Table 2.
Adverse events (AE) (n)(%) | Overall (n = 149) | Cirrhosis (n = 79) | Noncirrhosis (n = 70) | P value |
---|---|---|---|---|
≧1 AEs | 44 (30.2) | 26 (32.9) | 18 (25.7) | .3365 |
Total bilirubin elevation | 11 (7.4) | 10 (12.7) | 1 (1.4) | .0089 |
Insomnia | 6 (4.0) | 3 (3.8) | 3 (4.3) | .8797 |
Dizziness | 6 (4.0) | 4 (5.1) | 2 (2.9) | .4942 |
Fatigue | 6 (4.0) | 2 (2.5) | 4 (5.7) | .3240 |
ALT elevation | 5 (3.4) | 3 (3.8) | 2 (2.9) | .7504 |
Headache | 4 (2.7) | 1 (1.3) | 3 (4.3) | .2550 |
Pruritus | 3 (2.0) | 2 (2.5) | 1 (1.4) | .6323 |
Skin reaction | 1 (0.7) | 1 (1.3) | 0 (0) | .3449 |
Nausea | 1 (0.7) | 0 (0) | 1 (1.4) | .2865 |
Dry mouth | 1 (0.7) | 0 (0) | 1 (1.4) | .2865 |
Management of AE, n (%) | ||||
Observation | 32 (21.5) | 18 (22.8) | 14 (20.0) | .6795 |
Medication | 9 (6.0) | 6 (7.6) | 3 (4.3) | .3974 |
Drug discontinuation | 3 (2.0) | 2 (2.5) | 1 (1.4) | .6323 |
Note: Total bilirubin normal range ≦ 1.3 mg/dL; ALT normal range ≦ 36 U/L.
Abbreviations: ALT, alanine aminotransferase; EBR/GZR, elbasvir/grazoprevir.