Table 1.
Adverse effects with sofosbuvir/velpatasvir combination from ASTRAL 1, 2, 3 trials
| Adverse effect | Recommendation |
|---|---|
| Headache | Seen in 22% of patients; usually mild and tolerable. |
| Fatigue | Seen in 15% of patients; mild. |
| Nausea | Seen in 9% of patients; mild. |
| Asthenia | Seen in 5% of patients. |
| Insomnia | Seen in 5% of patients; usually mild. |
| Bradycardia | Avoid concomitant administration with amiodarone. |
| Anemia | Seen in 26% of patients when given with ribavirin in decompensated cirrhotics. Monitor hemoglobin. If hemoglobin is below 8 g/dL, titrate dose of ribavirin or stop it completely. |
| Rash | Seen in 2% of patients and of mild to moderate severity. |
| Depression | Seen in 1% of patient population and of mild severity. |
| Lipase levels | Asymptomatic lipase elevations (up to 3× ULN) may be seen with combination therapy; monitor. |
| Indirect bilirubin | Asymptomatic increase up to 3 mg/dL may be seen with coadministration with antiretroviral drugs for HIV/HCV coinfected patients. |