Table 2.
17-BMP Pharmacokinetic Parameters
| Geometric Mean Values (90% CI) | Geometric Mean Ratio (90% CI) | |||
|---|---|---|---|---|
| Day 14 | Day 28 | Day 28/Day 14 | p-value* | |
| Group 1 | BDP Alone | BDP Alone | ||
| AUC0–12 (pcg*h/mL) | 3342 (2988 – 3695) | 3116 (2846 – 3386) | 0.93 (0.81 – 1.06) | 0.27 |
| Cmax (pcg/mL) | 935 (823 – 1048) | 1043 (909 – 1178) | 1.12 (0.83 – 1.40) | 0.38 |
| Tmax (h) | 0.5 (0.5 – 1.0)† | 0.5 (0.5 – 1.0)† | – | 0.59 |
| T1/2 (h) | 3.2 (2.8 – 3.7) | 2.6 (2.3 – 2.9) | 0.81 (0.61 – 1.02) | 0.07 |
| Clss/F | 47.9 (41.2 – 54.6) | 51.4 (47.2 – 55.5) | 1.07 (0.96 – 1.18) | 0.54 |
| Group 2 | BDP Alone | BDP + RTV | ||
| AUC0–12 (pcg*h/mL) | 2126 (1662 – 2590) | 4426 (3117 – 5734) | 2.08 (1.52 – 2.65) | 0.006 |
| Cmax (pcg/mL) | 576 (434 – 719) | 963 (728 – 1198) | 1.67 (1.33 – 2.01) | 0.006 |
| Tmax (h) | 0.5 (0.5 – 1.0)† | 1.0 (0.5 – 4.0)† | – | 0.20 |
| T1/2 (h) | 3.7 (2.7 – 4.6) | 3.7 (3.2 – 4.3) | 1.02 (0.7 – 1.3) | 0.82 |
| Clss/F | 75.2 (36.3 – 114.2) | 35.6 (17.5 – 53.8) | 0.47 (0.37 – 0.57) | 0.01 |
| Group 3 | BDP Alone | BDP + DRV/r | ||
| AUC0–12 (pcg*h/mL) | 3202 (2695 – 3708) | 2840 (2247 – 3433) | 0.89 (0.68 – 1.09) | 0.61 |
| Cmax (pcg/mL) | 889 (736 – 1043) | 716 (559 – 873) | 0.81 (0.69 – 0.92) | 0.06 |
| Tmax (h) | 0.5 (0 – 1.0)† | 0.5 (0.5 – 1.0)† | – | 0.71 |
| T1/2 (h) | 3.9 (3.5 – 4.4) | 3.6 (3.0 – 4.1) | 0.9 (0.7 – 1.2) | 0.59 |
| Clss/F | 49.5 (41.2 – 57.8) | 55.5 (25.7 – 85.2) | 1.12 (0.80 – 1.45) | 0.36 |
AUC0–12 = area under the concentration vs. time curve, Cmax = maximum concentration, Tmax = time to maximum concentration, T1/2 = half-life, Clss/F = apparent inhalation clearance, BDP = inhaled beclomethasone dipropionate, RTV = ritonavir, DRV/r = darunavir/ritonavir
*
Student's paired, two-tailed t-test was used for all statistical comparisons, except for Tmax (Wilcoxon signed rank).
†
Median values (ranges)