Table 1.
Baseline Demographic and Clinical Characteristics of Patients With Chronic HCV Infection Receiving Sofosbuvir-Based Therapies in the ION, ASTRAL, and POLARIS Phase 3 Clinical Trials, by Receipt of Opioid Substitution Therapy
| Characteristic | OST at Enrollment (n = 194), n (%) |
No OST at Enrollment (n = 4549), n (%) |
|---|---|---|
| Mean (SD) age, y | 48 (10.7) | 54 (10.4) |
| Male sex, n (%) | 141 (73) | 2770 (61) |
| HCV genotype, n (%)a | ||
| 1a | 84 (43) | 2109 (46) |
| 1b | 12 (6) | 816 (18) |
| 2 | 14 (7) | 409 (9) |
| 3 | 74 (38) | 787 (17) |
| 4 | 10 (5) | 269 (6) |
| 5 | 0 | 54 (1) |
| 6 | 0 | 86 (2) |
| HCV RNA log10 IU/mL, mean (SD) | 6.3 (0.7) | 6.3 (0.7) |
| HCV RNA ≥ 800000 IU/mL, n (%) | 142 (73) | 3456 (76) |
| Fibrosis stage | ||
| F0 | 42 (22) | 826 (18) |
| F1 | 23 (12) | 410 (9) |
| F2 | 45 (24) | 1141 (25) |
| F3 | 30 (16) | 721 (16) |
| F4 | 51 (27) | 1410 (31) |
| Treatment-experienced, n (%) | 42 (22) | 1568 (34) |
| Therapy | ||
| Ledipasvir/sofosbuvir ± ribavirin (8 wk) | 8 (4) | 423 (9) |
| Ledipasvir/sofosbuvir ± ribavirin (12 wk) | 32 (16) | 835 (18) |
| Ledipasvir/sofosbuvir ± ribavirin (24 wk) | 13 (7) | 641 (14) |
| Sofosbuvir/velpatasvir (12 wk) | 92 (47) | 1643 (36) |
| Sofosbuvir/velpatasvir/voxilaprevir (8 wk) | 41 (21) | 570 (13) |
| Sofosbuvir/velpatasvir/voxilaprevir (12 wk) | 8 (4) | 437 (10) |
| OST, n (%) | ||
| Methadone | 113 (58) | - |
| Buprenorphine | 35 (18) | - |
| Buprenorphine/naloxone | 40 (21) | - |
| Other | 6 (3) | - |
Abbreviations: HCV, hepatitis C virus; OST, opioid substitution therapy.
aNineteen patients were classified as other, unknown, or missing, and all were not receiving OST at enrollment.