Technology Appraisal Guidance No. 200
Source: National Institute for Health and Care Excellence
This guidance should be read in conjunction with the following NICE guidance:
- NICE technology appraisal guidance 75 (TA75) ‘Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C’ (which covers moderate to severe hepatitis C)
- NICE technology appraisal guidance 106 (TA106) ‘Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C’.
This appraisal addresses extensions to the marketing authorisations for peginterferon alfa-2a and peginterferon alfa-2b. This guidance updates and replaces:
- section 1.2, bullet 3 only, of TA75
- section 1.4 of TA75 for adults who are eligible for shortened courses of combination therapy (as described in section 1.2 of the current guidance)
- section 1.7, bullet 1 only, of TA75
- sections 1.4 and 1.5 of TA106.
All other recommendations in TA75 and TA106 still stand.
1.1 Combination therapy with peginterferon alfa (2a or 2b) and ribavirin is recommended as a treatment option for adults with chronic hepatitis C:
- who have been treated previously with peginterferon alfa (2a or 2b) and ribavirin in combination, or with peginterferon alfa monotherapy, and whose condition either did not respond to treatment or responded initially to treatment but subsequently relapsed or
- who are co-infected with HIV.
1.2 Shortened courses of combination therapy with peginterferon alfa (2a or 2b) and ribavirin are recommended for the treatment of adults with chronic hepatitis C who:
- have a rapid virological response to treatment at week 4 that is identified by a highly sensitive test and
- are considered suitable for a shortened course of treatment.
1.3 When deciding on the duration of combination therapy, clinicians should take into account the licensed indication of the chosen drug (peginterferon alfa-2a or peginterferon alfa-2b), the genotype of the hepatitis C virus, the viral load at the start of treatment and the response to treatment (as indicated by the viral load).
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 http://guidance.nice.org.uk/TA200
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 email@example.com and quoting reference number N2302. It is also available on the Internet at http://guidance.nice.org.uk/TA200/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: firstname.lastname@example.org
Peginterferon Alfa and Ribavirin for the Treatment of Chronic Hepatitis C (Part Review of NICE Technology Appraisal Guidance 75 and 106).
Issue Date: September 2010
Review Date: July 2013