Table 3.
Effectiveness and safety of DAA treatment based on the presence of DDIs
| Patients with DDI N=267 |
Patients without DDI N=825 | P value | |
| % (n) | % (n) | ||
| Virologic response | |||
| SVR12 | 97.7% (258) | 99.0% (804) | 0.109 |
| Null responder | 1.1% (3) | 0.5 (4) | 0.258 |
| Recurrent | 1.1% (3) | 1.6% (13) | 0.588 |
| No data | 1.1% (3) | 1.6% (13) | 0.593 |
| Drug-related adverse events | 55.8% (149) | 48.0% (396) | 0.027 |
| Drug-related serious adverse events | 1.5% (4) | 1.3% (11) | 0.841 |
| DAA treatment withdrawal due to drug-related AE | 0.0% (0) | 0.0% (0) | >0.999 |
| Concomitant treatment withdrawal secondary to drug-related AE | 0.0% (0) | 0.0% (0) | >0.999 |
| Emergency department admission secondary to drug-related AE | 0.0% (0) | 0.0% (0) | >0.999 |
| On-treatment hospitalisation secondary to drug-related AE | 0.38% (1) | 0.0% (0) | 0.552 |
| Death secondary to drug-related AE | 0% (0) | 0% (0) | >0.999 |
| Any grade AE with global incidence >2.0%: | |||
| Fatigue/asthenia | 32.2% (86) | 35.4% (292) | 0.342 |
| Headache | 15.0% (40) | 20.6% (170) | 0.043 |
| Pruritus | 6.4% (17) | 6.4% (53) | 0.974 |
| Insomnia | 5.6% (15) | 5.4% (45) | 0.919 |
| Dry skin and mucous membranes | 4.5% (12) | 3.6% (30) | 0.526 |
| Nausea | 4.1% (11) | 3.4% (28) | 0.579 |
| Gastrointestinal upset | 3.0% (8) | 3.0% (25) | 0.977 |
| Dizziness | 3.0% (8) | 3.5% (29) | 0.684 |
| Diarrhoea | 2.6% (7) | 1.0% (8) | 0.044 |
| Myalgia | 2.2% (6) | 1.7% (14) | 0.560 |
AE, adverse events; DAA, direct-acting antiviral; DDIs, drug–drug interactions; SVR12, sustained virologic response week 12.