Table 8.
Efficacy of 150 mg simeprevir plus 400 mg sofosbuvir QD for 12w.
| Cirrhosis | Prior treatment | SVR12 rate |
Study and trial phase | Ref. | |
|---|---|---|---|---|---|
| GT-1 | GT-4 | ||||
| 150 mg simeprevir plus 400 mg sofosbuvir QD for 12w | |||||
| No cirrhosis |
Naïve | 100% (4/4) | COSMOS, phase 3 |
(Lawitz et al., 2014a) | |
| Null response | 94.1% (16/17) | ||||
| Naïve | 97.4% (112/115) | OPTIMIST-1, phase 3 | (Kwo et al., 2016) | ||
| Experienced | 95% (38/40) | ||||
| Naïve | 98.3% (285/290) | HCV-TARGET, phase 3 | (El-Khayat et al., 2016) | ||
| Experienced | 97.4% (191/196) | ||||
| Naïve | 100% (11/11) | GALAXY, phase 2 | (O'Leary et al., 2017) | ||
| Naïve | 1a:88.4% (61/69), 1b:97.4% (37/38) | HCV-TARGET, phase 3 |
(Sulkowski et al., 2016) |
||
| Experienced | 1a:89.5% (77/86), 1b:94.4% (51/54) | ||||
| Cirrhosis |
Naïve | 66.6% (2/3) | COSMOS, phase 3 |
(Lawitz et al., 2014a) | |
| Null response | 100% (4/4) | ||||
| Naïve | 88% (44/50) | OPTIMIST-2, phase 3 | (Lawitz et al., 2016a) | ||
| Experienced | 79.2% (42/53) | ||||
| Naïve | 80.8% (42/52) | HCV-TARGET, phase 3 | (El-Khayat et al., 2016) | ||
| Experienced | 88.9% (40/45) | ||||
| Naïve | 1a:83.9% (73/87), 1b:91.7% (33/36) | HCV-TARGET, phase 3 | (Sulkowski et al., 2016) | ||
| Experienced | 1a:75.2% (97/129), 1b:82.1% (64/78) | ||||
| Experienced | 1a:81.8% (9/11), 1b:100% (3/3) | 100% (2/2) | ANRS CO22 HEPATHER | (Hezode et al., 2016) | |
| Naïve or experienced |
80.8% (97/120) |
Real-world study |
(Shiffman et al., 2015) |
||
| 150 mg simeprevir plus 400 mg sofosbuvir QD for 24w | |||||
| No cirrhosis |
Naïve | 100% (2/2) | COSMOS, phase 3 |
(Lawitz et al., 2014a) | |
| Null response | 100% (18/19) | ||||
| Naïve | 100%(11/11) | GALAXY, phase 2 | (O'Leary et al., 2017) | ||
| Cirrhosis | Naïve | 100% (6/6) | COSMOS, phase 3 |
(Lawitz et al., 2014a) | |
| Null Response | 100% (4/4) | ||||