TABLE 1.
Summary of the steady-state pharmacokinetics for TPV and RTVa
| PK parameter | TPV/r | TPV/r + EFV | GMR (90% CI) |
|---|---|---|---|
| TPV | |||
| AUC (h·μM) | 858.9 (28.9) | 834.2 (39.2) | 0.97 (0.87-1.09) |
| Cmax (μM) | 128.7 (22.0) | 118.0 (34.0) | 0.92 (0.81-1.03) |
| Cmin (μM) | 27.9 (57.1) | 33.3 (63.1) | 1.19 (0.93-1.54) |
| Tmax (h) | 2.0 (1.5-2.0) | 3.0 (1.5-4.0) | |
| t1/2 (h) | 4.0 (32.1) | 4.7 (32.4) | |
| Vz/F (liter) | 5.54 (31.4) | 6.72 (50.7) | |
| CL/F (liter/h) | 0.97 (28.9) | 0.99 (39.2) | |
| RTV | |||
| AUC (h·μg/ml) | 6.48 (50.8) | 6.70 (71.4) | 1.03 (0.78-1.38) |
| Cmax (μg/ml) | 1.52 (65.6) | 1.40 (89.1) | 0.92 (0.65-1.30) |
| Cmin (μg/ml) | 0.112 (101.5) | 0.116 (87.0) | 1.04 (0.72-1.48) |
| Tmax (h) | 4.0 (1-10.1) | 4.0 (1.5-12.0) | |
| t1/2 (h)b | 1.8 (23.6) | 2.0 (55.7) | |
| Vz/F (liter)b | 76.7 (54.2) | 78.3 (137.9) | |
| CL/F (L/h) | 30.9 (50.8) | 29.9 (71.4) |
a
Values are geometric means, with the geometric CV (%) given parenthetically, except for the Tmax value, which is a median, with the minimum to maximum values given parenthetically.
b
n = 15; for all others, n = 16.