Interferon Alfa (Pegylated and Non-Pegylated) and Ribavirin for the Treatment of Chronic Hepatitis C (TA75)

Technology Appraisal Guidance No. 75

Source: National Institute for Health and Care Excellence

This guidance is a review and extension of Technology Appraisal Guidance No. 14 issued in October 2000.

This guidance has been partially updated by 'Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (NICE technology appraisal guidance 200) and 'Peginterferon alfa and ribavirin for treating chronic hepatitis C in children and young people' (NICE technology appraisal guidance 300), as shown below. It is extended by 'Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C' (NICE technology appraisal guidance 106).

1. Guidance

1.1 Combination therapy with peginterferon alfa and ribavirin is recommended within its licensed indications for the treatment of people aged 18 years and over with moderate to severe chronic hepatitis C (CHC), defined as histological evidence of significant scarring (fibrosis) and/or significant necrotic inflammation.

1.2 People with moderate to severe CHC are suitable for treatment if they have:

  • not previously been treated with interferon alfa or peginterferon alfa, or

  • been treated previously with interferon alfa (as monotherapy or in combination therapy), and/or

  • [replaced by NICE technology appraisal guidance 200]

1.3 People currently being treated with interferon alfa, either as combination therapy or monotherapy, may be switched to the corresponding therapy with peginterferon alfa.

1.4 Treatment for the groups identified in Sections 1.1 and 1.2 should be as follows.

  • People infected with hepatitis C virus (HCV) of genotype 2 and/or 3 should be treated for 24 weeks.
  • For people infected with HCV of genotype 1, 4, 5 or 6, initial treatment should be for 12 weeks. Only people showing, at 12 weeks, a reduction in viral load to less than 1% of its level at the start of treatment (at least a 2-log reduction, see Section 4.1.2.5 of the full guidance) should continue treatment until 48 weeks. For people in whom viral load at 12 weeks exceeds 1% of its level at the start of treatment, treatment should be discontinued.
  • People infected with more than one genotype that includes one or more of genotypes 1, 4, 5, or 6 should be treated as for genotype 1.

1.5 People satisfying the conditions in Sections 1.1 and 1.2 but for whom ribavirin is contraindicated or is not tolerated should be treated with peginterferon alfa monotherapy. Regardless of genotype, individuals should be tested for viral load at 12 weeks, and if the viral load has reduced to less than 1% of its level at the start of treatment, treatment should be continued for a total of 48 weeks. If viral load has not fallen to this extent, treatment should stop at 12 weeks.

1.6 People for whom liver biopsy poses a substantial risk (such as those with haemophilia, or those who have experienced an adverse event after undergoing a previous liver biopsy), and people with symptoms of extra-hepatic HCV infection sufficient to impair quality of life, may be treated on clinical grounds without prior histological classification.

1.7 There is insufficient evidence to recommend combination therapy using peginterferon alfa or interferon alfa in people who:

  • [replaced by NICE technology appraisal guidance 200]

  • [replaced by NICE technology appraisal guidance 300]

  • have had a liver transplantation. Treatment of CHC recurrence after liver transplantation (whether or not the person had been treated with interferon alfa or peginterferon alfa therapy at any time before transplantation) should be considered as experimental and carried out only in the context of a clinical trial.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at www.nice.org.uk/page.aspx?o=101627

An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N0427. It is also available on the Internet at http://www.nice.org.uk/Guidance/TA75/QuickRefGuide/pdf/English.

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Interferon Alfa (Pegylated and Non-Pegylated) and ribavirin for the Treatment of Chronic Hepatitis C.
Issue Date: January 2004
Review Date: November 2006


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