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Pegasys recommended as front line hepatitis B treatment

Published on 23/02/06 at 10:22am

Roche's Pegasys is set to be used more widely in England and Wales to treat hepatitis B following the release of new NICE guidelines.

The company received European marketing approval to treat the condition in February 2005, and remains the only pegylated drug licensed, keeping one step ahead of Schering Plough's rival hepatitis drug PegIntron.

The guidance recommends Pegasys (peginterferon alfa-2a) as a first line treatment for the condition for the first time ever, putting it alongside older drugs such as lamivudine and non-pegylated interferon alfa drugs, Schering-Plough's Viraferon and Roche's own Roferon-A.

Pegylated formulations prolong the effects of the drug, producing greater clinical benefit and reducing the number of injections and treatment duration compared to existing drugs.

Manufacturer Roche says this is particularly important since resistance to lamivudine occurs in more than 70% of cases after five years of treatment.

Another drug, Gilead's Hepsera has also been recommended by NICE as a second line treatment for the disease if the other drugs are not effective or tolerated.

The guidance

  • Peginterferon alfa-2a (Roche's Pegasys) is recommended as an option for the initial treatment of adults with chronic hepatitis B (HBeAg-positive or HBeAg-negative), within its licensed indications.
  • Adefovir dipivoxil (Gilead's Hepsera) is recommended as an option for the treatment of adults with chronic hepatitis B (HBeAg-positive or HBeAg-negative) within its licensed indications if: treatment with interferon alfa or peginterferon alfa-2a has been unsuccessful; or a relapse occurs after successful initial treatment; or treatment with interferon alfa or peginterferon alfa-2a is poorly tolerated or contraindicated.
  • Adefovir dipivoxil should not normally be given before treatment with lamivudine. It may be used either alone or in combination with lamivudine when: treatment with lamivudine has resulted in viral resistance; or lamivudine resistance is likely to occur rapidly (for example, in the presence of highly replicative hepatitis B disease), and development of lamivudine resistance is likely to have an adverse outcome (for example, if a flare of the infection is likely to precipitate decompensated liver disease).

NICE said treatment with the drugs should be initiated only by experts in the field, with GPs involved in shared-care arrangements as appropriate.

The guidance does not apply to people with chronic hepatitis B known to be co-infected with hepatitis C, hepatitis D or HIV.

An estimated 350 million people globally are infected with viral chronic hepatitis B, with around 20 to 25% expected to eventually develop serious liver disease including cirrhosis and liver cancer.

Professor Arie Zuckerman, chairman of the newly launched Hepatitis B Foundation UK said there were an estimated 180,000 patients with the condition in the UK, and said early treatment with peginterferon alpha-2a and other antivirals drugs was vital.

"This guidance will support clinicians wishing to choose the best treatment for their patients and is to be warmly welcomed," he said.

Pegasys is one of Roche's top performing brands, with 2005 sales increasing 17% to CHF1.4 billion; growth in European sales was particularly strong, up 24%.

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