The Food and Drug Administration (FDA) has approved class-wide labeling revisions regarding the risk of hepatitis B virus (HBV) reactivation in patients coinfected with hepatitis C virus (HCV) and HBV being treated with HCV direct-acting antiviral (DAA) agents.

HBV reactivation is described as an abrupt rise in HBV replication manifesting as a rapid increase in serum HBV DNA level. The labeling update affects the following DAA agents:

  • Daklinza (daclatasvir)
  • Epclusa (sofosbuvir/velpatasvir)
  • Harvoni (ledipasvir/sofosbuvir)
  • Olysio (simeprevir)
  • Sovaldi (sofosbuvir)
  • Technivie (ombitasvir/paritaprevir/ritonavir)
  • Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets)
  • Viekira XR (dasabuvir/ombitasvir/paritaprevir/ritonavir)
  • Zepatier (elbasvir/grazoprevir)

Some cases of HBV reactivation have led to fulminant hepatitis, hepatic failure, and death. There have also been reports in patients receiving certain immunosuppressant or chemotherapeutic agents where the risk of HBV reactivation associated with HCV DAAs may be higher in these patients.

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The addition of a Boxed Warning as well as revisions to the Dosage and Administration, Warnings and Precautions, and Patient Counseling Information sections have been made. The main statements include:

  • Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating treatment with HCV DAAs.
  • In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment and during post-treatment follow-up.
  • Initiate appropriate patient management for HBV infection as clinically indicated.

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