Safety advisory – risk of hepatitis B virus reactivation

19 December 2016

Consumers and Healthcare Professionals are advised that direct-acting antiviral (DAA) medicines for the treatment of chronic hepatitis C virus (HCV) infection have been associated with reactivation of hepatitis B virus (HBV) in patients with a current or previous HBV infection.

A recent TGA review of the available data, including data from international regulators, medical literature and the post-market setting, found evidence of an association between treatment of chronic HCV with DAA medicines and reactivation of HBV in a small number of patients with current or previous HBV infection.

Reactivation of HBV can cause serious liver problems, including hepatitis, liver failure and in rare cases death.

The TGA is working with sponsors of DAA medicines to update their Product Information to contain warnings about HBV reactivation, including the need for HBV screening prior to DAA therapy, monitoring of patients with positive HBV serology and HBV treatment according to clinical guidelines.

DAA medicines available in Australia include:

  • daclatasvir (Daklinza)
  • asunaprevir (Sunvepra)
  • ombitasvir/paritaprevir/ ritonavir/dasabuvir (Viekira Pak)
  • ombitasvir/paritaprevir/ ritonavir/dasabuvir/ ribavirin (Viekira Pak-RBV)
  • elbasvir/grazoprevir (Zepatier)
  • ledipasvir/sofosbuvir (Harvoni)
  • sofosbuvir (Sovaldi)
  • simeprevir (Olysio/Janssen Simeprevir)*

* sponsor has advised that simeprevir was discontinued on 31 October 2016, but will remain on the Australian Register of Therapeutic Goods until February 2017