What are the precautions for sofosbuvir and velpatasvir (Epclusa)?

Test all patients for evidence of current or previous hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir and velpatasvir (Epclusa) combination. HBV reactivation has occurred in HCV/HBV co-infected patients who were receiving or had completed HCV direct-acting antiviral therapy and who were not receiving HBV antiviral therapy. Some cases result in fulminant hepatitis, liver failure, and death.

1. Risk of hepatitis B virus reactivation in patients co-infected with hepatitis C virus andHBV virus:

HBV reactivation is characterized by a sudden increase in HBV replication, manifested by a rapid increase in serum HBV DNA levels. In patients who have cleared HBV infection, HBsAg may reappear. Reactivation of HBV replication may be accompanied by hepatitis, that is, increased transaminase levels and, in severe cases, increased bilirubin levels, liver failure, and possible death. Monitor for clinical and laboratory signs of hepatitis outbreak or HBV reactivation during treatment HCV with sofosbuvir and velpatasvir combination and during post-treatment follow-up.

2. Severe symptomatic bradycardia occurs when combined with amiodarone (amiodarone):

Post-marketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone was coadministered with sofosbuvir-containing regimens. Bradycardia usually develops within hours to days, but cases have been observed within 2 weeks of starting hepatitis C treatment. Patients taking concomitant beta-blockers, or patients with underlying cardiac comorbidities and/or advanced liver disease, may be at increased risk for symptomatic bradycardia when combined with amiodarone. The bradycardia usually disappears after hepatitis C treatment is stopped.

3. Concurrent use withP-gp inducers and/or moderate and strong CYP inducers may reduce the risk of efficacy:

asDrugs that are P-gp inducers and/or moderate to strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g., rifampicin, St. John's wort, carbamazepine) may significantly reduce the plasma concentrations of sofosbuvir and velpatasvir combinations, resulting in a potential reduction in the therapeutic efficacy of the drugs. Use of these drugs in combination with sofosbuvir and velpatasvir is not recommended.

4. Risks related to ribavirin combination therapy:

If the combination of sofosbuvir and velpatasvir is administered concurrently with ribavirin, the warnings and precautions for ribavirin apply to that combination. For a complete list of warnings and precautions regarding ribavirin, refer the physician to the ribavirin prescribing information.

The original drug of sofosbuvir and velpatasvir has been launched in China and has entered the scope of Class B medical insurance. The domestic trade name is protonsa, and the specification (400mg+100mg)*28 tablets is priced at about 4,000 yuan per box. The original drug of sofosbuvir and velpatasvir has also been launched overseas. There are also generic drugs of sofosbuvir and velpatasvir produced in other countries. The price of the specification (400mg + 100mg) * 28 tablets produced by Everest Pharmaceutical Factory in Bangladesh is about 850 yuan per box (the price may fluctuate due to the exchange rate). The generic drugs produced abroad are basically the same as the original drugs at home and abroad.