Table 2. On-treatment AEs Reported During the Study Period.
| Treatment duration | All patients | ||
|---|---|---|---|
| 12 weeks (n = 34) | 24 weeks (n = 33) | All patients (N = 67) | |
| Any AE | 31 (91) | 29 (88) | 60 (90) |
| Any serious AE | 0 | 2 (6) | 2 (3) |
| Any AE at least possibly related to simeprevir | 10 (29) | 15 (45) | 25 (37) |
| Any AE at least possibly related to peg-IFN | 20 (59) | 26 (79) | 46 (69) |
| Any AE at least possibly related to RBV | 17 (50) | 19 (58) | 36 (54) |
| Any AE leading to permanent stop of all study drugs | 0 | 3 (9) | 3 (4) |
| Worst Grade 3 or 4 AE* | 6 (18) | 14 (42) | 20 (30) |
| Most commonly reported AE† | |||
| Pruritus | 9 (26) | 7 (21) | 16 (24) |
| Neutropenia | 9 (26) | 7 (21) | 16 (24) |
| Asthenia | 5 (15) | 9 (27) | 14 (21) |
| Fatigue | 6 (18) | 8 (24) | 14 (21) |
| Decreased appetite | 6 (18) | 8 (24) | 14 (21) |
| Headache | 5 (15) | 8 (24) | 13 (19) |
| Influenza-like illness | 3 (9) | 9 (27) | 12 (18) |
AE, adverse event; peg-IFN, pegylated interferon; RBV, ribavirin.
*Three Grade 3 AEs were considered at least possibly related to simeprevir: asthenia (n = 2) and blood bilirubin increase (n = 1), all in the 24-week group. No Grade 4 AEs were considered at least possibly related to simeprevir.
†Occurring in ≥20% of patients in either treatment group.