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27 November 2013

NICE's 300th technology appraisal guidance recommends drugs to treat chronic hepatitis C in children and young people

In its 300th technology appraisal guidance NICE has recommended peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.

In its 300th technology appraisal guidance published today NICE has recommended peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.

Hepatitis C is a blood-borne virus that infects the liver. Children and young people get the disease primarily from their mothers at birth. If the virus is not cleared from the body after an acute infection (defined as the first 6 months following initial infection) the condition can progress to chronic hepatitis C (long term infection, lasting more than 6 months). Although hepatitis C rarely causes serous liver damage in children, if left untreated chronic hepatitis C infection increases the risk of scarring of the liver(fibrosis and cirrhosis), liver failure and liver cancer in the future. Peginterferon alfa-2a (Pegasys, Roche Products) and peginterferon alfa-2b (ViraferonPeg, Merck Sharp and Dohme (MSD)), in combination with ribavirin are the only treatments currently licensed in the UK for the treatment of chronic hepatitis C in children and adolescents. They are also licensed for the treatment of chronic hepatitis C in adults.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The independent Appraisal Committee concluded that treatment with peginterferon alfa and ribavirin can decrease the hepatitis C virus to undetectable levels, effectively providing a cure for the disease. Early successful treatment is also likely to lessen the social stigma that can be associated with hepatitis C infection later in life. By widening access to these drugs this guidance will give clinicians and people living with hepatitis C more treatment options."

Ends

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Notes to Editors

About the guidance

1. The guidance will be available from 00:01hrs on Wednesday 27 November from the NICE website

Embargoed copies of the guidance are available from the NICE press office on request.

2. Estimates from the Health Protection Agency in 2011 indicate that 26 people aged 1 year or less and 21 people between the ages of 1 and 14 years were newly diagnosed with HCV in England in 2010. Estimates for chronic infection in children and young people are not available.

3. The Assessment Group calculated that, based on an average age of 11 years, a body weight of 35.5 kg and a body surface area of 1.19 m2, a 24-week course of peginterferon alfa-2a and ribavirin costs approximately £3700 while a 48-week course of treatment costs approximately £7400.

4. A 24-week course of peginterferon alfa-2b and ribavirin oral solution costs approximately £4000, while a 48-week course of treatment costs approximately £8100.

5. Ribavirin is manufactured by Roche Products (Copegus) and MSD (Rebetol). Each product is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa or interferon alfa. The marketing authorisation for Copegus does not include specific recommendations for use in children. Copegus should be administered only in combination with the interferon products made by Roche Products (peginterferon alfa-2a or interferon alfa-2a). Rebetol (MSD) is available as an oral solution and 200 mg hard capsules and has a UK marketing authorisation for children and adolescents aged 3 years and older in combination only with MSD products peginterferon alfa-2b or interferon alfa-2b.

6. The cost effectiveness results suggested that peginterferon alfa-2a and peginterferon alfa-2b (each in combination with ribavirin were more effective and less costly than best supportive care.

7. The comparison between peginterferon alfa-2a and peginterferon alfa-2b was not robust enough for the Committee to recommend one treatment over the other.

8. NICE technology appraisals apply across the NHS in England and Wales.

About NICE

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