Hoffmann-La Roche Limited today announced that the U.S. Food and Drug Administration (FDA) has approved PEGASYS(R) (peginterferon alfa-2a) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alfa.
Patients in whom efficacy was demonstrated include those who are most difficult-to-treat – patients with compensated cirrhosis (liver scarring) and those patients who are genotype 1. The approval was based on the results of three pivotal Phase III clinical trials that demonstrated PEGASYS’ superior efficacy over conventional interferon, with sustained virological responses as high as 38 per cent versus 19 per cent in patients with chronic hepatitis C. PEGASYS is the only pegylated interferon indicated in the United States for treatment in patients with advanced liver disease i.e. compensated cirrhosis.
In those patients who have a more treatment-resistant disease, PEGASYS monotherapy achieves a sustained virological response (SVR) close to four times higher (30 per cent) than conventional interferon therapy (8 per cent)(i). Higher SVR results were also found in patients with genotype 1, the most common genotype in the U.S. and Canada and the most difficult to treat. A SVR indicates that there is no detectable virus in the blood six months after completion of therapy.
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