| Variables |
Total |
PEG-IFN alfa-2a |
PEG-IFN alfa-2b |
P* |
| N (%) |
661 |
402 (60.8) |
259 (39.2) |
|
| Overall AE, N (%) |
| Grade 1-2/3† |
493/49 (74.6/7.4) |
288/24 (71.6/6.0) |
205/25 (79.2/9.7) |
0.23 |
| Common AE, N (%) |
| Flu-like symptoms |
| Grade 1-2/3 |
421/0 (63.7/0) |
229/0 (56.9/0) |
192/0 (74.2/0) |
NA |
| 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) |
0.09 |
| 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 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 |
Abbreviation
HCV - Hepatitis C Virus; AE - Adverse Event; GI - Gastrointestinal; ANC - Absolute Neutrophil Count; PEG –IFN - Peg-Interferon; NA - Not Available
*P-value for difference between the PEG-IFN alfa-2a and PEG-IFN alfa-2b groups
†Most severe grade among adverse events that patients had experienced during treatment |
