Table 2.
Patient disposition, sustained virologic response, safety profile, and anaemia management.
| Boceprevir (n = 455) | Telaprevir (n = 1629) | All patients (n = 2084) | |
|---|---|---|---|
| Patient disposition during treatment, n (%) | |||
| Completed therapy | 255 (56) | 989 (61) | 1244 (60) |
| Discontinued early | 200 (44) | 621 (38) | 821 (39) |
| Adverse event | 83 (18) | 290 (18) | 373 (18) |
| Lack of efficacy | 89 (20) | 255 (16) | 344 (17) |
| Lost to follow-up | 22 (5) | 48 (3) | 70 (3) |
| Other | 6 (1) | 28 (2) | 34 (2) |
| No EOT data | 0 | 19 (1) | 19 (<1) |
| Sustained virologic response, n (%, 95% CI) | 200 (44, 39–49) | 883 (54, 52–57) | 1083 (52, 50–54) |
| Adverse events, n (%) | 422 (93) | 1561 (96) | 1983 (95) |
| Anaemia | 310 (68) | 1056 (65) | 1366 (66) |
| Rash | 155 (34) | 1026 (63) | 1181 (57) |
| Anorectal symptoms | 43 (9) | 648 (40) | 691 (33) |
| Infection | 78 (17) | 242 (15) | 320 (15) |
| Dysgeusia | 57 (13) | 65 (4) | 112 (6) |
| Decompensating event | 12 (3) | 56 (3) | 68 (3) |
| Serious adverse events, n (%) | 57 (13) | 183 (11) | 240 (12) |
| Anaemia | 18 (4) | 57 (3) | 75 (4) |
| Infection | 14 (3) | 43 (3) | 57 (3) |
| Other | 8 (2) | 29 (2) | 37 (2) |
| Decompensation | 3 (<1) | 13 (<1) | 16 (<1) |
| Rash | 0 | 8 (<1)* | 8 (<1) |
| Anorectal symptoms | 0 | 7 (<1) | 7 (<1) |
| Dysgeusia | 0 | 0 | 0 |
| Haemoglobin decline, n (%) | |||
| Haemoglobin <10 g/dl | 236 (52) | 812 (50) | 1048 (50) |
| Haemoglobin <8.5 g/dl | 69 (15) | 285 (17) | 354 (17) |
| Anaemia management, n (%) | |||
| Ribavirin dose reduction | 188 (41) | 686 (42) | 874 (42) |
| Epoetin use | 182 (40) | 580 (36) | 762 (37) |
| Blood transfusion | 44 (10) | 193 (12) | 237 (11) |
| Ribavirin interruptions | 16 (4) | 41 (3) | 57 (3) |
| Deaths, n | 0 | 5 | 5 |
*
SAE rash included 2 patients with DRESS.