There have been only about 30 cases of hepatitis B reactivation out of thousands of patients taking the drugs, the agency said. And there was not enough information to draw a conclusion on cancer risk. But a special risk assessment committee of the agency recommended that all patients be screened for hepatitis B virus before starting any of these treatments.
It also proposed that a warning be included in the drug information leaflet. The drugs, a new class known as “direct-acting antivirals” are more effective than their predecessors. At a cost of some €40,000 to €80,000 ($43,000-$86,000) for a 12-week course, they are the preserve of a lucky few.
Hepatitis is an inflammation of the liver, most often caused by a virus but sometimes by drug or alcohol abuse, other infections, or autoimmune diseases. The B and C types usually occur from contact with body fluids of an infected person. Other than for hepatitis B, there is no vaccine against hepatitis C.
Source: Swankpharm