Table 2.
Treatment exposure during the PROTECT VIII extension study
| Prophylaxis | On demand (n = 14) | |||||
|---|---|---|---|---|---|---|
| Twice weekly (n = 23) | Every 5 days (n = 33) | Every 7 days (n = 23) | Variable frequency* (n = 28) | Total prophylaxis (n = 107) | ||
| Days in extension study | ||||||
| Median (range) | 480.0 (45‐1686) | 624.1 (112‐1686) | 1129.0 (110‐1695) | 1480.9 (182‐1707) | 1162.9 (45‐1707) | 1156.4 (203‐1484) |
| Exposure days in extension study | ||||||
| Median (range) | 168.0 (11‐476) | 129.0 (23‐352) | 163.0 (9‐247) | 292.5 (46‐408) | 211.0 (9‐476) | 101.5 (13‐176) |
| Dose per prophylaxis infusion, IU/kg | ||||||
| Median (Q1; Q3) | 37.5 (31.3; 40.0) | 46.2 (44.3; 49.2) | 58.9 (55.9; 62.5) | 51.6 (44.4; 57.6) | 47.8 (42.4; 57.1) | NA |
| Total consumption, IU/kg/y | ||||||
| Median (Q1; Q3) | 3917 (3241; 4289) | 3504 (3186; 4093) | 3120 (2901; 3256) | 3742 (3346; 4064) | 3488 (3153; 4051) | 1394 (1059; 1715) |
Abbreviations: NA, not applicable; Q, quartile.
*
Patients who switched regimens during the extension (switched to a higher frequency, n = 20; switched to a lower frequency, n = 4; switched twice and were receiving their original frequency at interim analysis, n = 4).