European approval of Pegasys for the treatment of chronic hepatitis B

Roche has announced that the EU Commission has approved Pegasys (peginterferon alfa-2a (40KD)) for the treatment of chronic hepatitis B.

The approval is granted for both types of the disease – HBeAg-positive and HBeAg-negative chronic hepatitis B. Pegasys offers the hope of a treatment-free life for thousands of people with chronic hepatitis B as this innovative drug has been shown to achieve lasting remission for a significant proportion of patients.

“Pegasys is well-known to physicians as a highly effective treatment for chronic hepatitis C and we are glad the EU Commission has recognised the benefits it also offers to patients with chronic hepatitis B,” said William M. Burns, CEO of Roche’s Pharmaceutical Division. “Pegasys is the only pegylated interferon with this indication and the approval means that physicians now have a medication that can be taken for a defined period of time and offers long-term remission after stopping treatment.”

Hepatitis B is a major public health concern with data suggesting that globally, more than 350 million people are infected with the virus and approximately one million die each year from the disease. In the Mediterranean countries and Eastern Europe the HBeAg-negative form of chronic hepatitis B, which is more difficult-to-treat and associated with a poorer prognosis, is particularly prevalent.

“Pegasys achieves sustained remission in a significant number of patients with chronic hepatitis B following a defined 48-week treatment period,” said Professor Patrick Marcellin, Hepatologist at Hôpital Beaujon, Clichy, France and one of the lead investigators of the Phase III global studies. “In clinical trials, Pegasys has demonstrated its effectiveness against both forms of the disease, and has demonstrated superior benefits against the two leading medications used to treat it today, lamivudine and conventional interferon. These results support its use as first line therapy for chronic hepatitis B.”

In contrast to lamivudine, Pegasys works with a dual mode of action: it stimulates the immune system as well as inhibits virus replication. This offers physicians a new option with the advantages of a finite treatment duration and lasting remission from the disease, avoiding the burden of putting their patients on a life-long therapy.

Pegasys was 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.

Pegasys has been proven twice as effective as conventional interferon for the treatment of the most common, HBeAg-positive, form of chronic hepatitis B in a multinational phase II trial. These findings were published in the July 2003 Journal of Viral Hepatitis.1

In addition, two large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative forms of chronic hepatitis B, demonstrated that after 48 weeks of therapy, more patients achieved a sustained response with Pegasys than with lamivudine. Furthermore, these studies demonstrated that the addition of lamivudine to Pegasys did not improve response rates over Pegasys alone.

The phase III study results in HBeAg-negative chronic hepatitis B were published in September 2004 in the New England Journal of Medicine.2 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 Diseases.3 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.

Pegasys, a new generation hepatitis therapy that is different by design, has already become the worldwide market leader in hepatitis C. Now approved in the European Union for the treatment of chronic hepatitis B, Pegasys has a dual immunomodulatory and antiviral mode of action. The improved pharmacokinetic profile ensures drug plasma concentrations are maintained at constant levels throughout the one week dosing interval. Pegasys therapy in chronic hepatitis B is given once weekly as a 180 µg subcutaneous injection for a 48-week period.

Pegasys has recently been approved for the treatment of chronic hepatitis B in the European Union, Hong-Kong, India, New Zealand, Switzerland, Taiwan and Thailand. Approval in the US is expected this year.