Table 3

Effectiveness and safety according with DAA

CharacteristicTotal n=76 % (n; CI95%)Patients SOF/VEL±RBV n=46Patients GLE/PIB n=30P-value
Virologic response
 SVR12 (main)96,1 (73; 88.9 to 99.2)95.7% (44)96,7% (29)0.7
 Relapse3,9 (3; 0.82 to 11.1)4,3% (2)3,3% (1)
 Treatment failure0.0 (0)0.0% (0)0.0% (0)>0.99
 Virologic failure0.0 (0)0.0% (0)0.0% (0)>0.99
 Missing date0.0 (0)0.0% (0)0.0% (0)>0.99
Any grade drug-related AE21.1 (16; 11.3 to 30.9)26,1% (12)13,3% (4)0.3
Moderate drug-related AE9.2 (7; 2.1 to 16.4)8,7% (4)10.0% (3)0.83
Any grade AE with global incidence>1.0%:
 Fatigue/asthenia15.8 (12; 6.9 to 24.7)17,4% (8)13,3% (4)0.88
 Insomnia2.6 (2; 0.3 to 9.2)2,2% (1)3,3% (1)0.67
 Gastrointestinal upset1.3 (1; 0.0 to 7.1)0,0% (0)2,2% (1)0.83
 Headache1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Anxiety1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Diarrhoea1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Irritability1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Constipation1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Ocular pain1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Blurry vision1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Dry skin1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
 Dizziness1.3 (1; 0.0 to 7.1)2,2% (1)0.0% (0)0.83
  • AE, adverse event; DAA, direct-acting antiviral; GLE/PIB, glecaprevir/pibrentasvir; SOF/VEL±RBV, sofosbuvir/velpatasvir±ribavirin; SVR12, sustained virologic response week 12.