The European Medicines Agency on Friday, warned that drugs which are highly effective against hepatitis C, may trigger latent hepatitis B in patients infected with both types of hepatitis.
The medicines agency in a statement, named the antivirals Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax used to treat chronic hepatitis C, an infectious liver disease.
“Cases of the return of previously inactive hepatitis B infection, which can be fatal, have been reported in patients treated,” with this class of drug, the agency said in a statement announcing the findings of a probe.
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.