Table 2.
Efficacy of pangenotypic regimens in phase III of clinical trials
|
Ref.
|
Number of participants
|
Regimen
|
GT
|
SVR (mITT analysis) n/N (%)
|
|||
|
Patients without cirrhosis
|
Patients with cirrhosis
|
||||||
|
Treatment-naïve
|
Treatment-experienced
|
Treatment-naïve
|
Treatment-experienced
|
||||
| Lawitz et al[60] (FISSION) | 256 | SOF + RBV, 12 wk | 1-3 | 147/204 (72.1) | 23/49 (46.9) | ||
| Jacobson et al[61] (FUSION) | 201 | SOF + RBV, 12 wk (n = 103) | 2, 3 | 25/26 (96.2), 14/38 (36.8) | 6/10 (60.0), 5/26 (19.2) | ||
| SOF + RBV, 16 wk (n = 98) | 2, 3 | 23/23 (100), 25/40 (62.5) | 7/9 (77.8), 14/23 (60.9) | ||||
| Jacobson et al[61] (POSITION) | 207 | SOF + RBV, 12 wk | 2 | 85/92 (92.0%) | 16/17 (94.0%) | ||
| 3 | 57/84 (68.0%) | 3/14 (21.0%) | |||||
| Zeuzem et al[81] (VALENCE)1 | 323 | SOF + RBV, 12 wk (n = 73) | 2 | 29/30 (96.7) | 30/32 (93.8) | 2/2 (100) | 7/9 (77.8) |
| SOF + RBV, 24 wk (n = 250) | 3 | 87/92 (94.6) | 85/98 (86.7) | 12/13 (92.3) | 29/47 (61.7) | ||
| Omata et al[82] | 153 | SOF + RBV, 12 wk | 2 | 80/82 (95.0) | 52/54 (100) | 8/8 (100) | 8/9 (89.0) |
| Foster et al[62] (BOSON)1 | 363 | SOF + RBV, 16 wk | 3 | 58/70 (83.0) | 41/54 (76.0) | 12/21 (57.0) | 17/36 (47.0) |
| SOF + RBV, 24 wk | 65/72 (90.0) | 44/54 (81.0) | 18/22 (82.0) | 26/34 (76.0) | |||
| Satsangi et al[83] | 105 | SOF + RBV, 24 wk | 3 | 49/49 (100) | 1/1 (100) | 22/23 (95.6) | 3/3 (100) |
| Nelson et al[65] (ALLY-3) | 152 | DCV + SOF, 12 wk | 3 | 105/109 (96.0) | 20/32 (63.0) | ||
| 73/75 (97.0) | 32/34 (94.0) | 11/19 (58.0) | 9/13 (69.0) | ||||
| Feld et al[67] (ASTRAL-1) | 624 | SOF/VEL, 12 wk | 1, 2, 4, 5, 6 | 496/501 (99.0) | 120/121 (99.2) | ||
| Foster et al[68] (ASTRAL-2) | 266 | SOF/VEL, 12 wk (n = 134) | 2 | 133/134 (99.0) | |||
| SOF + RBV, 12 wk (n = 132) | 124/132 (94.0) | ||||||
| Foster et al[68] (ASTRAL-3) | 552 | SOF/VEL, 12 wk (n = 277) | 3 | 160/163 (98.0) | 31/34 (91.0) | 40/43 (93.0) | 33/37 (89.0) |
| SOF + RBV, 24 wk (n = 275) | 141/156 (90.0) | 22/31 (71.0) | 33/45 (73.0) | 22/38 (58.0) | |||
| Curry et al[69] (ASTRAL-4) | 267 | SOF/VEL, 12 wk (n = 90) | 1-6 | 75/89 (84.3) | |||
| SOF/VEL + RBV 12 wk (n = 87) | 82/87 (94.0) | ||||||
| SOF/VEL, 24 wk (n = 90) | 77/87 (88.5) | ||||||
| Forns et al[73] (EXPEDITION-1) | 146 | GLE/PIB, 12 wk | 1, 2, 4, 5 or 6 | 145/146 (99.0) | |||
| Zeuzem et al[81] (ENDURANCE-1) | 703 | GLE/PIB, 8 wk (n = 351) | 1 | 343/344 (99.7) | |||
| GLE/PIB, 12 wk (n = 352) | 345/345 (100) | ||||||
| Zeuzem et al[72] (ENDURANCE-3) | 505 | GLE/PIB, 12 wk (n = 233) | 3 | 214/217 (99.0) | |||
| SOF + DCV, 12 wk (n = 115) | 110/111 (99.0) | ||||||
| GLE/PIB, 8 wk (n = 157) | 143/149 (96.0) | ||||||
| Asselah et al[74] (ENDURANCE-2) | 202 | GLE/PIB, 12 wk | 2 | 192/192 (100) | |||
| Asselah et al[74] (ENDURANCE-4) | 121 | GLE/PIB, 12 wk | 4-6 | 120/120 (100) | |||
| Brown et al[76] (EXPEDITION-8) | 343 | GLE/PIB, 8 wk | 1-6 | 334/335 (99.7) | |||
| Gane et al[78] (EXPEDITION-4) | 104 | GLE/PIB, 12 wk | 1-6 | 102/104 (98.0) | |||
| Bourlière et al[84] (POLARIS-1)1 | 263 | SOF/VEL/VOX, 12 wk | 1-6 | 253/263 (96.0)2 | |||
| Bourlière et al[84] (POLARIS-4)1 | 182 | SOF/VEL/VOX, 12 wk | 1-4 | 178/182 (98.0)2 | |||
1
Intent-to-treat analysis (no data for modified intent-to-treat analysis).
2
All analyzed patients were previously treated with a direct-acting antiviral-containing regimen.
DCV: Daclatasvir; GLE: Glecaprevir; GT: Genotype; mITT: Modified intention-to-treat; PIB: Pibrentasvir; RBV: Ribavirin; SOF: Sofosbuvir; SVR: Sustained virological response; VEL: Velpatasvir; VOX: Voxilaprevir.