Table 11.
Efficacy of 90 mg ledipasvir + 400 mg sofosbuvir, QD for 12 weeks.
Cirrhosis | Prior treatment | SVR12 rate |
Study and trial phase | Ref. | ||||
---|---|---|---|---|---|---|---|---|
GT-1 | GT-3 | GT-4 | GT-5 | GT-6 | ||||
No cirrhosis |
Naïve | 94.7% (18/19) | LONESTAR, phase 2 | Lawitz et al., 2014b | ||||
Experienced | 100% (8/8) | |||||||
Naïve | 1a:100% (11/11), 1b:100% (9/9) | Phase 2a | Kohli et al., 2015a | |||||
Naïve or experienced | 92.9% (13/14) | NIAID, phase 2a | Kohli et al., 2015b | |||||
Naïve or experienced | 76.2% (16/21) | 95.7% (22/23) | ELECTRON-2, phase 2 | Gane et al., 2015 | ||||
Experienced | 100% (7/7) | SPARE, phase 2a | Osinusi et al., 2014 | |||||
Experienced | 91.2% (31/34) | NIAID synergy, phase 2a | Wilson et al., 2016 | |||||
Naïve | 95.2% (20/21) | Phase 2 | Abergel et al., 2016a | |||||
Experienced | 84.6% (11/13) | |||||||
Naïve | 94.4% (17/18) | Phase 2 | (Abergel et al., 2016b) | |||||
Experienced | 100% (14/14) | |||||||
Naïve | 100% (70/70) | GS-US-337-0113, phase 3 | Mizokami et al., 2015 | |||||
Experienced | 100% (60/60) | |||||||
Naïve | 100% (179/179) | ION-1, phase 3 | Afdhal et al., 2014a | |||||
Experienced | 96.2% (50/52) | ION-2, phase 3 | Afdhal et al., 2014b | |||||
Experienced | 94.3% (33/35) | |||||||
Naïve | 1a: 94.8% (163/172), 1b: 97.7% (43/44) | ION-3, phase 3 | Kowdley et al., 2014a | |||||
Naïve | 1a: 94.6% (406/429), 1b: 98.3% (172/175) | TRIO, real-world study | Younossi et al., 2016 | |||||
Naïve | 1a:95.7% (1352/1413), 1b:95.2% (415/436) | Real-world study |
Ioannou et al., 2016 |
|||||
Experienced | 1a:96.7% (472/488), 1b:95.6% (175/183) | |||||||
Cirrhosis | Experienced | 90.9% (10/11) | LONESTAR, phase 2 | Lawitz et al., 2014b | ||||
Naïve | 100% (1/1) | Phase 2 | Abergel et al., 2016a | |||||
Experienced | 100% (9/9) | |||||||
Naïve | 100% (3/3) | Phase 2 | Abergel et al., 2016b | |||||
Experienced | 83.3% (5/6) | |||||||
Null response | 70% (7/10) | Phase 2 | Gane et al., 2014a | |||||
Naïve or experienced | 100% (7/7) | NIAID, phase 2a | Kohli et al., 2015b | |||||
Experienced | 70% (7/10) | ELECTRON-1, phase 2 | Gane et al., 2013b | |||||
Naïve or experienced | 25% (1/4) | 100% (2/2) | ELECTRON-2, phase 2 | Gane et al., 2015 | ||||
Naïve | 96.9% (32/33) | ION-1, phase 3 | Afdhal et al., 2014a | |||||
PI + PegIFNα+RBV | 85.7% (12/14) | ION-2, phase 3 | Afdhal et al., 2014b | |||||
PegIFNα+RBV | 87.5% (7/8) | |||||||
Naïve | 100% (13/13) | GS-US-337-0113, phase 3 | Mizokami et al., 2015 | |||||
Experienced | 100% (28/28) | |||||||
Naïve | 1a:91.7% (483/527), 1b:93.6% (162/173) | Real-world study | Ioannou et al., 2016 | |||||
Experienced | 1a:90.7% (68/75), 1b:100% (38/38) | |||||||
Experienced | 76.9% (10/13) a | 40% (2/5)a | Real-world study | Cheung et al., 2016 |
SVR24 rates were evaluated in the clinical study.