Table 2.
Clinical Endpoints (SR/CR) in the Long-Term Follow-Up Study
| PEG-IFN alfa-2b 1.0 μg /kg/wk. 24 weeks | PEG-IFN alfa-2b 1.5 μg /kg/wk. 24 weeks | PEG-IFN alfa-2b 1.5 μg /kg/wk. 48 weeks | |
|---|---|---|---|
| P05170 | 225 | 221 | 224 |
| SR at EOS | 38 (16.9) | 36 (16.3) | 67 (29.9) |
| CR at EOS | 18 (8.0) | 23 (10.4) | 45 (20.1) |
| Eligible for LTFU | 210 | 198 | 207 |
| Included for LTFU | 114 (54.3) | 97 (49.0) | 111 (53.6) |
| SR at EOS | 21 (18.4) | 20 (20.6) | 34 (30.6) |
| CR at EOS | 10 (8.8) | 9 (9.3) | 20 (18.0) |
| No additional NAs | 65 (57.0) | 56 (57.7) | 58 (52.3) |
| Treated with NAs | 49 (43.0) | 41 (42.3) | 53 (47.8) |
| Sustained response from EOS* | |||
| SR at LTFU# | 13 (61.9) | 13 (65.5) | 26 (76.5) |
| SR at LTFU with NA | 17 (81.0) | 17 (85.0) | 30 (88.2) |
| NA for SR relapse | 8 (38.1) | 7 (35.0) | 8 (23.5) |
| CR at LTFU | 4 (40.0) | 3 (33.3) | 15 (75.0) |
| CR at LTFU with NA | 5 (50.0) | 4 (44.4) | 16 (80.0) |
| NA for CR relapse | 6 (60.0) | 6 (66.7) | 5 (25.0) |
| EOS non-SR patients§ | 93 | 77 | 77 |
| New SR at LTFU | 27 (29.0) | 23 (29.9) | 14 (18.2) |
| New SR at LTFU with NA | 45 (48.4) | 38 (49.4) | 32 (41.6) |
| EOS non-CR patients§ | 104 | 88 | 91 |
| New CR at LTFU | 19 (18.3) | 13 (14.8) | 14 (15.4) |
| New CR at LTFU with NA | 35 (33.7) | 30 (28.8) | 34 (32.7) |
Overall data are presented as n (%). Chi-square test was used for statistical comparisons of SR and CR at the LTFU respectively
*Sustained response from EOS = patients with a response at EOS and response at LTFU/patients with response at EOS; p = NS for comparisons on SR or CR relapse
#p = 0.46 for SR at LTFU; Sustained SR at LTFU among all patients included in the LTFU in 3 groups: 11.4, 13.4, 23.4%, p = 0.03
p = 0.05 for CR at LTFU; Sustained CR at LTFU among all patients included in the LTFU in 3 groups: 3.5, 3.1, 13.5%, p < 0.01
§Patients who failed SR or CR at the EOS; p = NS for comparisons on new SR or new CR
SR HBeAg loss and seroconversion to anti-HBe, CR HBe seroconversion and HBV-DNA less than 2000 IU/mL, relapse patients who had SR/CR non-response at LTFU or were treated with additional antivirals after EOS, EOS end of (P05170) study, LTFU long-term follow-up; NA nucleos(t)ide analogs, SR serological response; CR complete response