Daclatasvir for Treating Chronic Hepatitis C (TA364)

Technology Appraisal Guidance No. 364

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Daclatasvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1, only if the company provides daclatasvir at the same price or lower than that agreed with the Commercial Medicines Unit.

Table 1 Daclatasvir for treating adults with chronic hepatitis C

HCV genotype, liver disease stage

Treatment

Duration (weeks)

Recommendation according to treatment history

Untreated

Treated

Interferon-ineligible or intolerant

1, without cirrhosis

Daclatasvir + sofosbuvir

12

Recommended only if the person has significant fibrosis

Recommended only if the person has significant fibrosis

Recommended only if the person has significant fibrosis

4, without cirrhosis

Daclatasvir + sofosbuvir

12

Not recommended

Recommended only if the person has significant fibrosis

Recommended only if the person has significant fibrosis

1 or 4, with compensated cirrhosis

Daclatasvir + sofosbuvir (with or without ribavirin)

24

Not recommended

Not recommended

Recommended

3, without cirrhosis

Daclatasvir + sofosbuvir

12

Not recommended

Not recommended

Recommended only if the person has significant fibrosis

3, with compensated cirrhosis

Daclatasvir + sofosbuvir + ribavirin

24

Not recommended

Not recommended

Recommended

4

Daclatasvir + peginterferon alfa + ribavirin

24

Recommended only if the person has significant fibrosis or compensated cirrhosis

Recommended only if the person has significant fibrosis or compensated cirrhosis

Not applicable

Abbreviation: HCV, hepatitis C virus.

Significant fibrosis is defined as METAVIR fibrosis stages F3 and F4.

Treated – the person's hepatitis C has not adequately responded to interferon-based treatment.

1.2 It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.

1.3 People whose treatment with daclatasvir is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

 


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/TA364

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

Daclatasvir for treating chronic hepatitis C

Issue Date: November 2015


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