The European Medicines Agency (EMA) is reviewing six hepatitis C direct acting anti-virals (DAA) for possible hepatitis B re-activation in people with co-infection receiving hepatitis C treatment.

The EMA review follows cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated withDAAs for hepatitis C.

Hepatitis B re-activation refers to a return of active infection in a patient whose hepatitis B infection had been inactive.

The treatments being reviewed are daclatasvir (Daklinza), ledipasvir/sofosbuvir (Harvoni), sofosbuvir (Sovaldi), simeprevir (Olysio), dasaprevir (Exviera) and ombitasvir/paritaprevir (Viekirax). Daclatasvir, ledipasvir/sofosbuvir, and sofosbuvir were among the treatments recently listed on the Phamaceutical Benefits Scheme (PBS).

The EMA will assess the extent of the hepatitis B re-activation in people being treated with these DAAs and whether measures are needed to optimise treatment for people with hepatitis B and C co-infection.

If you are are receiving DAA treatment for hepatitis C and have questions or concerns about the issues raised here, you should speak to your specialist.