Table 6.
Comparison of pharmacokinetic parameters of IFNα2a between the first and last dosing in each treatment group
| t 1/2 | T max | C max | AUC 0–t | AUC 0–∞ | ||
|---|---|---|---|---|---|---|
| Group | h | h | pg ml −1 | pg ml −1 *h | pg ml −1 *h | |
| rHSA/IFNα2a 600 μg | First dose | 135.01 ± 36.47 | 75.00 ± 30.59 | 11 167.54 ± 6341.74 | 2 381 878.01 ± 879 806.14 | 2 518 504.60 ± 1 022 285.89 |
| Last dose | 121.61 ± 46.76 | 74.00 ± 20.67 | 12 602.02 ± 9248.22 | 3 094 334.86 ± 1 948 097.91 | 3 241 543.80 ± 2 060 188.09 | |
| P | 0.92 | 0.72 | 0.35 | 0.35 | 0.35 | |
| rHSA/IFNα2a 750 μg | First dose | 146.81 ± 53.16 | 102.00 ± 42.55 | 13 087.84 ± 4721.09 | 3 469 923.88 ± 1 077 195.14 | 3 758 873.40 ± 1 460 815.12 |
| Last dose | 114.02 ± 38.72 | 80.57 ± 27.46 | 12 723.33 ± 5572.80 | 3 525 403.11 ± 1 927 750.91 | 3 666 225.14 ± 2 027 391.45 | |
| P | 0.31 | 0.23 | 0.87 | 0.4 | 0.74 | |
| rHSA/IFNα2a 900 μg | First dose | 122.80 ± 58.90 | 117.00 ± 59.05 | 12 346.84 ± 5962.98 | 3 360 387.88 ± 1 277 834.78 | 3 552 902.90 ± 1567 601.55 |
| Last dose | 107.76 ± 41.63 | 56.57 ± 13.35 | 20 285.66 ± 6933.92 | 4 540 507.10 ± 1 288 646.44 | 4 694 539.83 ± 1432 681.48 | |
| P | 0.87 | 0.02 | 0.06 | 0.18 | 0.24 | |
| PEG‐IFNα2a 180 μg | First dose | 58.49 ± 41.67 | 76.50 ± 47.97 | 8844.80 ± 5896.85 | 997 666.67 ± 582 275.47 | 1 096 047.58 ± 510 189.16 |
| Last dose | 112.40 ± 29.14 | 69.00 ± 8.49 | 15 510.89 ± 4961.44 | 3 761 834.45 ± 707 272.76 | 3 938 956.18 ± 856 911.91 | |
| P | 0.06 | 1 | 0.01 | 0.01 | 0.03 |
| Group | CLz/F | MRT 0–∞ | Vz/F | Df | R | Cavg | |
|---|---|---|---|---|---|---|---|
| L h −1 | h | L | % | – | pg ml −1 | ||
| rHSA/IFNα2a 600 μg | First dose | 0.35 ± 0.10 | 255.44 ± 55.19 | 64.22 ± 14.26 | |||
| Last dose | 2.68 ± 6.00 | 229.04 ± 71.46 | 161.24 ± 285.76 | 166.97 ± 96.49 | 1.19 ± 0.11 | 7331.42 ± 4725.62 | |
| P | 0.35 | 0.92 | 0.35 | ||||
| rHSA/IFNα2a 750 μg | First dose | 0.31 ± 0.10 | 294.83 ± 94.74 | 63.26 ± 21.08 | |||
| Last dose | 0.43 ± 0.43 | 243.34 ± 70.08 | 52.93 ± 19.92 | 74.14 ± 125.49 | 0.1 ± 1.16 | 4156.16 ± 6831.17 | |
| P | 0.74 | 0.31 | 0.31 | ||||
| rHSA/IFNα2a 900 μg | First dose | 0.39 ± 0.14 | 279.55 ± 85.73 | 65.53 ± 30.69 | |||
| Last dose | 0.25 ± 0.05 | 218.84 ± 78.44 | 37.17 ± 12.06 | 73.08 ± 135.66 | 0.11 ± 1.14 | 2267.22 ± 10 869.59 | |
| P | 0.09 | 0.04 | 0.02 | ||||
| PEG‐IFNα2a 180 μg | First dose | 2.35 ± 3.92 | 130.80 ± 67.30 | 93.75 ± 98.69 | |||
| Last dose | 0.39 ± 0.14 | 207.54 ± 32.82 | 54.98 ± 13.46 | 55.9 ± 22.61 | 1.55 ± 0.23 | 12 573.85 ± 3706.2 | |
| P | 0.01 | 0.06 | 0.5 |
Last dose: IFNα2a serum concentration achieved a steady state after multiple doses, and pharmacokinetic parameters were C ssmax, AUCss0–t, AUCss0–∞, t ss 1/2, T ssmax, CLz/Fss, MRTss0–∞, and Vz/Fss, respectively.