Table 2. Summary of patients experiencing AEs (on-treatment) during the entire treatment phase, overall and according to treatment group (12- or >12-week treatment).
| 12-week group (n = 123) | >12-week group (n = 40) | All patients (N = 163) | |
|---|---|---|---|
| AE | |||
| Any AE | 117 (95) | 37 (93) | 154 (94) |
| Any serious AE | 4 (3) | 2 (5) | 6 (4) |
| AE leading to discontinuation of ≥1 study drug | 0 | 4 (10)* | 4 (2) |
| Treatment-related AEs‡ | |||
| Any study drug | 110 (89) | 36 (90) | 146 (90) |
| Simeprevir¶ | 68 (55) | 20 (50) | 88 (54) |
| Ribavirin | 84 (68) | 30 (75) | 114 (70) |
| Peginterferon | 105 (85) | 33 (83) | 138 (85) |
| Worst grade AE | |||
| Grade 1 | 54 (44) | 13 (33) | 67 (41) |
| Grade 2 | 37 (30) | 16 (40) | 53 (33) |
| Grade 3 | 23 (19) | 5 (13) | 28 (17) |
| Grade 4 | 3 (2) | 3 (8) | 6 (4) |
*3 patients discontinued all treatment during the simeprevir+PR phase. One patient discontinued PR during the PR-only phase.
‡AEs considered by the investigator to be at least possibly related to specified study drug
¶Grade 3 AEs considered by the investigator to be at least possibly related to simeprevir were experienced by 8 (5%) patients, as follows: rash (n = 2), depression (n = 1), asthenia (n = 1), hyponatremia (n = 1), hyperbilirubinemia (n = 1), neutropenia (n = 1), and increase in blood bilirubin (n = 1). No Grade 4 AEs were considered by the investigator to be at least possibly related to simeprevir. AE, adverse event.