Table 1.
Baseline demographics and disease characteristics
| Characteristic | Treatment‐naïve | Treatment‐experienced | ||||
|---|---|---|---|---|---|---|
| Without cirrhosis | Cirrhosis | Without cirrhosis | Cirrhosis | |||
| 8 weeks N = 208 | 12 weeks N = 294 | 12 weeks N = 69 | 12 weeks N = 49 | 16 weeks N = 22 | 16 weeks N = 51 | |
| Male, n (%) | 123 (59) | 167 (57) | 41 (59) | 32 (65) | 14 (64) | 38 (75) |
| Race, n (%) | ||||||
| White | 180 (87) | 258 (88) | 64 (93) | 42 (86) | 20 (91) | 45 (88) |
| Asian | 14 (7) | 20 (7) | 2 (3) | 7 (14) | 2 (9) | 4 (8) |
| Black or African American | 6 (3) | 4 (1) | 1 (1) | 0 | 0 | 0 |
| Age, median years (range) | 46 (20‐76) | 49 (22‐71) | 56 (35‐70) | 56 (25‐68) | 59 (29‐66) | 59 (47‐70) |
| BMI, median kg/m2 (range) | 25 (18‐44) | 25 (17‐49) | 28 (19‐51) | 26 (19‐42) | 28 (22‐48) | 27 (21‐42) |
| HCV RNA, median log10 IU/mL (range) | 6.1 (1.2‐7.5) | 6.2 (3.4‐7.6) | 6.2 (4.2‐7.2) | 6.5 (5.1‐7.6) | 6.1 (4.7‐7.3) | 6.5 (4.6‐7.2) |
| Prior treatment experience, n (%) | ||||||
| PegIFN/RBV‐based | – | – | – | 41 (84) | 13 (59) | 26 (51) |
| SOF‐based | – | – | – | 8 (16) | 9 (41) | 25 (49) |
| History of injection drug use, n (%) | 141 (68) | 186 (63) | 51 (74) | 25 (51) | 13 (59) | 25 (49) |
| Recenta drug use | 20 (16) | 20 (12) | 0 | 0 | – | 0 |
| Opioid substitution therapy, n (%) | 38 (18) | 46 (16) | 11 (16) | 4 (8) | 0 | 2 (4) |
| HCV GT3 subtype, n (%) | ||||||
| 3a | 206 (99) | 291 (99) | 68 (99) | 48 (98) | 20 (91) | 50 (98) |
| 3b | 2 (1) | 1 (<1) | 1 (1) | 1 (2) | 1 (5) | 1 (2) |
| 3 g/i | 0 | 2 (1) | 0 | 0 | 1 (5) | 0 |
| Cirrhosis, n (%) | 0 | 0 | 69 (100) | 0 | 0 | 51 (100) |
| Baseline fibrosis stage, n (%) | ||||||
| F0‐F2 | 170 (82) | 263 (89) | 0 | 36 (73) | 17 (87) | 0 |
| F3 | 38 (18) | 31 (11) | 1 (1)b | 13 (27) | 5 (23) | 0 |
| F4 | 0 | 0 | 68 (99) | 0 | 0 | 51 (100) |
| CKD Stage 4 or 5, n (%) | 0 | 11 (4) | 1 (2) | 0 | NA | 0 |
| HIV coinfection, n (%) | 22 (11) | 0 | 4 (6) | 0 | NA | 0 |
| Post–liver or post–kidney transplant, n (%) | 0 | 24 (8) | 0 | 0 | NA | 0 |
| Geographic region, n (%) | ||||||
| North America | 71 (34) | 110 (37) | 49 (71) | 21 (43) | 15 (68) | 33 (65) |
| Europe | 99 (48) | 108 (37) | 5 (7) | 6 (12) | 1 (5) | 2 (4) |
| Rest of world | 38 (18) | 76 (26) | 15 (22) | 22 (45) | 6 (27) | 16 (31) |
| Presence of baseline polymorphismsc, n/N (%) | ||||||
| None | 146/206 (71) | 234/289 (81) | 52/68 (76) | 38/49 (78) | 18/21 (86) | 43/51 (84) |
| NS3/4A | 2/206 (1) | 5/289 (2) | 3/68 (4) | 0 | 0 | 1/51 (2) |
| NS5A | 60/206 (29) | 53/289 (18) | 13/68 (19) | 11/49 (22) | 3/21 (14) | 7/51 (14) |
| A30K | 19 (9) | 15 (5) | 1 (1) | 4 (8) | 1 (5) | 0 |
| Y93H | 10 (5) | 14 (5) | 5 (7) | 4 (8) | 0 | 1 (2) |
BMI, body mass index; CKD, chronic kidney disease; GT, genotype; HCV, hepatitis C virus; HIV, human immunodeficiency virus.
a
<12 months prior to screening; recent drug use data were not captured for patients enrolled in SURVEYOR‐2.
b
Patient was enrolled as cirrhotic by the investigator.
c
Includes patients with available baseline NS3 or NS5A sequence data; amino acid positions included in the analysis: 155, 156 and 168 in NS3 and 24, 28, 30, 31, 58, 92 and 93 in NS5A.