EU extends safety review of chronic hep C treatments

Last Updated: 2016-04-15

By Reuters Staff

(Reuters) - The European health regulator said it extended a safety review of chronic hepatitis C treatments after new data showed patients taking the drugs were at risk of their liver cancer returning.

"The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals," the European Medicines Agency (EMA) said.

The review covers some of the top-selling products in the multi-billion dollar hepatitis C market. These drugs cure well over 90 percent of patients with the liver disease and cut down the treatment duration.

Direct-acting antivirals work by blocking proteins in the hepatitis C virus that help it replicate.

The EMA cited Bristol-Myers Squibb Co's Daklinza (daclatasvir), AbbVie Inc's Exviera (dasabuvir) and Viekirax (ombitasvir/paritaprevir/ritonavir), Gilead Sciences Inc's Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) and Johnson & Johnson's Olysio (simeprevir) in its statement.

The safety review extension follows the release of new data this month from a study.

The EMA started its review last month after the hepatitis B virus re-activated in patients who were infected both by hepatitis B and C viruses, and were being treated with the hepatitis C drugs.

The European Commission will take into consideration recommendations from the EMA, and adopt a legally binding decision that covers all EU member states.