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Table 4 Safety summary

From: Sofosbuvir/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real-world setting in Taiwan

Event, N (%)

FIB-4 ≤ 3.25 (N = 635)

FIB-4 > 3.25 (N = 188)

p value

Adverse events, > 3%

77 (12.1)

28 (15)

0.38

Abdominal discomfort

28 (4.4)

11 (5.9)

0.53

 Fatigue

26 (4.1)

11 (5.9)

0.41

 Skin itching

23 (3.6)

6 (3.2)

0.96

Laboratory adverse event

14 (2.2)

32 (17)

 < 0.001

 Total bilirubin elevation

6 (0.9)

21 (11.2)

 < 0.001

 1.5–3 × ULN

6 (0.9)

15 (8)

 < 0.001

  > 3 × ULN

0

6 (3.2)

 < 0.001

AST elevation

3 (0.5)

8 (4.3)

 < 0.001

 3–5 × ULN

3 (0.5)

6 (3.2)

 < 0.001

  > 5 × ULN

0

2 (1.1)

0.05

ALT elevation

5 (0.8)

3 (1.6)

0.39

 3–5 X ULN

3 (0.5)

2 (1.1)

0.32

  > 5 × ULN

2 (0.3)

1 (0.5)

0.54

  1. p value in italics indicates statistical nonsignificance between the two groups