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EMA investigating rare adverse events associated with hepatitis C treatment

The European Medicines Agency (EMA) has started a review of medicines known as direct-acting antivirals used for treating chronic hepatitis C infection.

There have been anecdotal reports of hepatitis B re-activation in some patients who have been infected with both hepatitis B and C viruses and who were treated with direct-acting antivirals for hepatitis C. Hepatitis B re-activation is the return of active infection in a patient whose hepatitis B infection had been chronic.

In April 2016, a study was published regarding the risk of liver cancer (hepatocellular carcinoma) returning in patients who were treated with these direct-acting antivirals for hepatitis C. The study suggests that some patients were at risk of their cancer coming back earlier than in those patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the EMA review has now been extended to also assess the risk of liver cancer with these medicines. The review will take place over May and June of this year.

The EMA states that, “While the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.”

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