Direct-acting antivirals used for treating Hepatitis C: possible hepatitis B re-activation
2017.05.05
Active substance: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir
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)