Table 4.
Safety and adverse events (AEs) during the 3‐month treatment period
| Events | AHC | CHC | Total | |||
|---|---|---|---|---|---|---|
| n = 68 | % | n = 11 | % | n = 79 | % | |
| Any AEs (person) | 48 | 70.59 | 7 | 63.64 | 55 | 69.62 |
| Any AEs (person × time) | 98 | 13 | 111 | |||
| Any AEs (person × time, including SAEs) | 100 | 13 | 113 | |||
| Itching | 10 | 14.71 | 1 | 9.09 | 11 | 13.92 |
| Fatigue | 19 | 27.94 | 2 | 18.18 | 21 | 26.58 |
| Headache | 13 | 19.12 | 2 | 18.18 | 15 | 18.99 |
| Nausea | 12 | 17.65 | 3 | 27.27 | 15 | 18.99 |
| Vomiting | 8 | 11.76 | 1 | 9.09 | 9 | 11.39 |
| Insomnia | 11 | 16.18 | 1 | 9.09 | 12 | 15.19 |
| Dizziness | 4 | 5.88 | 0 | 0.00 | 4 | 5.06 |
| Diarrhea | 5 | 7.35 | 1 | 9.09 | 6 | 7.59 |
| Drug‐related AEs (person) | 26 | 38.24 | 3 | 27.27 | 29 | 36.71 |
| Drug‐related AEs (person × time) | 45 | 66.18 | 5 | 45.45 | 50 | 63.29 |
| SAEs | 2 | 0 | 2 | |||
| Drug‐related SAEs | 0 | 0 | 0 | |||
| Discontinuation due to an AE | 2 | 0 | 2 | |||
| 0 | 0 | |||||
Abbreviations: AHC, acute hepatitis C; CHC, chronic hepatitis C; SAE, severe adverse event.