Table 18.
Efficacy of Zepatier™ with or without ribavirin in phase 2 and 3 clinical trials.
| Cirrhosis | Prior treatment | SVR12 rate |
Study and trial phase * | Ref. | ||||
|---|---|---|---|---|---|---|---|---|
| GT-1 | GT-2 | GT-4 | GT-5 | GT-6 | ||||
| 100 mg grazoprevir QD + 50 mg elbasvir QD for 12w | ||||||||
| No cirrhosis | Naïve | 97.7% (43/44) | C-WORTHY, phase 2 | Sulkowski et al., 2015 | ||||
| Experienced | 89.5% (17/19) | Lawitz et al., 2015d | ||||||
| Naïve | 1a: 91.7% (144/157), 1b: 97.9% (95/97) |
100% (16/16) | 80% (8/10) | C-EDGE, phase 3 | Zeuzem et al., 2015a | |||
| Naïve | 100% (92/92) | C-SURFER, phase 3 | Roth et al., 2015 | |||||
| Experienced | 94.4% (17/18) | |||||||
| Naïve or Experienced | ? | ? | C-EDGE Head-2-Head, phase 3 | Sperl et al., 2016 | ||||
| Naïve | 1a: 94.5% (104/110), 1b: 90.9% (20/22) |
87.5% (7/8) | 20% (1/5) | C-EDGE CO-STAR, phase 3 | Dore et al., 2016b | |||
| Naïve | 90% (9/10) | 25% (1/4) | 75% (3/4) | C-SCAPE, phase 2 | Brown et al., 2015 | |||
| Cirrhosis |
Naïve | 96.6% (28/29) | C-WORTHY, phase 2 | Lawitz et al., 2015d | ||||
| Null response | 92.9% (13/14) | |||||||
| Naïve | 100% (4/4) | C-SURFER, phase 3 | Roth et al., 2015 | |||||
| Experienced | 100% (2/2) | |||||||
| Naïve or Experienced | ? | ? | C-EDGE Head-2-Head, phase 3 | Sperl et al., 2016 | ||||
| Naïve | 1a: 93.3% (28/30), 1b: 100% (6/6) |
100% (4/4) | C-EDGE CO-STAR, phase 3 | Dore et al., 2016b | ||||
| Naïve | 1a: 94.1% (32/34), 1b: 100% (34/34) |
100% (2/2) | C-EDGE, phase 3 | Zeuzem et al., 2015a | ||||
| 100 mg grazoprevir QD + 50 mg elbasvir QD + ribavirin BID for 12w | ||||||||
| No cirrhosis | Experienced | 95.2% (20/21) | C-WORTHY, phase 2 | Lawitz et al., 2015d | ||||
| Naïve | 92.9% (79/85) | Sulkowski et al., 2015 | ||||||
| Naïve | 80% (24/30) | 100% (10/10) | 100% (4/4) | 75% (3/4) | C-SCAPE, phase 2 | Brown et al., 2015 | ||
| PI-treated | 97.7% (43/44) | C-SALVAGE, phase 2 | Forns et al., 2015b | |||||
| Cirrhosis |
PI-treated | 94.1% (32/34) | ||||||
| Naïve | 96.9% (31/32) | C-WORTHY, phase 2 |
Lawitz et al., 2015d |
|||||
| Null response | 90.9% (10/11) | |||||||
| 100 mg grazoprevir QD + 50 mg elbasvir QD + ribavirin BID for 16w | ||||||||
| No cirrhosis | Null or partial response to PegIFNα/RBV | ? | ? | C-EDGE TE, phase 3 | Kwo et al., 2017 | |||
| Cirrhosis | ? | ? | ||||||
?: Question marks indicate that the SVR12 data was unavailable in literature.