Table 2.
Characteristics of Included Studies.
| Author | Study | Experimental group | Control group | HCV gen | Patients | Age |
Men |
Race, N (%) | Cirrhosi |
IL28B genotype, N (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | Phase | Drug | Dose (mg) | Treatment duration (weeks) | N patients | Drugc | N patients | Median (range) | No (%) | White | Black | Others | No (%) | CC | CT | TT | |||
| Pearlman 2015 | – | 2 | SIM + SOF | 150 + 400 | 12 | 58 | SOF + PEG-IFNα-2b/RBV | 24 | 1a | Naive and previously treated | 56.5b | 53 (64.6) | 38 (46) | 39 (47) | 5 (6) | 82 (100) | No CC: 71 (86.6) | ||
| Reddy 2015 | ATTAIN | 3 | SIM + placebo + Peg-IFNα2a/RBV | 150 + 750 | 12 | 379 | Tel + placebo + PEG-IFNα2a/RBV | 384 | 1a 1b |
Previously treated | 51 (18–69) | 466 (61.1) | 719 (94.2) | 38 (5) | 6 (0.8) | 163 (21.4) | 33 (4.3) | 472 (61.8) | 223 (29.2) |
| Zeuzem 2014 | ASPIRE | 2b | SIM + PEG-IFN/RBV | 100 | 12 | 66 | Placebo + PEG-IFN/RBV | 61b6 | 1a 1b |
Previously treated | 50 (20–69) | 311 (67.3) | 428 (92) | 34 (7) | Na | 83 (18.2) | 58 (17.7) | 212 (64.6) | 58 (17.7) |
| 100 | 24 | 65 | |||||||||||||||||
| 100 | 48 | 66 | |||||||||||||||||
| 150 | 12 | 66 | |||||||||||||||||
| 150 | 24 | 68 | |||||||||||||||||
| 150 | 48 | 65 | |||||||||||||||||
| Hayashi 2014 | DRAGON | Nr | SIM + PEG-IFNα-2a/RBV | 50 | 12 | 27 | PEG-IFNα-2a/RBV | 13 | 1b | Naive | 54 (20–69) | 43 (47) | Na | Na | 92 (100) | 0 (0) | nr | nr | nr |
| 50 | 24 | 13 | |||||||||||||||||
| 100 | 12 | 26 | |||||||||||||||||
| 100 | 24 | 13 | |||||||||||||||||
| Forns 2014 | PROMISE | 3 | SIM + PEG-IFNα-2a/RBV | 150 | 12 | 260 | Placebo + PEG-IFNα-2a/RBV | 133 | 1a 1b |
Previously treated | 52 (20–71) | 258 (65.6) | 371 (94.4) | 11 (2.8) | Na | 0 (0) | 96 (24.4) | 250 (63.6) | 47 (12) |
| Hayashi 2014 | CONCERTO-I | 3 | SIM + PEG-IFNα-2a/RBV | 100 | 12 | 123 | Placebo + PEG-IFNα-2a/RBV | 60 | 1a 1b |
Naive | 55 (23–69) | 63 (34.4) | Nr | Nr | Nr | 0(0) | 121 (66) | 62 (34) | Na |
| Jacobson 2014 | QUEST-I | 3 | SIM + PEG-IFNα-2a/RBV | 100 | 12 | 264 | Placebo + PEG-IFNα-2a/RBV | 130 | 1a 1b |
Naive | 48 (36–54) | 222 (56.3) | 349 (88.6) | 31 (7.8) | 8 (2) | Na | 114 (28.9) | 226 (57.3) | 54 (13.7) |
| Manns 2014 | QUEST-II | 3 | SIM + PEG-IFNα-2a or 2b/RBV | 150 | 12 | 257 | Placebo + PEG-IFNα/RBV | 134 | 1a 1b |
Naive | 45 (18–73) | 217 (55.5) | 360 (92) | 26 (6.6) | 5 (1.2) | 32 (8) | 117 (30) | 213 (54.5) | 61 (15.6) |
| Fried 2013 | PILLAR | 2b | SIM + PEG-IFNα-2a | 75 | 12 | 78 | Placebo + PEG-IFNα-2a | 77 | 1a 1b |
Naive | 47 (18–69) | 213 (55.2) | 362 (93.8) | 13 (3.4) | 11 (2.8) | Na | 78 (20.2) | 152 (39.4) | 32 (8.3) |
| 75 | 24 | 75 | |||||||||||||||||
| 150 | 12 | 77 | |||||||||||||||||
| 150 | 24 | 79 | |||||||||||||||||
| Jacobson 2013 | POSITRONa | 3 | SOF + RBV | 400 | 12 | 207 | Placebo + RBV | 71 | 2; 3 | Previously treated | 52b (21–75) | 151 (54.3) | 254 (91.4) | 13 (4.6) | 11 (6.2) | 44 (15.8) | 126 (45.3) | 120 (43) | 32 (11.5) |
| Lawitz 2013 | – | 2 | SOF + PEG-IFNα-2a/RBV | 200 | 12 | 48 | Placebo + PEG-IFNα-2a/RBV | 26 | 1a 1b |
Naive | 48.4 | 73 (60.3) | 97 (80) | 18 (14.9) | 6 (5) | Na | 50 (41.3) | 54 (44.6) | 17 (14) |
| 400 | |||||||||||||||||||
| Dore 2015 | – | 2b | DACL + PEG-IFNα-2a/RBV | 60 | 12 | 50 | Placebo + PEG-IFNα-2a/RBV | 51 | 2; 3 | Naive | 48.6 (20–67) | 96 (63.6) | 129 (85.4) | 4 (2.6) | 18 (11.9) | 19 (12.6) | 56 (37) | 76 (50.3) | 17 (11.3) |
| 16 | 51 | ||||||||||||||||||
| Hezodè 2015 | COMMAND-1 | 2b | DACL + PEG-IFNα-2a/RBV | 20 | 12 | 159 | Placebo + PEG-IFNα-2a/RBV | 78 | 1a 1b 4 |
Naive | 50.5 (18–70) | 265 (67) | 319 (80.7) | 45 (11.4) | 31 (7.8) | 29 (7.3) | 120 (30.4) | 206 (52) | 46 (11.6) |
| 60 | 12 | 158 | |||||||||||||||||
| Kumada 2016 | – | 3b | DACL + ASU | 60 + 100 | 24 | 119 | Tel + placebo + PEG-IFNα2a/RBV | 111 | 1b | Naive | 56 (20–70) | 102 (44) | Nr | Nr | Nr | Na | 153 (66.5) | 70 (30.4) | 5 (2.2) |
| Izumi 2014 | – | 2a | DACL + PEG-IFNα-2a/RBV | 10 | 24 | 9 | Placebo + PEG-IFNα-2a/RBV | 8 | 1a 1b |
Naïve | 56 (28–67) | 9 (36) | Nr | Nr | Nr | 0 (0) | 19 (76) | 5 (20) | 0(0) |
| 60 | 24 | 8 | |||||||||||||||||
| Pol 2012 | – | 2a | DACL + PEG-IFNα-2a/RBV | 3 | 12 | 12 | Placebo + PEG-IFNα-2a/RBV | 12 | 1a 1b |
Naive | 51 (28–68) | 32 (66.6) | 35 (72.9) | 9 (18.7) | 4 (8.3) | Na | 13 (27) | 18 (37.5) | 5 (10.4) |
| 10 | 12 | ||||||||||||||||||
| 60 | 12 | ||||||||||||||||||
| Bronowicki 2014 | – | 2b | ASU + PEG-IFNα-2a/RBV | 200 | 24 | 177 | Placebo + PEG-IFNα-2a/RBV | 61 | 1a 1b 4 |
Naive | 47.8 | 153 (64.3) | 199 (83.6) | 20 (8.4) | 19(8) | 25 (10.5) | 66 (27.7) | 128 (53.7) | 36 (15.1) |
| Bronowicki 2013 | – | 2a | ASU + PEG-IFNα-2a/RBV | 200 | 48 | 12 | Placebo + PEG-IFNα-2a/RBV | 11 | 1a 1b |
Naive | 48 | 35 (74.4) | 38 (80.8) | 8 (17) | 1 (2) | Na | 13 (27.6) | 24 (51) | 10 (21) |
| 600 twice d | |||||||||||||||||||
| 600 once d | |||||||||||||||||||
| Rodriguez-Torres 2014 | – | 2b | FIL + PEG-IFNα-2a/RBV | 300 | 24 | 96 | Placebo + PEG-IFNα-2a/RBV | 96 | 1 | Naive | 47.8 (10) | 153 (53) | 227 (78.8). | 18 (6.2) | 43 (14.9)- | Na | 63 (21.8) | 106 (368) | 27 (9.3) |
| 600 | |||||||||||||||||||
| Manns 2014 | – | 2 | GRAZ (MK-5172) + PEG-IFNα-2b/RBV | 100 | 12 | 66 | Placebo + BOC + PEG-IFNα-2b/RBV | 66 | 1b | Naive | 51b (18–72) | 191 (57.5) | 272 (81.9) | 44 (13.2) | 16 (4.8) | Na | Nr | Nr | Nr |
| 200 | 68 | ||||||||||||||||||
| 400 | 67 | ||||||||||||||||||
| 800 | 65 | ||||||||||||||||||
| Sulkowski 2013 | SILENC-1 | 2b | FAL + PEG-IFNα -2a/RBV | 120 | 24 | 69 | Placebo + PEG-IFNα-2a/RBV | 71 | 1a 1b |
Naive | 46b (SD 10.5) | 234 (54) | 356 (82.9) | 10 (2.3) | 63 (14.6) | Na | 60 (14) | no CC 163 (38) | |
| 240 | 143 | ||||||||||||||||||
| 240 | 146 | ||||||||||||||||||
| Ferenci 2015 | STARTVerson 1 | 3 | FAL + PEG-IFNα -2a/RBV | 120 | 12 | 259 | Placebo + PEG-IFNa2a/RBV | 132 | 1a 1b |
Naive | 47,6b | 342 (52.4) | 511 (78.4) | 9 (1.4) | 132 (20.2) | 30 (6) | 254 (38.9) | 316 (48.4) | 81 (12.4) |
| 240 | 261 | ||||||||||||||||||
| Marcellin 2013 | ATLAS | 2 | DAN +PEG-IFNα-2a/RBV | 300 | 12 | 72 | Placebo + PEG-IFNα-2a/RBV | 31 | 1a 1b |
Naive | 48.3 | 135 (60) | 193 (85.7) | 22 (9.7) | 10 (4.4) | Na | 56 (24.8) | Nr | Nr |
| 600 | 72 | ||||||||||||||||||
| 900 | 50 | ||||||||||||||||||
| Everson 2015 | DAUPHINE | 2 | DAN/r + PEG-IFNα-a/RBV | 200/100 | 24 | 92 | Placebo + PEG-IFNα-2a/RBV | 44 | 1a 1b 4 |
Naive | 52.5 (19–73) | 202 (62.5) | 259 (80) | 34 (10.5) | 30 (9.3) | Na | 94 (29.1) | No CC 229 (70.9) | |
| 100/100 | 93 | ||||||||||||||||||
| 50/100 | 94 | ||||||||||||||||||
| Hayashi 2015 | – | 3 | VAN + PEG-IFNα-a/RBV | 300 | 12 | 98 | Placebo + PEG-IFNα-2b/RBV | 98 | 1a 1b |
Naive | Nr | 137 (46.6) | Nr | Nr | Nr | Na | 198 (67.3) | 92 (31.3) | 4 (1.4) |
| 24 | 98 | ||||||||||||||||||
| Lawitz 2013 | – | 2b | VAN + PEG-IFNα-a/RBV | 300 | 48 | 41 | Placebo + PEG-IFNα-2a/RBV | 42 | 1a 1b |
Previously treated | 51 (23–65) | 82 (67.2) | 95 (77.8) | 7 (5.7) | 23 (18.9) | 0 (0) | Nr | Nr | Nr |
| 600 | 42 | ||||||||||||||||||
| Rodriguez-torres 2014 | – | 2b | VAN + PEG-IFNα-2a/RBV | 300 | 24 | 13 | Placebo + PEG-IFNα-2a/RBV | 14 | 1a 1b |
Previously treated | 55.5 (38–65) | 49 (66.2) | 65 (87.8) | 4 (5.4) | 5(6.7) | 74 (100) | nr | nr | nr |
| 300 | 48 | 13 | |||||||||||||||||
| 600 | 24 | 15 | |||||||||||||||||
| 600 | 48 | 15 | |||||||||||||||||
| Dore 2016 | MALACHITE I/II | 3b | OBV/PTV/r + DAS + RBV | 25 | 12 or 16 | 337 | Tel + placebo + PEG-IFNα2a/RBV | 122 | 1a 1b |
Naive and previously treated | 46b | 243 (52.9) | 440 (95.9) | (0) | 59 (12.8) | Nr | 79 (17.9) | no CC 380 (82.8) | |
| 100 | |||||||||||||||||||
| 150 | |||||||||||||||||||
| 250 | |||||||||||||||||||
ASU, asunaprevir; BOC, boceprevir; DACL, daclatasvir; DAN, danoprevir; DAS, dasabuvir; FAL, faldaprevir; FIL, filibuvir; GRAZ, grazoprevir; IFN, interferone; n, number; nr, not reported; na, not available; OBV/PTV/r, ombitasvir/paritaprevir, ritonavir; RBV, ribavirin; SIM, simeprevir; SOF, sofosbuvir; Tel, telaprevir; VAN, vanoprevir.
a
Authors reported also the FUSION study results, administering sofosbuvir in all study arms.
b
Results reported as mean.
c
Dosage of PEG-IFNα/RBV was 180 μg/1000–1200 mg in all studies included.