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Sofosbuvir

Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV

  • Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Sofosbuvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. [see WARNINGS AND PRECAUTIONS (5.1)].

FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information

Package Inserts

Sofosbuvir
Ledipasvir/Sofosbuvir
Sofosbuvir/Velpatasvir
Sofosbuvir/Velpatasvir/Voxilaprevir

Additional Information

PubMed - EPCLUSA
PubMed - HARVONI
PubMed - SOVALDI

Updated August 2020