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news.The FDA has approved Roche's Pegasys, the most prescribed hepatitis C medication in the US, for the treatment of chronic hepatitis B, making it the first and only pegylated interferon in this indication.
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Pegasys (peginterferon alfa-2a) is now approved for both variations of the chronic hepatitis B virus – HBeAg-positive and HBeAg-negative.
Pegasys was approved in 2002 by the FDA for use alone and in combination with Roche’s Copegus (ribavirin, USP) for the treatment of adults with chronic hepatitis C. In February 2005, Pegasys became the first and only FDA-approved therapy alone and in combination with Copegus for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV whose HIV is clinically stable.
In two large-scale multinational phase III trials, in more than 1,500 patients with both the HBeAg-positive and HBeAg-negative variations of chronic hepatitis B, more patients achieved a sustained response with Pegasys than with lamivudine (GlaxoSmithKline’s Epivir) 24 weeks after a defined 48 week period of therapy. These studies demonstrated that the addition of lamivudine to Pegasys did not improve response rates over Pegasys alone.