BlackBoxRX
 
We highly recommend enabling Javascript while using the BlackBoxRX site.

Elbasvir/Grazoprevir

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

  • Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ZEPATIER. 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

FDA and Industry Communications

Index to FDA Safety Information

Patient Counseling Information

Package Inserts

Elbasvir/Grazoprevir

Additional Information

PubMed - ZEPATIER

Updated May 2017