Safety warning: DAAs linked to hepatitis B risk


The hep C medicines have been associated with reactivation of the hep B virus, which can lead to liver failure and even death

A TGA review has 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.

The review looked at available data from international regulators, medical literature and the post-market setting.

HBV reactivation is diagnosed when there is an abrupt, marked increase in serum HBV DNA level, and may be accompanied by hepatitis ranging from mild to severe.

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

“Patients should be screened for evidence of current or past HBV infection before initiating treatment with a DAA medicine,” it recommends.

Patients should also be aware that they should seek urgent medical advice if:

  1. They are currently receiving treatment for an HCV infection with a DAA medicine; and,
  2. Notice any new symptoms of liver disease, including loss of appetite, tiredness, nausea, vomiting, stomach pain, yellowing of the skin or eyes, or confusion.

DAA medicines currently 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

The TGA says it 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.

See the full safety advisory here.

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