Table 5. Safety summary.
| Variable, n (%) | All patient (N = 273) | No cirrhosis (n = 138) | Child-Pugh A cirrhosis (n = 109) | Child-Pugh B/C cirrhosis (n = 26) |
|---|---|---|---|---|
| Serious adverse event | 12 (4.4) | 1 (0.7) | 5 (4.6) | 6 (23.1) |
| Pneumonia | 1 (0.4) | 0 (0) | 0 (0) | 1 (3.8) |
| Spontaneous bacterial peritonitis | 3 (1.1) | 0 (0) | 0 (0) | 3 (11.5) |
| Variceal bleeding | 2 (0.7) | 0 (0) | 1 (0.9) | 1 (3.8) |
| Hepatocellular carcinoma | 4 (1.5) | 0 (0) | 3 (2.8) | 1 (3.8) |
| Herpes zoster | 1 (0.4) | 0 (0) | 1 (0.9) | 0 (0) |
| Duodenal ulcer bleeding | 1 (0.4) | 1 (0.7) | 0 (0) | 0 (0) |
| Discontinuation due to adverse event* | 1 (0.4) | 0 (0) | 0 (0) | 1 (3.8) |
| Death* | 1 (0.4) | 0 (0) | 0 (0) | 1 (3.8) |
| Adverse event in ≥ 10% of patients | ||||
| Fatigue | 74 (27.1) | 30 (21.7) | 32 (29.4) | 12 (46.2) |
| Headache | 56 (20.5) | 28 (20.3) | 22 (20.2) | 6 (23.1) |
| Nausea | 49 (17.9) | 22 (15.9) | 21 (19.3) | 6 (23.1) |
| Insomnia | 38 (13.9) | 18 (13.0) | 15 (13.8) | 5 (19.2) |
| Laboratory adverse event | ||||
| Hemoglobin | ||||
| 8.0–10.0 g/dL | 21 (7.7) | 1 (0.7) | 14 (12.8) | 6 (23.1) |
| < 8.0 g/dL | 4 (1.5) | 0 (0) | 3 (2.8) | 1 (3.8) |
| White blood cell count | ||||
| 2.0–3.0 x 109 cells/L | 7 (2.6) | 0 (0) | 5 (4.6) | 2 (7.7) |
| < 2.0 x 109 cells/L | 2 (0.7) | 0 (0) | 1 (0.9) | 1 (3.8) |
| Platelet count | ||||
| 50–75 x 109 cells/L | 46 (16.8) | 3 (2.2) | 24 (22.0) | 19 (73.1) |
| < 50 x 109 cells/L | 10 (3.7) | 0 (0) | 4 (3.7) | 6 (19.2) |
| Total bilirubin | ||||
| 1.5–3.0 x ULN | 21 (7.7) | 2 (1.4) | 11 (10.1) | 8 (30.8) |
| > 3.0 x ULN | 9 (3.3) | 0 (0) | 4 (3.7) | 5 (19.2) |
| ALT | ||||
| 3–5 x ULN | 6 (2.2) | 3 (2.2) | 2 (1.8) | 1 (3.8) |
| > 5x ULN | 2 (0.7) | 1 (0.7) | 1 (0.9) | 0 (0) |
| eGFR | ||||
| 15–30 mL/min/1.73m2 | 3 (1.1) | 0 (0) | 2 (1.8) | 1 (3.8) |
| < 15 mL/min/1.73m2 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
* One patient expired due to pneumonia at treatment week 3, which was considered not related to DAA treatment.