABLE 4.
MPA PK parameters in study subjects and historical controlsa
| Parameter | AUC0–12 wk (ng · wk/ml) |
Cmin (ng/ml) |
Cmax (ng/ml) |
Tmax (wk) |
CL/F (liters/wk) |
t1/2 (wk) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controls | With LPV/r | Controls | With LPV/r | Controls | With LPV/r | Controls | With LPV/r | Controls | With LPV/r | Controls | With LPV/r | |
| Mean | 11.48 | 19.53 | 0.45 | 0.54 | 1.64 | 3.10 | 2.57 | 4.17 | 14,193.29 | 8,820.89 | 9.01 | 27.05 |
| SD | 3.10 | 6.51 | 0.24 | 0.36 | 0.56 | 1.35 | 0.94 | 2.76 | 4,645.24 | 4,251.24 | 11.04 | 107.59 |
| Median | 12.38 | 18.08 | 0.43 | 0.47 | 1.74 | 2.88 | 2.00 | 4.00 | 12,117.10 | 8,297.35 | 5.37 | 3.37 |
| IQR (Q1, Q3) | 8.88, 13.88 | 16.22, 24.10 | 0.29, 0.60 | 0.35, 0.74 | 1.02, 2.09 | 2.28, 4.04 | 2.00, 4.00 | 2.00, 4.00 | 10,808.03, 16,890.53 | 6,223.57, 9,250.23 | 3.04, 12.15 | 2.05, 5.42 |
| Range (minimum, maximum) | 6.03, 15.64 | 5.91, 32.33 | 0.04, 0.89 | 0.03, 1.43 | 0.88, 2.58 | 0.84, 5.88 | 2.00, 4.00 | 2.00, 12.00 | 9,588.34, 24,881.39 | 4,639.14, 25,385.74 | 1.54, 44.76 | 1.11, 508.53 |
| P valueb | <0.001 | 0.565 | <0.001 | 0.027 | <0.001 | 0.116 | ||||||
a
Data are for 14 control subjects and 24 subjects treated with LPV/r, except for t1/2 with LPV/r, for which there were 22 subjects. AUC0–12 wk, area under the concentration-time curve over the dosing period of 12 weeks; Cmin, minimum concentration; Cmax, maximum concentration; Tmax, time to Cmax; CL/F, apparent clearance; t1/2, half-life; Q1, first quartile; Q3, third quartile.
b
P value by Wilcoxon rank sum test.