Table 4 Adverse events in all patients with chronic HCV infection
Variables | Total | PEG-IFN alfa-2a | PEG-IFN alfa-2b | P* |
|---|---|---|---|---|
(N=661) | (N=402) | (N=259) | ||
Overall AE, N (%) | 542 (82.0) | 312 (77.6) | 230 (88.8) | |
Grade 1-2/3† | 493/49 (91.0/9.0) | 288/24 (92.3/7.7) | 205/25 (89.1/10.9) | 0.23 |
Common AE, N (%) | ||||
Flu-like symptoms | ||||
Grade 1-2/3 | 421/0 (63.7/0) | 229/0 (57.0/0) | 192/0 (74.1/0) | <0.01 |
GI symptoms | ||||
Grade 1-2/3 | 152/11 (23.0/1.7) | 82/6 (20.4/1.5) | 70/5 (27.0/1.9) | 0.12 |
Dermatologic reactions | ||||
Grade 1-2/3 | 74/2 (11.2/0.3) | 38/1 (9.5/0.2) | 36/1 (13.9/0.4) | 0.19 |
Emotional friability | ||||
Grade 1-2/3 | 183/23 (27.7/3.5) | 102/11 (25.4/2.7) | 81/12 (31.3/4.6) | 0.08 |
Alopecia | ||||
Grade 1-2/3 | 96/20 (14.5/3.0) | 50/7 (12.4/1.7) | 46/13 (17.8/5.0) | <0.01 |
Hematologic events, N (%) | ||||
ANC, <500/mm3 | 3 (0.5) | 0 (0) | 3 (1.2) | 0.06 |
Hemoglobin, <8.5 g/dL | 25 (3.8) | 15 (3.7) | 10 (3.9) | 1.00 |
Platelet, <25,000/mm3 | 6 (0.9) | 6 (1.5) | 0 (0) | 0.09 |
Serious AE, N (%) | ||||
Severe infection or death | 2 (0.3) | 2 (0.5) | 0 (0) | 0.52 |
Patients who did not meet 80/80/80 rule | 181 (27.4) | 118 (29.4) | 63 (24.3) | 0.18 |
Dose modification, N (%) | 82 (45.3) | 58 (49.23) | 24 (38.1) | 0.16 |
Discontinuation, N (%) | 99 (54.7) | 60 (60.6) | 39 (39.4) | 0.52 |
AE/hematologic event | 47 (47.5) | 27 (45.0) | 20 (51.3) | 0.68 |
Non-virologic response | 18 (18.2) | 10 (16.7) | 8 (20.5) | 0.79 |
Incidental severe infection | 2 (2.0) | 2 (3.3) | 0 (0) | 0.52 |
Follow-up loss | 32 (32.3) | 21 (35.0) | 11 (28.2) | 0.48 |