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Peginterferon Alfa-2a Gains Chronic Hepatitis B Indication

BASEL, Switzerland, May 16/PRNewswire/ -- Roche announced today that Pegasys, the most prescribed hepatitis C medication in the United States, has been approved by the U.S. Food and Drug Administration for the treatment of chronic hepatitis B (CHB). This makes Pegasys (peginterferon alfa-2a (40 KD)) the first and only pegylated interferon to be approved for the treatment of chronic hepatitis B in the US. Pegasys was approved in the EU for the treatment of chronic hepatitis B in February this year.

The approvals are based on one of the largest clinical development programs in patients with chronic hepatitis B. Importantly, these approvals recognise that a finite course of Pegasys is associated with a lasting and sustained response in patients with chronic compared with a current standard of care, lamivudine.

"Pegasys can now be considered as another option for first-line therapy for patients with chronic hepatitis B, with the aim of achieving a sustained and durable response following a finite course of therapy." said Dr Michael Fried, Professor of Medicine and Director of Hepatology at the University of North Carolina at Chapel Hill and a principal investigator in one of the key Pegasys phase III trials. "The alternative treatments are generally continued for prolonged periods, raising the risk of antiviral resistance."

The Centers for Disease Control in the United States estimates that 1.25 million people in the US are chronically infected with hepatitis B. WHO estimates put the worldwide figure as high as 350 million people. Chronic hepatitis B can lead to cirrhosis, hepatocellular carcinoma and death.

"This approval marks another first for Pegasys as the only pegylated interferon to be approved in the EU and now in the US for the treatment of chronic hepatitis B," said Ciro Caravaggio, Head of the Pegasys Life Cycle team at Roche. "The commitment of Roche to conducting clinically meaningful research means that more patients worldwide have access to approved and efficacious treatment."

The studies on which the approval has been granted:

Pegasys has been studied in one of the largest clinical development programmes in chronic hepatitis B, which included three global studies in more than 1,500 patients from 19 countries. These trials have been conducted in patients with both forms of the disease- HBeAg-positive (most common in Asia and north Europe) and HBeAg-negative chronic hepatitis B (the more difficult to treat form of the disease in found mainly in the Mediterranean area).

The two large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative forms of chronic hepatitis B, demonstrated that 24 weeks after a defined 48 week period of therapy, more patients achieved a sustained response with PEGASYS than with lamivudine(1,2). Furthermore, these studies demonstrated that the addition of lamivudine to PEGASYS did not improve response rates over PEGASYS alone. Recent results from a long-term follow-up study presented at the 40th Annual meeting of the European Association for the Study of the Liver (EASL, 13-17 April in Paris)(3) indicate that patients with HBeAg-negative chronic hepatitis B who responded to treatment with PEGASYS maintained the benefit for at least a year after treatment was stopped.

The phase III study results in HBeAg-negative chronic hepatitis B were published in September 2004 in the New England Journal of Medicine(1). The results of the phase III study in patients with HBeAg-positive CHB were presented at the 2004 Annual Meeting of the American Association for the Study of Liver Diseases2. Both lead investigators have stated that the results of these trials warrant PEGASYS becoming the first-line treatment for HBeAg-positive or HBeAg-negative chronic hepatitis B.

About Pegasys
Pegasys is a highly effective hepatitis medication which has become the most prescribed hepatitis C medication in the US. With this new indication PEGASYS now becomes the first and only pegylated interferon approved for hepatitis B and hepatitis C including patients who are co-infected with HIV. In addition to the EU and US approvals, PEGASYS has also recently been approved for the treatment of chronic hepatitis B in China, Hong-Kong, New Zealand, Switzerland, Taiwan, Thailand and Turkey. More approvals are expected throughout 2005.

1. Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351:1206-17.

2. Lau GK, et al. Peginterferon alfa-2a (40KD) ( Pegasys(R)) monotherapy and in combination with lamivudine is more effective than lamivudine monotherapy in HBeAg-positive chronic hepatitis B: results from a large, multinational study. Hepatology, 2004; Vol. 40 (4); Suppl. 1:171A

3. Marcellin P, Lau GKK, Bonino F, et al. Sustained response to peginterferon α-2a (40 kDa) (PEGASYS(R)) in HBeAg-negative chronic hepatitis B. 1-year follow-up data from a large, randomized multinational study. Hepatology 2005;42 (Suppl 2):185.

Source: Roche

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