Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir for Treating Chronic Hepatitis C (TA365)

Technology Appraisal Guidance No. 365

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Ombitasvir–paritaprevir–ritonavir with or without dasabuvir is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1, only if the company provides ombitasvir–paritaprevir–ritonavir and dasabuvir at the same price or lower than that agreed with the Commercial Medicines Unit.

Table 1 Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating adults with chronic hepatitis C

HCV genotype, liver disease stage

Treatment

Duration (weeks)

Recommendation according to treatment history

Untreated

Treated

1a, without cirrhosis

Ombitasvir–paritaprevir–ritonavir with dasabuvir and ribavirin

12

Recommended

1a, with compensated cirrhosis

Ombitasvir–paritaprevir–ritonavir with dasabuvir and ribavirin

24

Recommended

1b, without cirrhosis

Ombitasvir–paritaprevir–ritonavir with dasabuvir

12

Recommended

1b, with compensated cirrhosis

Ombitasvir–paritaprevir–ritonavir with dasabuvir and ribavirin

12

Recommended

4, without cirrhosis

Ombitasvir–paritaprevir–ritonavir with ribavirin

12

Recommended

4, with compensated cirrhosis

Ombitasvir–paritaprevir–ritonavir with ribavirin

24

Recommended

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.

 


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/TA365

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

Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C

Issue Date: November 2015


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