European Commission has approved Pegasys ( Peginterferon alfa-2a ) 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 achieves sustained remission in a significant number of patients with chronic hepatitis B following a defined 48-week treatment period.

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.

In contrast to Lamivudine, Pegasys works with a dual mode of action: it stimulates the immune system as well as inhibits virus replication.
Pegasys offers the advantage of a finite treatment duration and lasting remission from the disease.

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.

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.

Source: Roche, 2005

XagenaMedicine2005