EMA to Review New Hep C Drugs for Possible Hep B Reactivation

Megan Brooks


March 18, 2016

The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.

They are daclatasvir (Daklinza, Bristol-Myers Squibb), dasabuvir (Exviera, AbbVie), the combination of sofosbuvir and ledipasvir (Harvoni, Gilead Sciences), simeprevir (Olysio, Janssen), sofosbuvir (Sovaldi, Gilead Sciences), and the ombitasvir/paritaprevir/ritonavir combination (Viekirax, AbbVie).

"The review follows cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C," the EMA said in a statement.

The EMA will assess the extent of hepatitis B reactivation in patients treated with direct-acting antivirals for hepatitis C and evaluate whether any measures are needed to optimize the treatment.

The review is being carried out by the EMA Pharmacovigilance Risk Assessment Committee.

After conclusion of the committee's review, it will make a set of recommendations, which will be forwarded to the Committee for Medicinal Products for Human Use, the committee responsible for questions concerning medicines for human use, which will adopt a final opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all European Union member states.

While the review is ongoing, patients receiving one of the direct-acting antivirals who have questions or concerns should speak to their physicians, the EMA advises.


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