Table 3.
Adverse events and laboratory abnormalities during the treatment period
| Sofosbuvir, ledipasvir, and asunaprevir (n=6) |
Sofosbuvir, daclatasvir, and simeprevir (n=6) |
Sofosbuvir, daclatasvir, and asunaprevir (n=6) |
|
|---|---|---|---|
| Common adverse events | |||
| Fatigue | 1 (17%) | 1 (17%) | 2 (33%) |
| Nausea | 1 (17%) | 0 | 0 |
| Headache | 1 (17%) | 1 (17%) | 1 (17%) |
| Dizziness | 0 | 1 (17%) | 0 |
| Insomnia | 1 (17%) | 0 | 1 (17%) |
| Abdominal pain | 0 | 1 (17%) | 1 (17%) |
| Constipation | 1 (17%) | 0 | 0 |
| Diarrhoea | 0 | 1 (17%) | 1 (17%) |
| Dermatitis | 0 | 1 (17%) | 1 (17%) |
| Common cold | 1 (17%) | 0 | 1 (17%) |
| Laboratory abnormalities | |||
| Any grade 3 laboratory abnormality during treatment |
1 (17%) | 1 (17%) | 0 |
| Decreased haemoglobin | 0 | 1 (17%) | 0 |
| Raised total bilirubin | 1 (17%) | 0 | 0 |
There were no deaths or discontinuations due to adverse events. All adverse events and serious adverse events were recorded from the time the consent form was signed until 14 days after cessation of treatment. The relatedness (probable or possible) of the adverse event to the regimen was determined by the investigator; patients could have had more than one adverse event.