Table 4.
Summary of pharmacokinetic parameters of serum concentration by 6 μg/kg per week dosing of PEG IFN‐α‐2b at weeks 1 and 8
| Week | Dose (μg/kg) | n | Tmax † (h) | Cmax (pg/mL) | C168 h (pg/mL) | AUC0–168 h (pg h/mL) | t 1/2 (h) | CL/F (mL/h per kg) | V/F (mL/kg) | R‡ |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 6 | 9 | 23.6 (22.5–71.9) | 2252 (35) | 330 (104) | 195 173¶ (44) | 46.1¶ (35) | 26.9¶ (49) | 1787¶ (43) | NA |
| 8 | 6 | 7§ | 23.9 (22.4–47.8) | 3078 (53) | 719 (36) | 295 233 (25) | 65.3 (36) | 20.3 (25) | 1915 (60) | 1.63‡‡ (53) |
| 6§§ | 23.7 (22.4–47.8) | 3338 (52) | 702 (39) | 306 909 (25) | 61.8 (35) | 19.5 (25) | 1743 (58) | 1.78†† (49) |
†Median (range). ‡Arithmetical mean (%CV). §Excluded two patients who were not administrated PEG IFN‐α‐2b at week 8. ¶ n = 8, †† n = 5, ‡‡ n = 6. §§Excluded three patients who were not administrated PEG IFN‐α‐2b at weeks 7 or 8. Geometric mean (%CV based on geometric mean). AUC, area under the concentration–time curve; CL/F, apparent total body clearance; Cmax, maximum observed serum concentration; CV, coefficient of variation; PEG IFN, pegylated interferon; R, accumulation factor; t 1/2, terminal phase (elimination) half‐life; Tmax, time to maximum observed serum concentration; V/F, apparent volume of distribution.