Adverse reactions of Epclusa

1. Adult and pediatric subjects aged 6 years and older: During the 12-week treatment, the most common adverse reactions (incidence ≥10%) were headache and fatigue.

2. Pediatric subjects under 6 years of age: The most common adverse reactions (incidence ≥10%, grade 1 or 2) were vomiting and product use issues (drug regurgitation).

3. Adult patients with decompensated cirrhosis: Among patients receiving Epclusa (Sofosbuvir/Velpatasvir) combined with ribavirin for 12 weeks, the most common adverse reactions (incidence ≥10%) were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

4. Other adverse reactions: These also include rash, depressed mood, and abnormal laboratory findings (such as elevated lipase, elevated creatine kinase, elevated indirect bilirubin, etc.).

5. Post-marketing experience: Severe symptomatic bradycardia has been reported in patients using sofosbuvir-containing regimens in combination with amiodarone; skin rashes (sometimes accompanied by blisters or angioedema-like swelling) have also been reported.

FDA，2022.04