Regulatory

Britain's NICE backs Roche's Pegasys and Gilead's Hepsera for hepatitis B

Last Updated: 2006-02-22 11:00:34 -0400 (Reuters Health)

LONDON (APM) - Britain's health cost-effectiveness watchdog, NICE, on Wednesday backed first-line use of Roche's Pegasys (peginterferon alfa-2a) and second-line use of Gilead's Hepsera (adefovir dipivoxil) for the treatment of chronic hepatitis B.

In a statement, the National Institute for Health and Clinical Excellence said peginterferon alfa-2a was "recommended as an option for the initial treatment of adults with chronic hepatitis B within its licensed indications".

Adefovir dipivoxil was recommended if treatment with interferon alfa or peginterferon alfa-2a was unsuccessful or was poorly tolerated or contraindicated. It should not normally be given before treatment with lamivudine.

The guidance does not apply to patients known to be co-infected with hepatitis C, hepatitis D or HIV, NICE added.

The Department of Health estimates that 180,000 people in the UK are affected by chronic hepatitis B though only a small fraction of those with the condition know they have it.

"We hope that today's excellent guidance will prompt a public health campaign that will alert people to this condition and encourage them to get tested, diagnosed, treated and protected," said Professor Roger Williams, Director of the Foundation for Liver Research, in the NICE statement.

Globally, Pegasys had sales of 1.4 billion Swiss francs (0.9 billion euros) in 2005 and Roche forecasts peak annual sales of around 2 billion francs. Hepsera sales rose 43% to $51.2 million in the fourth quarter of 2005.