FDA warns antiviral Hepatitis C drug users risk reactivation

By Ryan Maass

WASHINGTON, Oct. 5 (UPI) -- Patients using antiviral drugs to treat hepatitis C risk developing liver problems or even death, the U.S. Food and Drug Administration said in a warning.

According to FDA officials, patients using direct-acting antiviral medicines for hepatitis C may end up reactivating the disease in the form of hepatitis B. The agency notes patients who experienced reactivation did so after a period of 4 to 8 weeks.


The FDA is requiring drug makers to attach a Boxed Warning to their labels. Medical professionals are recommended to screen all patients for evidence of hepatitis B before starting treatment with direct-acting antiviral medicines, the agency said in its latest official warning.

Hepatitis is characterized by an inflammation of the liver typically as a result of heavy alcohol use, bacterial or viral infections, or other diseases.

Hepatitis C begins as a viral infection, and is spread through contact with the blood of an infected person. The illness has the potential to last a lifetime. Direct-acting antiviral medicines, also referred to as DAAs, are designed to reduce the amount of hepatitis viruses in the body by preventing them from multiplying.


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