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Brief Summary

GUIDELINE TITLE

Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C. London (UK): National Institute for Clinical Excellence (NICE); 2004 Jan. 38 p. (Technology appraisal; no. 75).

GUIDELINE STATUS

This is the current release of the guideline.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • 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.
  • 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
    • previously received peginterferon alfa monotherapy only and responded at the end of treatment but subsequently relapsed, or did not respond at the end of treatment.
  • People currently being treated with interferon alfa, either as combination therapy or monotherapy, may be switched to the corresponding therapy with peginterferon alfa.
  • Treatment for the groups identified in the first two recommendations (see above) 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 original guideline document) 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.
  • People satisfying the conditions in the first two recommendations (see above) 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.
  • 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.
  • There is insufficient evidence to recommend combination therapy using peginterferon alfa or interferon alfa in people who:
    • have previously been treated with combination therapy using peginterferon alfa, and/or
    • are younger than 18 years of age, and/or
    • 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.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations for clinical effectiveness are based on the results of six published randomized controlled trials.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C. London (UK): National Institute for Clinical Excellence (NICE); 2004 Jan. 38 p. (Technology appraisal; no. 75).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Jan

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Dr Jane Adam, Radiologist, St George's Hospital, London; Dr Sunil Angris, General Practitioner, Waterhouses Medical Practice, Staffordshire; Dr Darren Ashcroft, Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical Sciences, University of Manchester; Professor David Barnett (Chair), Professor of Clinical Pharmacology, University of Leicester; Dr Peter Barry, Consultant in Paediatric Intensive Care, Leicester Royal Infirmary; Professor John Brazier, Health Economist, University of Sheffield; Professor John Cairns, Professor of Health Economics, Health Economics Research Unit, University of Aberdeen; Professor Mike Campbell, Statistician, Institute of General Practice & Primary Care, Sheffield; Dr Mark Chakravarty, Head of Government Affairs and NHS Policy, Procter and Gamble Pharmaceuticals (UK) Ltd, Egham, Surrey; Dr Peter I Clark, Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Wirral, Merseyside; Dr Mike Davies, Consultant Physician, University Department of Medicine & Metabolism, Manchester Royal Infirmary; Professor Jack Dowie, Health Economist, London School of Hygiene; Dr Paul Ewings, Statistician, Taunton & Somerset NHS Trust, Taunton; Ms Sally Gooch, Director of Nursing, Mid-Essex Hospital Services NHS Trust, Chelmsford; Professor Robert Kerwin, Professor of Psychiatry and Clinical Pharmacology, Institute of Psychiatry, London; Dr Stephen Saltissi, Consultant Cardiologist, Royal Liverpool University Hospital; Mr Miles Scott, Chief Executive, Harrogate Health Care NHS Trust; Professor Andrew Stevens (Vice-Chair), Professor of Public Health, University of Birmingham; Professor Mary Watkins, Professor of Nursing, University of Plymouth; Dr Norman Waugh, Department of Public Health, University of Aberdeen

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N0427. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Appendix C of the original guideline document.

PATIENT RESOURCES

The following is available:

  • The use of interferon alfa, peginterferon alfa and ribavirin for the treatment of chronic hepatitis C. Understanding NICE guidance - information for people with chronic hepatitis C, their families and carers, and the public. London (UK): National Institute for Health and Clinical Excellence (NICE); 2004 Jan. 12 p. (Technology appraisal 75).

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the Department of Health Publications Order Line 0870 1555 455. ref: N0370. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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