EMA to review safety of direct-acting antivirals after reports of hepatitis B reactivation


The European Medicines Agency (EMA) is to review the safety of direct-acting antivirals used to treat patients with chronic hepatitis C infection.

The decision follows reports of cases of hepatitis B being reactivated in patients infected with both the hepatitis B and C viruses who were being treated with the antivirals. The patients had been prescribed the antivirals to treat their hepatitis C.

The products at the centre of the review are: daclatasvir (Daklinza); dasabuvir (Exviera); sofosbuvir/ledipasvir (Harvoni); simeprevir (Olysio); sofosbuvir (Sovaldi); and ombitasvir/paritaprevir/ritonavir (Viekirax). They can be used by patients without the need for treatment with interferons, which are generally less well tolerated.

The direct-acting antivirals work by blocking the action of proteins in the hepatitis C virus that are essential for it to replicate.

The review, which was announced after the latest EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting on 14–17 March 2016, will be carried out by PRAC and follows a request by the European Commission (EC). The recommendations will then be forwarded to the EMA’s Committee for Medicinal Products for Human Use but will need final approval by the EC.

Patients are advised to speak to their pharmacist or doctor if they have any concerns about the antivirals pending the outcome of the review, the EMA says.

Last updated
The Pharmaceutical Journal, EMA to review safety of direct-acting antivirals after reports of hepatitis B reactivation;Online:DOI:10.1211/PJ.2016.20200903

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