The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health (England) and regulates medicines, medical devices and blood components for transfusion in the UK. In the January addition of their Drug Safety Update the agency changed their advice on the use of Direct Acting Antiviral therapies for the treatment of Hepatitis C.
All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens. Patients who are co-infected with hepatitis B and C viruses are at risk of hepatitis B reactivation, and should be monitored and managed according to current clinical guidelines.
This changed advice reflects a concern that the successful treatment of hepatitis C with the new direct acting antiviral products could allow a previously supressed hepatitis B infection to reactivate.
Both hepatitis C and hepatitis B are blood borne viruses and can be transmitted in very similar ways. As a result we are concerned that people with bleeding disorders who were infected with hepatitis C might also have been infected with Hepatitis B at the same time. As with hepatitis C, hepatitis B can also be transmitted sexually so we are conscious this change in advice could be relevant to some partners too. With so many people recently completing the treatment using direct acting antivirals we are taking the new advice from the MHRA very seriously.
We raised these concerns at the recent meeting of the Steering Group of the Scottish Inherited Bleeding Disorders Network. We were assured that Scottish Haemophilia Centres have not seen an increase in hepatitis B cases or in unusual liver function test results.
However, in response to our concerns, all Scottish Haemophilia Centres have been asked to contact their local hepatology teams and discuss this issue. They will ascertain that appropriate hepatitis B reactivation screening in patients receiving these antiviral regimens is being undertaken. Anyone who is anxious about potential hepatitis B reactivation, and has recently completed treatment with direct acting antivirals, can also request a test from their Haemophilia Centre. The Network has asked to receive reports of any cases of Hepatitis B reactivation which are discovered so that the situation can be monitored.