BASEL, Switzerland -- June 26, 2008 -- The European Commission has approved a shortened, 16-week course of treatment with peginterferon alfa-2a (40 KD) (Pegasys) plus ribavirin (Copegus) for certain hepatitis C patients. The 4-month treatment course will be for patients with particular strains of chronic hepatitis C who have low virus levels before starting treatment, and who show a rapid virological response by clearing the virus from the blood within the first 4 weeks of treatment. This shorter treatment duration with peginterferon alfa-2a/ribavirin will provide patients with the full benefits of therapy while reducing unnecessary drug exposure. This is good news for eligible patients as previously, all patients with genotype 2 or 3 hepatitis C virus (HCV) received 24 weeks of peginterferon alfa-2a/ribavirin therapy, regardless of their baseline virus levels and response while on treatment.

The approval of this treatment regimen is based on data from several studies that show shorter treatment duration in patients who have a rapid response to peginterferon alfa-2a/ribavirin results in high cure rates, similar to those achieved with the currently approved 24 weeks of therapy. An analysis of a major study that evaluated the efficacy and safety of 16 weeks versus 24 weeks of treatment with peginterferon alfa-2a/ribavirin in patients with genotype 2 or 3 HCV, showed that a similar number of patients achieved a cure. In patients with low virus levels before treatment and a rapid virological response, the cure rates for 16 and 24 weeks of treatment were essentially identical.

"This EU approval is important, as it means that we can tailor a patient's treatment with [peginterferon alfa-2a] based on an early marker of response without a loss in the regimen's effectiveness" said Stefan Zeuzem, MD, Johann-Wolfgang Goethe University Hospital, Frankfurt, Germany. "This is good news for doctors, who now have the reassurance of offering a shorter treatment regimen, and for patients themselves, who will have the possibility to be cured with only 16 weeks of treatment."

SOURCE: Roche Pharmaceuticals

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