EMA broadens scope of safety review for Hep C antivirals
- The European Medicines Agency (EMA) expanded a safety review of hepatitis C antivirals to examine the risk of liver cancer returning in patients who took the drugs. The review was originally aimed to assess the risk of hepatitis B reemergence.
- A new study this year suggested patients could be at higher risk of hepatocellular carcinoma returning earlier than hepatitis C patients who had not been treated with the direct-acting antivirals.
- The review will include many of the best-selling hep C treatments, such as Gilead's Harvoni and Sovaldi, Bristol-Myers Squibb's Daklinza, and AbbVie's Viekirax.
As researchers continue to collect long-term data on the oral hepatitis C treatments that have revolutionized treatment, a deeper understanding of their safety profile has begun to emerge.
Last December, the FDA issued a warning about AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir) and made AbbVie update its label to reflect increased risk of liver injury, hepatic decompensation and liver failure in patients with cirrhosis (which is 15% to 30% of all hepatitis C patients).
The EMA first began its review on March 17, following reports of hepatitis B re-activation in patients with both hepatitis B and C who had been treated with the antivirals. Now, it will also assess the risk of hepatocellular carcinoma in addition to hepatitis B. The agency aims to determine whether regulatory action on the drugs' marketing authorizations is needed.
After the Pharmacovigilance Risk Assessment Committee (PRAC) completes its review, its recommendations will eventually be considered by the European Commission for EU adoption.