Table 10.
Efficacy of 150 mg simeprevir QD plus PegIFNα/RBV for 12w + PegIFNα/RBV for 36w.
| Cirrhosis | Prior treatment | SVR12 rate |
Study and trial phase | Ref. | |
|---|---|---|---|---|---|
| GT-1 | GT-4 | ||||
| No cirrhosis |
Relapser | 87.3% (55/63) | ASPIRE, phase 2b | Zeuzem et al., 2014b | |
| Partial responder | 74.1% (43/58) | ||||
| Null responder | 59.5% (22/37) | ||||
| Naïve | 84.4% (27/32) | RESTOREa, phase 3 | Moreno et al., 2015 | ||
| Experienced | 59.2% (45/76) | ||||
| Naïve | 91% (132/145) | TIGER, phase 3 | Wei et al., 2016 | ||
| Cirrhosis | Relapser | 73.3% (11/15) | ASPIRE, phase 2b | Zeuzem et al., 2014b | |
| Partial responder | 81.8% (9/11) | ||||
| Null responder | 30.8% (4/13) | ||||
| Naïve | 66.7% (2/3) | RESTOREa, phase 3 | Moreno et al., 2015 | ||
| Experienced | 39.1% (18/46) | ||||
| Naïve | 100% (5/5) | TIGER, phase 3 | Wei et al., 2016 | ||
?: Question marks indicate that the data was unavailable in literature.
a
Patients in the RESTORE study received simeprevir plus PegIFNα/RBV for 12w followed by PegIFNα/RBV for either 12w or 36w (Moreno et al., 2015).