Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis
Table 4
Discontinuations and AEs by treatment regimen.
Variables
GZR-EBR
GZR-EBR + RBV
Total ()
12 weeks ()
18 weeks ()
Total (
12 weeks ()
18 weeks ()
Discontinuation because of AE
3 (<1)
3 (<1)
0
1.000
4(1)
3 (1)
1 (2)
1.000
Any SAE
13 (3)
12 (3)
1 (2)
1.000
8(3)
7 (3)
1 (2)
0.690
Treatment-related SAE
1 (<1)
0
1 (2)
0.130
1(<1)
1 (<1)
0
1.000
Common AEs
At least one adverse event
344 (71)
293 (70)
51 (81)
0.064
236 (81)
177 (78)
59 (91)
0.018
Fatigue
86 (18)
73 (17)
13 (21)
0.523
84 (29)
60 (26)
24 (37)
0.095
Headache
98 (20)
78 (19)
20 (32)
0.015
60 (20)
43 (19)
17 (26)
0.199
Nausea
41 (8)
37 (9)
4 (6)
0.517
41 (14)
32 (14)
9 (14)
0.969
Asthenia
18 (4)
9 (2)
9 (14)
<0.001
35 (12)
24 (11)
11 (17)
0.161
AEs: adverse events. They were compared in GZR-EBR treated patients between 12 weeks and 18 weeks. They were compared in GZR-EBR + RBV treated patients between 12 weeks and 18 weeks.