Table 12.
Efficacy of 90 mg ledipasvir + 400 mg sofosbuvir QD for 24 weeks, or with ribavirin for 12 weeks in phase 2 and 3 clinical trials.
| Cirrhosis | Prior treatment | SVR12 rate |
Study and trial phase | Ref. | ||
|---|---|---|---|---|---|---|
| GT-1 | GT-3 | GT-4 | ||||
| 90 mg ledipasvir + 400 mg sofosbuvir QD for 24 weeks | ||||||
| No cirrhosis | Naïve | 99.5% (181/182) | ION-1, phase 3 | Afdhal et al., 2014a | ||
| PI + PegIFNα+RBV | 97.2% (35/36) | ION-2, phase 3 | Afdhal et al., 2014b | |||
| PegIFNα+RBV | 100% (50/50) | |||||
| Cirrhosis |
Naïve | 96.9% (31/32) | ION-1, phase 3 | Afdhal et al., 2014a | ||
| Experienced | 96.1% (74/77) | SIRIUS, phase 2 | Bourliere et al., 2015 | |||
| PI + PegIFNα+RBV | 100% (14/14) | ION-2, phase 3 |
Afdhal et al., 2014b |
|||
| PegIFNα+RBV | 100% (8/8) | |||||
| 90 mg ledipasvir + 400 mg sofosbuvir QD with ribavirin for 12 weeks | ||||||
| No cirrhosis | Experienced | 100% (36/36) | Patients from 5 trials | Wyles et al., 2015 | ||
| Naïve | 100% (25/25) | Phase 2 | Gane et al., 2014a | |||
| Experienced | 100% (9/9) | |||||
| Experienced | 100% (10/10) | LONESTAR, phase 2 | Lawitz et al., 2014b | |||
| Experienced | 100% (7/7) | ELECTRON-1, phase 2 | Gane et al., 2013b | |||
| Naïve | 100% (20/20) | ELECTRON-2, phase 2 | Gane et al., 2015, Gane et al., 2013b | |||
| Experienced | 100% (19/19) | 89.3% (25/28) | ||||
| Naïve or experienced | 96.3% (52/54) | 100% (1/1) | SOLAR-1, phase 2 | Charlton et al., 2015b | ||
| Naïve or experienced | 93.3% (42/45) | 100% (7/7) | SOLAR-2, phase 2 | Manns et al., 2016 | ||
| Naïve | 100% (178/178) | ION-1, phase 3 | Afdhal et al., 2014a | |||
| PI + PegIFNα+RBV | 100% (51/51) | ION-2, phase 3 | Afdhal et al., 2014b | |||
| PegIFNα+RBV | 100% (38/38) | |||||
| Cirrhosis | Experienced | 97.4% (75/77) | SIRIUS, phase 2 | Bourliere et al., 2015 | ||
| Experienced | 100% (11/11) | LONESTAR, phase 2 | Lawitz et al., 2014b | |||
| Experienced | 100% (14/14) | Patients from 5 trials | Wyles et al., 2015 | |||
| Experienced | 100% (9/9) | Phase 2 | Gane et al., 2014a | |||
| Naïve or experienced | 87.3% (96/110) | 100% (3/3) | SOLAR-1, phase 2 | Charlton et al., 2015b | ||
| Naïve or experienced | 91.8% (90/98) | 77.8% (14/18) | SOLAR-2, phase 2 | Manns et al., 2016 | ||
| Experienced | 100% (27/27) | ELECTRON-1, phase 2 | Gane et al., 2013b | |||
| Naïve | 100% (20/20) | 100% (6/6) | ELECTRON-2, phase 2 | Gane et al., 2015, Gane et al., 2013b | ||
| Experienced | 72.7% (16/22) | |||||
| Naïve | 100% (33/33) | ION-1, phase 3 | Afdhal et al., 2014a | |||
| PI + PegIFNα+RBV | 84.6% (11/13) | ION-2, phase 3 | Afdhal et al., 2014b | |||
| PegIFNα+RBV | 77.8% (7/9) | |||||
| Experienced | 89.2% (132/148)a | 61.4% (35/57)a | Real-world study | Cheung et al., 2016 | ||
a
SVR24 rates were used in the study.