05.05.2017 - Conclusion of the procedure

Direct-acting antiviral agents for the treatment of hepatitis C: EMA confirms recommendation for hepatitis B screening
Further studies are needed to assess the risk of liver cancer associated with these drugs

15.04.2016 - Expansion of the procedure

In addition, data from a study on the recurrence of liver cancer (hepatocellular carcinoma) in patients treated with direct antiviral drugs for hepatitis C became available in April 2016. The study suggests that treated patients are at risk for earlier recurrence of cancer than patients with hepatitis C who were not treated with direct-acting antiviral drugs.

18.03.2016 - Procedure started

The BfArM issues information on the initiation of a European safety review regarding direct-acting antiviral medicinal products for treatment of chronic hepatitis C (HCV), an infectious disease that affects the liver.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

To the risk assessment procedure (available in German only)