The Therapeutic Goods Administration (TGA) has warned 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 people with a current or previous HBV infection.
The TGA said following a recent review of available data,including data from international regulators, medical literature and the post-market setting, it 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 TGA statement noted that "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) - discontinued in October but remains on TGA register till next February.
If you are receiving hepatitis C DAAs and have a history of hepatitis B infection, speak to your doctor who may order a blood test to confirm your status.
If you notice symptoms of liver disease such as loss of appetite, tiredness, nausea, vomiting, stomach pain, yellowing of the skin or eyes or confusion, seek medical advice immediately.
Health professionals are advised to test people for hepatitis B before starting them on hepatitis C treatment DAAs. For people with no evidence of past or current hepatitis B and no immunity, vaccination should be considered.
