NEW YORK -- December 4, 2008 -- The European Commission has approved peginterferon alfa-2a (Pegasys) plus ribavirin (Copegus) for the retreatment of hepatitis C in patients who were not successfully treated with an initial course of interferon alfa (pegylated or nonpegylated), either alone or in combination with ribavirin.
The approval is based on results from the REPEAT study, which investigated the retreatment with peginterferon alfa-2a of patients not responding to prior peginterferon alfa-2b (12-kDa)/ribavirin combination therapy. The study demonstrated that in patients who were prior nonresponders to peginterferon alfa-2b (PegIntron) plus ribavirin, 72 weeks of retreatment with peginterferon alfa-2a plus ribavirin doubled the chances of achieving a sustained virological response (SVR) compared with 48 weeks.
Furthermore, the study showed that 57% of patients who responded by week 12 went on to achieve SVR with 72 total weeks of retreatment.
"The high predictability of response at week 12 with [peginterferon alfa-2a] plus [ribavirin] should be an important factor when considering whether to retreat hepatitis C," said Patrick Marcellin, University of Paris, Paris, France, and Viral Hepatitis Research Unit, Hôpital Beaujon, Clichy, France. "It means that physicians and patients will be able to determine -- after only 3 months -- whether treatment is likely to result in a cure."
The safety profile for peginterferon alfa-2a plus ribavirin in prior nonresponders was similar to that seen in patients receiving treatment for the first time.
The recommended length of peginterferon alfa-2a treatment for patients is based on their virus genotype and type of prior treatment. For patients with genotype 1 virus who did not respond to initial treatment with pegylated interferon and ribavirin, it is recommended that they be retreated with peginterferon alfa-2a for an extended period of 72 weeks.
For all other treatment-experienced patients, the recommended treatment period is 48 weeks. The label recommends measuring a patient's virus levels after 12 weeks of treatment to determine whether a full course of treatment is likely to result in a cure.
SOURCE: Roche
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