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Roche’s Pegasys Fails to Curb Hepatitis C Progression in Study

By Dermot Doherty

Dec. 3 (Bloomberg) -- Roche Holding AG’s Pegasys drug for hepatitis C didn’t keep liver disease at bay when given in smaller doses over a longer period of time, a study found.

The medicine failed to slow disease progression in patients who hadn’t responded to initial treatment, according to the study in the New England Journal of Medicine. The research, which focused on 1,050 patients with advanced hepatitis on so-called maintenance therapy, also found the patients’ health declined over a four-year period.

Pegasys won approval as a treatment for hepatitis C in 2001 and last year generated 1.6 billion Swiss francs ($1.3 billion) in sales for Basel, Switzerland-based Roche. Hepatitis C, the main cause of liver cancer, is a blood-borne infection that affects as many as 200 million people worldwide. Patients on Pegasys are typically given 16 to 48 weeks of therapy. Hepatitis C causes no symptoms in 80 percent of cases and is responsible for about two-thirds of all liver transplants.

“This course of treatment had been adopted by a number of doctors in the U.S. and in other countries, though it had yet to be proven to work. That practice should be stopped based on the results of this trial,” researcher Adrian Di Bisceglie, a professor of internal medicine and co-director of the Liver Center at Saint Louis University, said in a statement.

Half of the patients in the study were given 90 micrograms of Pegasys, also known as peginterferon, a week for 3 1/2 years. The rest made up a control group. About 30 percent of the patients in both groups went on to develop liver failure or cancer, or else died. About 10 percent to 12 percent of patients with milder cirrhosis developed severe liver disease, the study found.

The U.S. National Institutes of Health funded the research.

To contact the reporter on this story: Dermot Doherty in Geneva at [e-mail]