Schering Plough gets label change for hepatitis C drug

Schering-Plough’s hepatitis C drug, Intron A, has had its EU label changed on the back of results from a five-year follow-up study on the drug’s long-term effectiveness.

Drug trials on 1,071 patients infected with the hepatitis C virus revealed that there was a sustained loss of serum containing virus RNA, six months after the completion of the treatment. Serum loss is often an indicator to the long-term clearance of the virus, or clinical “cure”, as Schering-Plough describes it. This sustained virus response (SVR) was observed in 492 of the patients using the interferon-based drug and of those, only 12 relapsed.

The study’s lead investigator, John McHutchison, MD, of Duke University, said: “This large study involving more than 1,000 hepatitis C patients demonstrates that, even with close follow-up over a five-year period, patients who have achieved an SVR have essentially no evidence of clinical or virological disease.”

“Recognition of this durability of response underscores the efficacy of interferon-based antiviral therapy,” he added.

According to the Hepatitis C Trust, a recently-formed national UK charity, hepatitis C was only discovered in the 1980s when it was clear that something other than hepatitis A and B was causing liver disease. It is an RNA virus, meaning it mutates quickly and it is transmitted through infected blood. The trust says approximately 200 million people are infected around the world and adds that a vaccine is not likely soon.

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