| |
Number of patients with event/total number of patients (%)
|
Relative risk (95 % CI)
|
Risk difference (95 % CI)
|
|---|
| |
Simeprevir + PegIFNα-2a + RBV
|
PegIFNα-2a + RBV
|
|---|
|
Efficacy
|
|
SVR24 (random effects)
|
77/106 (72.6 %)
|
104/369 (28.2 %)
|
2.58 (2.11; 3.15)
|
0.45 (0.34; 0.55)
|
|
SVR24 (fixed effects)
|
364/1313 (27.7 %)
|
2.62 (2.27; 3.03)
|
0.45 (0.36; 0.54)
|
|
Safety
|
|
At least one AEa
|
103/106 (97.2 %)
|
396/410 (96.6 %)
|
1.01 (0.97; 1.04)
|
0.01 (−0.04; 0.05)
|
|
At least one SAEa
|
11/106 (10.4 %)
|
67/407 (16.5 %)
|
0.63 (0.35; 1.15)
|
−0.06 (−0.14; 0.01)
|
|
AEs leading to discontinuationb
|
5/106 (4.7 %)
|
21/135 (15.6 %)
|
0.30 (0.12; 0.78)
|
−0.11 (−0.19; −0.03)
|
|
Anemia AEs (random effects)
|
35/106 (33.0 %)
|
58/202 (28.7 %)
|
1.15 (0.81; 1.63)
|
0.04 (−0.07; 0.16)
|
|
Anemia AEs (fixed effects)
|
124/418 (29.7 %)
|
1.11 (0.82; 1.52)
|
0.03 (−0.07; 0.14)
|
|
Psychiatric disorders AEsc
|
63/106 (59.4 %)
|
3/10 (30.0 %)
|
1.98 (0.76; 5.17)
|
0.29 (−0.06; 0.65)
|
- aNo difference between random and fixed effects models
- bResults for PegIFNα-2a + RBV from Torres-Cornejo 2014 [18]
- cResults for PegIFNα-2a + RBV from Murphy 2011 [15]
- CI confidence interval, SVR24 sustained virologic response 24 weeks after planned end of treatment, AE adverse event, SAE serious adverse event, RBV ribavirin, PegIFNα-2a peginterferon-alpha-2a
