TABLE 1.
Baseline characteristics of treated participants as randomized to EBR/GZR and LDV/SOF
| EBR/GZR | LDV/SOF | |
|---|---|---|
| Participants who started treatment, n | 700 | 428 |
| Age, years mean (range) | 53.4 (18.0–83.0) | 56.4 (21.0–82.0) |
| Sex, n (%) | ||
| Female | 293 (41.9) | 163 (38.1) |
| Male | 407 (58.1) | 265 (61.9) |
| Race, n (%) | ||
| White | 349 (49.9) | 225 (52.6) |
| Black | 295 (42.1) | 182 (42.5) |
| Other | 56 (8.0) | 21 (4.9) |
| HCV genotype 1 subtype, n (%) | ||
| 1a | 540 (77.1) | 317 (74.1) |
| 1b | 160 (22.9) | 111 (25.9) |
| Cirrhosis, n (%) | ||
| Yes | 112 (16.0) | 80 (18.7) |
| No | 588 (84.0) | 348 (81.3) |
| NS5A RAS, n (%) | ||
| RAS at any 28/30/31/93 | 69 (9.9) | 54 (12.6) |
| RAS at 28 only | 28 (4.0) | 14 (3.3) |
| RAS at 30 only | 4 (0.6) | 2 (0.5) |
| RAS at 31 only | 8 (1.1) | 14 (3.3) |
| RAS at 93 only | 21 (3.0) | 14 (3.3) |
| RBV administration, n (%) | ||
| Yes | 56 (8.0) | 15 (3.5) |
| No | 644 (92.0) | 413 (96.5) |
| HIV coinfection, n (%) | ||
| Yes | 22 (3.1) | 13 (3.0) |
| HCC history, n (%) | ||
| Yes | 4 (0.6) | 2 (0.5) |
| Type of health insurance, n (%) | ||
| Medicaid | 331 (47.3) | 113 (26.4) |
| Medicare | 98 (14.0) | 90 (21.0) |
| Commercial | 231 (33.0) | 186 (43.5) |
| Other | 40 (5.7) | 39 (9.1) |
| Platelets (1,000/mL), mean (range) | 222 (39.0–645.0) | 216 (67.0–343.0) |
| Duration of therapy, n (%) | ||
| 8 weeks (42–69 days) | 28 (4) | 110 (26) |
| 12 weeks (70–97 days) | 562 (80) | 275 (64) |
| 16 weeks (98–125 days) | 78 (11) | 9 (2.1) |
| Other Durations | 32 (4.5) | 34 (7.9) |
| Alcohol/tobacco use, n (%) | ||
| Current | 245 (35.0)/348 (49.7) | 159 (37.1)/168 (39.3) |
| Former | 166 (23.7)/193 (27.6) | 99 (23.1)/150 (35.0) |
| Never | 265 (37.9)/134 (19.1) | 157 (36.7)/94 (22.0) |
| Unknown | 24 (3.4)/26 (3.6) | 13 (3.0)/16 (3.7) |
Of the 428 randomized to LDV/SOF, 20 experienced insurance denial and were then treated with EBR/GZR instead.