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. 2019 Oct 22;92(2):219–226. doi: 10.1002/jmv.25605

Table 2.

EBR/GZR‐related adverse events

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.