Ledipasvir-Sofosbuvir for Treating Chronic Hepatitis C (TA363)

on the 25 November 2015

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
HCV genotype, liver disease stage	Duration (weeks)	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.
1, with compensated cirrhosis	24	Not recommended	Not recommended
4, without cirrhosis	12	Not recommended	Recommended
4, without cirrhosis	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.
4, with compensated cirrhosis	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