TABLE 4.
Extent of Exposure (the Safety Population)
| Peginterferon Alfa-2a | Prophylaxis Arm (n = 54) | Observation Arm: Switched to Treatment (n = 14) |
|---|---|---|
| Treatment duration, n (%)* | ||
| 0-14 days | 1 (1.9) | 0 |
| 15-28 days | 1 (1.9) | 0 |
| 29-56 days | 1 (1.9) | 0 |
| 57-84 days | 1 (1.9) | 0 |
| 85-168 days | 5 (9.3) | 3 (21.4) |
| 169-252 days | 7 (13.0) | 2 (14.3) |
| 253-336 days | 30 (55.6) | 4 (28.6) |
| >336 days | 8 (14.8) | 5 (35.7) |
| Average weekly dose (μg), mean ± SD | 170.0 ± 9.14 | 170.8 ± 5.80 |
| Patients with dose reduction for safety reasons, n (%)† | ||
| Total | 38 (70.4) | 9 (64.3) |
| Laboratory | 25 (46.3) | 7 (50.0) |
| AE | 24 (44.4) | 6 (42.9) |
| Ribavirin | Prophylaxis Arm (n = 54) | Observation Arm: Switched to Treatment (n = 14) |
|
| ||
| Treatment duration, n (%)* | ||
| 15-28 days | 3 (5.6) | 0 |
| 29-56 days | 1 (1.9) | 0 |
| 57-84 days | 1 (1.9) | 1 (7.1) |
| 85-168 days | 8 (14.8) | 3 (21.4) |
| 169-252 days | 7 (13.0) | 2 (14.3) |
| 253-336 days | 25 (46.3) | 3 (21.4) |
| >336 days | 9 (16.7) | 5 (35.7) |
| Average daily dose (mg), mean ± SD | 671.4 ± 238.44 | 630.6 ± 222.23 |
| Patients with dose reduction for safety reasons, n (%)† | ||
| Total | 39 (72.2) | 10 (71.4) |
| Laboratory | 19 (35.2) | 8 (57.1) |
| AE | 29 (53.7) | 5 (35.7) |
*
Days from the first treatment to the last treatment (ie, the date of the last treatment minus the date of the first treatment plus 1).
†
More than 1 reason could be reported because of multiple dose reductions per patient; when a patient had more than 1 dose reduction for the same reason, the patient was counted once for that reason.