Table 2.
Baseline demographics in patients with virologic failure
| Characteristic | Virologic failure at PTW12 N = 69 n (%) |
|---|---|
| Male | 51 (74) |
| Race | |
| White | 45 (65) |
| Black or African American | 1 (1) |
| Asian | 23 (33) |
| Age ≥ 65 years | 8 (12) |
| BMI (kg/m2) (median, range) | 25.1 (17.0–42.6) |
| GT | |
| 1 | 17 (25) |
| 2 | 7 (10) |
| 3 | 42 (61) |
| 4–6 | 3 (4) |
| Treatment-naïve | 33 (48) |
| IFN or SOF-based treatment experience | 23 (33) |
| DAA-based treatment experience | 13 (19) |
| Country (≥ 5% of patient population) | |
| USA | 21 (30) |
| China | 13 (19) |
| New Zealand | 8 (12) |
| Australia | 7 (10) |
| Japan | 6 (9) |
| Fibrosis score | |
| F0–F1 | 33 (49) |
| F2 | 9 (13) |
| F3 | 11 (16) |
| F4 | 14 (21) |
| Baseline HCV RNA level (IU/ml) (mean, SD) | 9,585,957 ± 8,247,669 |
| Baseline HCV RNA level (IU/ml) (median, range) | 8,140,000 (135,000–36,100,000) |
| < 1,000,000 | 5 (7) |
| ≥ 1,000,000— < 2,000,000 | 7 (10) |
| ≥ 2,000,000 | 57 (83) |
| HCV RNA level (IU/ml) (median, range) | |
| On-treatment virologic failurea | 7,425,000 (61,200–28,500,000) |
| Relapse by PTW12b | 2,130,000 (7,040–27,900,000) |
| Relapse by PTW4c | 1,780,000 (72,400–20,300,000) |
| Relapse between PTW4 and PTW12d | 3,990,000 (7040–27,900,000) |
| All virologic failure subjects | 3,350,000 (7040–28,500,000) |
| Baseline HCV RNA level (log10 IU/ml) (mean, SD) | 6.8 ± 0.5 |
| Baseline HCV RNA level (log10 IU/ml) (median, range) | 6.9 (5.1–7.6) |
| HCV RNA level (log10 IU/ml) (median, range) | |
| On-treatment virologic failurea | 6.9 (4.8–7.5) |
| Relapse by PTW12b | 6.3 (3.8–7.4) |
| Relapse by PTW4c | 6.3 (4.9–7.3) |
| Relapse between PTW4 and PTW12d | 6.6 (3.8–7.4) |
| All virologic failure subjects | 6.5 (3.8–7.5) |
| HIV co-infectione | 1 (2) |
| Recent injection drug usef | 1 (1) |
Patients were excluded from clinical trials if they had comorbid HBV or decompensated cirrhosis
BMI body mass index, DAA direct-acting antiviral, GT genotype, HBV hepatitis B virus, HIV human immunodeficiency virus, IFN interferon, PTW post-treatment week, SD standard deviation, SOF sofosbuvir
aN = 20
bN = 49
cN = 36
dN = 13
eTwenty-one patients had missing HIV data
fWithin the last 12 months