Ledipasvir-Sofosbuvir for Treating Chronic Hepatitis C (TA363)

Technology Appraisal Guidance No. 363

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Ledipasvir–sofosbuvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1.

Table 1 Ledipasvir–sofosbuvir for treating adults with chronic hepatitis C

HCV genotype, liver disease stage

Duration (weeks)

Recommendation according to treatment history

Untreated

Treated

Ledipasvir–sofosbuvir

1, without cirrhosis

8

Recommended

Not the licensed regimen for this population

12

Not recommended

Recommended

24

Not the licensed regimen for this population

Not recommended

1, with compensated cirrhosis

12

Recommended

Recommended only if all the following criteria are met:

  • Child–Pugh class A

  • platelet count of 75,000/mm3 or more

  • no features of portal hypertension

  • no history of an HCV-associated decompensation episode

  • not previously treated with an NS5A inhibitor.

24

Not recommended

Not recommended

4, without cirrhosis

12

Not recommended

Recommended

24

Not the licensed regimen for this population

Not recommended

4, with compensated cirrhosis

12

Recommended

Recommended only if all the following criteria are met:

  • Child–Pugh class A

  • platelet count of 75,000/mm3 or more

  • no features of portal hypertension

  • no history of an HCV-associated decompensation episode

  • not previously treated with an NS5A inhibitor.

24

Not recommended

Not recommended

Ledipasvir–sofosbuvir plus ribavirin

1

Not the licensed regimen for this population

3

24

Not recommended

4

Not the licensed regimen for this population

Abbreviation: HCV, hepatitis C virus.

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 ledipasvir–sofosbuvir 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/TA363

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

Ledipasvir-sofosbuvir for treating chronic hepatitis C 

Issue Date: November 2015


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