Table 4 Safety profile of DAAs regimens
Patients (N = 144) | Group A (N = 101) | Group B (N = 43) | p-value | |
|---|---|---|---|---|
At least 1 adverse event,n(%) | 60 (41,6%) | 49 (48.5%) | 11 (25.6%) | 0.015 |
> 2 adverse events,n(%) | 7 (4.8%) | 6 (5.9%) | 1 (2.3%) | 0.674 |
Severe adverse events,n(%) | 10 (6.9%) | 8 (7.9%) | 2 (4.6%) | 0.723 |
Adverse events leading to discontinuation,n(%) | 3 (2.1%) | 2 (1.9%) | 1 (2.3%) | 1.000 |
Skin reactionsa,n(%) | 11 (7.6%) | 9 (8.9%) | 2 (4.6%) | 0.506 |
Anemia,n(%) | 7 (4.8%) | 5 (4.9%) | 2 (4.6%) | 1.000 |
Requiring erythropoietin | 2 (1.3%) | 2 (1.9%) | 0 | |
Requiring RBV dose adjustment | 4 (2.7%) | 2 (1.9%) | 2 (4.6%) | |
Requiring hospitalization | 1 (0.7%) | 1 (0.9%) | 0 | |
Gastrointestinal toxicityb,n(%) | 11 (7.6%) | 9 (8.9%) | 2 (4.6%) | 0.506 |
Cardiac disordersc,n(%) | 6 (4.1%) | 5 (4.9%) | 1 (2.3%) | 0.669 |
Neurological symtomps,n(%) | 26 (18.0%) | 20 (19.8%) | 6 (13.9%) | 0.483 |
Asthenia | 15 (10.4%) | 12 (11.8%) | 3 (6.9%) | 0.553 |
Headache | 10 (6.9%) | 9 (8.9%) | 1 (2.3%) | 0.281 |
Insomnia | 8 (5.5%) | 6 (5.9%) | 2 (4.6%) | 1.000 |
Amnesia | 1 (0.7%) | 1 (0.9%) | 0 | 1.000 |
Seizures | 1 (0.7%) | 0 | 1 (2.4%) | 0.298 |
Psychiatric symtomps,n(%) | 8 (5.5%) | 8 (7.9%) | 0 | 0.105 |
Anxiety | 1 (0.7%) | 1 (0.9%) | 0 | 1.000 |
Mood disorders | 7 (4.8%) | 7 (6.9%) | 0 | 0.103 |