Precautions of Epclusa

1. Risk of HBV Reactivation:Before treatment, markers of HBV infection must be tested. During treatment and follow-up after treatment, it is necessary to monitor HBV reactivation and hepatitis recurrence in patients with HCV/HBV coinfection, and initiate HBV management based on clinical indications.

2. Severe Symptomatic Bradycardia Caused by Concomitant Use with Amiodarone:When amiodarone is used in combination with sofosbuvir-containing regimens, there have been reports of symptomatic bradycardia and cases requiring pacemaker intervention, including even one case of death due to cardiac arrest. Concomitant use of Epclusa (Sofosbuvir/Velpatasvir) with amiodarone is not recommended. If concomitant use is unavoidable and no other feasible options are available, cardiac monitoring is required, and patients should be informed of the risk of bradycardia.

3. Risk of Reduced Efficacy Caused by Concomitant Use with P-gp Inducers and/or Moderate-to-Strong CYP Inducers:Drugs such as rifampicin, St. John's wort, and carbamazepine may significantly reduce the plasma concentrations of sofosbuvir and/or velpatasvir, leading to decreased efficacy of Epclusa. Concomitant use of these drugs with Epclusa is not recommended.

4. Risks Associated with Combination Therapy with Ribavirin:If Epclusa is used in combination with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen.

FDA，2022.04