EMA extends review of antivirals for hepatitis C

Liver cancer

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.


[1] Reig M, Mariño Z & Perelló C. Unexpected early tumor recurrence in patients with hepatitis C virus -related hepatocellular carcinoma undergoing interferon-free therapy: a note of caution. Journal of Hepatology 2016. doi:10.1016/j.jhep.2016.04.008

Last updated
The Pharmaceutical Journal, PJ, April 2016, Vol 296, No 7888;296(7888):DOI:10.1211/PJ.2016.20201037

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