Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login


Medication safety

EMA extends review of antivirals for hepatitis C

The European Medicines Agency (EMA) is extending its review of direct-acting antiviral (DAA) treatments for hepatitis C to look at evidence that shows they are associated with liver cancer recurrence.

In March 2016, the agency launched a review into reports of hepatitis B reactivation in patients who had been infected with both hepatitis B and C viruses and who were being treated with DAAs for hepatitis C.

But research published in April 2016[1] unexpectedly showed that treatment with DAAs in patients with a history of hepatocellular carcinoma was associated with a high rate of cancer recurrence.

The EMA has therefore increased the scope of the original review to include the risk of liver cancer with medicines including daclatasvir, dasabuvir and sofosbuvir.

In the study, published in the Journal of Hepatology (online, 12 April 2016), 16 (28%) of 58 patients developed tumour recurrence after a median follow-up of 5.7 months after starting DAA treatment. All patients had previously achieved a complete response following treatment for their tumour and most were considered at low-to-moderate risk of recurrence. The authors noted that this recurrence rate was much higher than the known incidence among patients successfully treated for hepatocellular carcinoma.

The EMA’s Pharmacovigilance Risk Assessment Committee will produce a set of recommendations to be forwarded to the Committee for Medicinal Products for Human Use to adopt an opinion on the drugs.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201037

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Liver cancer

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.