Numbers of patients reporting AEs and laboratory abnormalities
| Outcomes, n (%) | 48-week PegIFN (group A, N=51) | 96-week PegIFN (group B, N=52) | PegIFN + lamivudine (group C, N=25) | p Value* (A vs B) |
| One or more treatment-related AE | 42 (82.4) | 41 (78.8) | 20 (80.0) | 0.8041 |
| One or more SAE | 8 (15.7) | 3 (5.8) | 6 (24.0) | 0.1222 |
| Deaths | 1† | 0 | 0 | 0.4951 |
| Most common AEs‡ | ||||
| Fever | 19 (37.3) | 19 (36.5) | 8 (32.0) | 1.000 |
| Asthenia | 17 (33.3) | 19 (36.5) | 11 (44.0) | 0.6661 |
| Flu-like symptoms | 9 (17.6) | 10 (19.2) | 4 (16.0) | 0.7997 |
| Headache | 13 (25.5) | 8 (15.4) | 7 (28.0) | 0.3173 |
| Myalgia | 7 (13.7) | 8 (15.4) | 4 (16.0) | 0.7830 |
| Arthralgia | 6 (11.8) | 6 (11.5) | 3 (12.0) | 1.000 |
| Back pain | 3 (5.9) | 6 (11.5) | 2 (8.0) | 0.3141 |
| Muscular weakness | 0 | 0 | 2 (8.0) | NA |
| Nausea | 5 (9.8) | 2 (3.8) | 2 (8.0) | 0.4336 |
| Abdominal pain | 4 (7.8) | 4 (7.7) | 3 (12.0) | 1.000 |
| Diarrhoea | 1 (2.0) | 3 (5.8) | 2 (8.0) | 0.3604 |
| Dyspepsia | 1 (2.0) | 4 (7.7) | 2 (8.0) | 0.2024 |
| Anxiety | 4 (7.8) | 5 (9.6) | 2 (8.0) | 0.7387 |
| Insomnia | 4 (7.8) | 0 | 2 (8.0) | 0.1164 |
| Irritability | 0 | 3 (5.8) | 2 (8.0) | 0.1164 |
| Nervousness | 0 | 3 (5.8) | 1 (4.0) | 0.1164 |
| Pruritus | 5 (9.8) | 6 (11.5) | 3 (12.0) | 0.7574 |
| Alopecia | 3 (5.9) | 3 (5.8) | 1 (4.0) | 1.000 |
| Urticaria | 1 (2.0) | 1 (1.9) | 2 (8.0) | 1.000 |
| Psoriasis | 0 | 3 (5.8) | 0 | 0.1164 |
| Sciatica | 1 (2.0) | 3 (5.8) | 0 | 0.3604 |
| Pharyngitis | 3 (5.9) | 2 (3.8) | 0 | 1.000 |
| Urinary tract infection | 3 (5.9) | 1 (1.9) | 0 | 0.6162 |
| Tooth abscess | 0 | 1 (1.9) | 2 (8.0) | 0.4943 |
| Cough | 3 (5.9) | 6 (11.5) | 0 | 0.3141 |
| Anorexia | 2 (3.9) | 6 (11.5) | 0 | 0.1567 |
| Hypertension | 1 (2.0) | 4 (7.7) | 0 | 0.2024 |
| Vertigo | 1 (2.0) | 1 (1.9) | 2 (8.0) | 1.000 |
| Laboratory abnormalities | ||||
| ALT increased | 3 (5.9) | 8 (15.4) | 4 (16.0) | 0.2008 |
| Neutropenia | 12 (23.5) | 9 (17.3) | 3 (12.0) | 0.4719 |
| Thrombocytopenia | 6 (11.8) | 6 (11.5) | 1 (4.0) | 1.000 |
| Anaemia | 5 (9.8) | 4 (7.7) | 1 (4.0) | 0.7412 |
| Dose modification | 15 (29.4) | 7 (13.5) | 9 (36.0) | 0.0573 |
| Discontinuation | ||||
| Overall | 10 (19.6) | 12 (23.1) | 8 (32.0) | 0.8107 |
| Due to AEs | 8 (15.7) | 6 (11.5) | 6 (24.0) | 0.2043 |
Patients may have more than one AE.
↵* Two-sided Fisher exact test, 48-week vs 96-week PegIFN.
↵† Metastatic hepatocellular carcinoma during follow-up.
↵‡ Reported by at least 5% of patients in one of the treatment groups between first study dose up to 8 weeks after therapy.
AE, adverse event; ALT, alanine aminotransferase; PegIFN, peginterferon α-2a; SAE, serious adverse event.