Reasons for discontinuation of telaprevir and the incidence of the most common grade 2–4 drug-related AEs and serious AEs
| Variable | Bridging fibrosis (F3)* (N=752) | Cirrhosis (F4) (N=835) | Overall (N=1587) | p Value |
|---|---|---|---|---|
| Grade 2–4 drug-related AE†—no. (%) | ||||
| Patients with one or more AE | 453 (60) | 561 (67) | 1014 (64) | <0.01 |
| Anaemia‡ | 307 (41) | 391 (47) | 698 (44) | 0.02 |
| Rash‡ | 90 (12) | 111 (13) | 201 (13) | NS |
| Thrombocytopenia‡ | 37 (5) | 83 (10) | 120 (8) | <0.01 |
| Pruritus‡ | 37 (5) | 58 (7) | 95 (6) | NS |
| Asthenia | 44 (6) | 47 (6) | 91 (6) | NS |
| Nausea | 24 (3) | 36 (4) | 60 (4) | NS |
| Anorectal‡ | 26 (3) | 35 (4) | 61 (4) | NS |
| Serious AEs§—no. (%) | ||||
| Patients with one or more serious AEs | 76 (10) | 110 (13) | 186 (12) | NS |
| Anaemia‡ | 32 (4) | 43 (5) | 75 (5) | NS |
| Rash‡ | 12 (2) | 16 (2) | 28 (2) | NS |
| Infection | 6 (1) | 20 (2) | 26 (2) | NS |
| Pyrexia | 4 (1) | 8 (1) | 12 (1) | NS |
| Reason for discontinuation¶—no. (%) | ||||
| Any AE | 80 (11) | 113 (14) | 193 (12) | NS |
| Rash‡ | 36 (5) | 36 (4) | 72 (5) | NS |
| Anaemia‡ | 14 (2) | 31 (4) | 45 (3) | 0.01 |
| Vomiting | 8 (1) | 9 (1) | 17 (1) | NS |
| Asthenia | 6 (1) | 10 (1) | 16 (1) | NS |
| Nausea | 7 (1) | 9 (1) | 16 (1) | NS |
| Pruritus‡ | 3 (0) | 10 (1) | 13 (1) | NS |
| Abdominal pain | 1 (0) | 8 (1) | 9 (1) | NS |
*Includes three F1 patients and three F2 patients.
†Listed are grade 2–4 drug-related AEs that occurred in at least 4% of the overall population.
‡Included in this category are all related events that were described with a variety of descriptive terms.
§Listed are serious AEs that occurred in at least 0.5% of the overall population.
¶Listed are discontinuations that occurred in at least 1% of the overall population. These figures are the number of patients who discontinued telaprevir; patients may have continued treatment with pegylated interferon plus ribavirin.
AE, adverse event.