Table 19.
Efficacy of Epclusa® in phase 2 and 3 clinical trials.
| Cirrhosis | Prior treatment | SVR12 rate |
Study and trial phase | Ref. | |||||
|---|---|---|---|---|---|---|---|---|---|
| GT-1 | GT-2 | GT-3 | GT-4 | GT-5 | GT-6 | ||||
| 400 mg sofosbuvir + 100 mg velpatasvir fixed-dose, single pill, QD for 12w | |||||||||
| No cirrhosis | Experienced | 100% (20/20) | 100% (27/27) | GS-US-342-0109, phase 2 | Pianko et al., 2015 | ||||
| Naïve | 100% (28/28) | 100% (10/10) | 92.6% (25/27) | 85.7% (6/7) | 100% (5/5) | Phase 2 | Everson et al., 2015 | ||
| Naïve or experienced | 1a: 97.5% (157/161), 1b: 100% (94/94) |
100% (93/93) | 100% (89/89) | 96.6% (28/29) | 100% (35/35) | ASTRAL-1, phase 3 | Feld et al., 2015a | ||
| Naïve | 99% (99/100) | 98.2% (160/163) | ASTRAL-2, ASTRAL-3, phase 3 | Foster et al., 2015b | |||||
| Experienced | 100% (15/15) | 91.2% (31/34) | |||||||
| Cirrhosis |
Experienced | 100% (7/7) | 88.5% (23/26) | GS-US-342-0109, phase 2 | Pianko et al., 2015 | ||||
| Naïve or experienced | 1a:100% (49/49), 1b: 95.8% (23/24) |
100% (10/10) | 100% (27/27) | 100% (5/5) | 100% (6/6) | ASTRAL-1, phase 3 | Feld et al., 2015a | ||
| Naïve | 100% (15/15) | 93% (40/43) | ASTRAL-2, ASTRAL-3, phase 3 | Foster et al., 2015b | |||||
| Experienced | 100% (4/4) | 89.2% (33/37) | |||||||
| Naïve or experienced | 1a: 88% (44/50), 1b: 88.9% (16/18) |
100% (4/4) | 50% (7/14) | 100% (4/4) | ASTRAL-4, phase 3 | Curry et al., 2015 | |||
| 400 mg sofosbuvir + 100 mg velpatasvir fixed-dose, single pill, QD + ribavirin for 12w | |||||||||
| No cirrhosis | Experienced | 100% (18/18) | 100% (26/26) | GS-US-342-0109, phase 2 | Pianko et al., 2015 | ||||
| Cirrhosis | Experienced | 90% (9/10) | 96.2% (25/26) | GS-US-342-0109, phase 2 | Pianko et al., 2015 | ||||
| Naïve or Experienced | 1a: 94.4% (51/54), 1b: 100% (14/14) |
100% (4/4) | 84.6% (11/13) | 100% (2/2) | ASTRAL-4, phase 3 | Curry et al., 2015 | |||