Table 2.
Statistical summary of pharmacokinetic and pharmacodynamic parameters.
| Week | N | Median | 90% CI on Median | CV(%) | Range (Min, Max) | ||
|---|---|---|---|---|---|---|---|
| Interferon | Concentration (ng/mL) | 1 | 10 | 11.80 | (9.94, 16.60) | 28% | (8.52, 19.20) |
| 2 | 11 | 16.70 | (13.80, 19.40) | 32% | (3.84, 21.20) | ||
| 3 | 11 | 18.10 | (10.10, 20.40) | 42% | (2.96, 27.50) | ||
| 6 | 11 | 21.00 | (19.50, 23.40) | 22% | (9.95, 27.80) | ||
| 12 | 11 | 21.90 | (19.30, 25.20) | 25% | (10.20, 27.50) | ||
| 13 | 11 | 6.69 | (3.42, 11.00) | 68% | (3.01, 22.10) | ||
| 18 | 10 | 0.13 | (0.13, 0.49) | 83% | (0.13, 0.77) | ||
| Average steady state concentration (ng/mL) | 11 | 21.53 | (20.08, 24.25) | 20% | (11.28, 26.58) | ||
| Clearance (L/h) | 11 | 0.047 | (0.043, 0.053) | 21% | (0.037, 0.071) | ||
| Weight adjusted clearance (L/h/kg) | 11 | 0.0006 | (0.0005, 0.0007) | 31% | (0.0004, 0.0012) | ||
| AUC0-12 (ng.wk/mL) | 11 | 219.45 | (183.34, 242.15) | 17% | (147.67, 275.96) | ||
| OAS | Concentration (pmol/dL) | 0 | 11 | 86.74 | (43.01, 148.06) | 125% | (14.91, 588.91) |
| 1 | 10 | 202.03 | (132.99, 304.46) | 64% | (5.00, 484.60) | ||
| 2 | 10 | 212.92 | (170.56, 310.71) | 39% | (150.71, 445.50) | ||
| 3 | 11 | 194.69 | (128.57, 346.88) | 54% | (104.45, 492.49) | ||
| 6 | 11 | 234.57 | (120.64, 293.92) | 50% | (79.38, 456.52) | ||
| 12 | 11 | 177.11 | (114.62, 285.04) | 57% | (79.82, 485.65) | ||
| 13 | 11 | 166.69 | (123.70, 282.89) | 49% | (62.17, 359.07) | ||
| 18 | 10 | 107.52 | (80.68, 200.89) | 46% | (71.71, 242.99) | ||
| Change in concentration from baseline | 1 | 10 | 71.84 | (51.48, 161.52) | (-104.31, 164.07) | ||
| 2 | 10 | 140.69 | (67.13, 176.22) | (-143.41, 233.46) | |||
| 3 | 11 | 127.57 | (31.50, 170.47) | (-96.42, 294.49) | |||
| 6 | 11 | 134.02 | (61.69, 193.39) | (-132.40, 222.97) | |||
| 12 | 11 | 100.04 | (18.78, 216.45) | (-103.26, 317.49) | |||
| 13 | 11 | 93.72 | (-29.51, 123.67) | (-229.84, 271.07) | |||
| 18 | 10 | 51.75 | (19.66, 103.52) | (-60.86, 114.15) | |||
| IFIG | Concentration (MFI) | 0 | 8 | 4.94 | (4.53, 6.04) | 13% | (4.46, 6.16) |
| 3 | 8 | 6.21 | (5.80, 6.57) | 6% | (5.63, 6.70) | ||
| 6 | 8 | 6.44 | (6.24, 6.75) | 5% | (5.85, 6.87) | ||
| 12 | 8 | 6.45 | (6.27, 6.73) | 4% | (6.16, 6.95) | ||
| 18 | 7 | 5.04 | (4.61, 6.02) | 15% | (3.74, 6.02) | ||
| Change in concentration from baseline | 3 | 8 | 1.09 | (0.41, 1.59) | (-0.41, 2.17) | ||
| 6 | 8 | 1.15 | (0.58, 2.10) | (0.24, 2.34) | |||
| 12 | 8 | 1.30 | (0.57, 2.17) | (0.23, 2.49) | |||
| 18 | 7 | -0.17 | (-0.41, 0.63) | (-0.72, 0.63) | |||