Europe Approves Hepatitis C Re-Treatment Protocol
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Roche wins European approval for hepatitis drug
5th December 2008
By Staff Writer
Roche has announced that the European Commission has approved Pegasys plus Copegus for the re-treatment of hepatitis C patients who were not successfully treated with an initial course of interferon alpha, either alone or in combination with ribavirin.
The European approval provides a significantly broader indication for peginterferon alfa-2a and establishes a new standard of care for treatment-experienced patients with the most difficult-to-treat virus, the company said.
A large, Roche-sponsored study called REPEAT demonstrated that 72 weeks of re-treatment with peginterferon alfa-2a plus ribavirin doubled the chance of achieving a cure, compared to 48 weeks, in patients who were prior non-responders to PegIntron (peginterferon alfa-2b) and ribavirin. Furthermore, the study showed that 57% of patients who responded by week 12 (defined as HCV RNA levels of less than 50 IU/mL) went on to achieve a cure with 72 total weeks of re-treatment.
William Burns, CEO of Roche’s pharmaceuticals division, said: “This new indication for Pegasys plus Copegus is another demonstration of Roche’s commitment to extend the promise of a cure to as many chronic hepatitis C patients as possible.
“Our approach is to optimize and individualize treatment to increase patients’ chance of success with Pegasys and Copegus, while establishing them as the backbone for combination with novel agents in development, both by Roche and through external partnerships and collaborations.”
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