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Sofosbuvir for Treating Chronic Hepatitis Hepatitis C

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Sofosbuvir for Treating Chronic Hepatitis Hepatitis C Sofosbuvir for treating chronic hepatitis C Technology appraisal guidance Published: 25 February 2015 nice.org.uk/guidance/ta330 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights). Sofosbuvir for treating chronic hepatitis C (TA330) Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance are at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 2 of conditions#notice-of-rights). 103 Sofosbuvir for treating chronic hepatitis C (TA330) Contents 1 Guidance ......................................................................................................................................................................... 5 Table 1 Sofosbuvir for treating adults with chronic hepatitis C ................................................................................ 5 2 The technology ............................................................................................................................................................ 7 3 The company's submission ...................................................................................................................................... 8 Evidence in people with genotype 1, 4, 5 or 6 HCV ....................................................................................................... 9 Evidence in people with genotype 2 or 3 HCV................................................................................................................. 11 People with HIV and HCV co-infection .............................................................................................................................. 16 People awaiting liver transplant ............................................................................................................................................ 17 Adverse effects of treatment .................................................................................................................................................. 18 Health-related quality of life ................................................................................................................................................... 18 Mixed treatment comparison.................................................................................................................................................. 19 Evidence Review Group comments...................................................................................................................................... 20 Cost effectiveness ....................................................................................................................................................................... 20 Results .............................................................................................................................................................................................. 23 Evidence Review Group comments...................................................................................................................................... 27 Additional exploratory ERG analyses .................................................................................................................................. 28 4 Consideration of the evidence ............................................................................................................................... 47 Clinical effectiveness.................................................................................................................................................................. 49 Cost effectiveness ....................................................................................................................................................................... 54 Genotype 1 ..................................................................................................................................................................................... 60 Genotype 2 ..................................................................................................................................................................................... 63 Genotype 3 ..................................................................................................................................................................................... 63 Genotypes 4, 5 and 6 .................................................................................................................................................................. 68 Summary of Appraisal Committee's key conclusions .................................................................................................... 76 5 Implementation............................................................................................................................................................ 88 6 Recommendations for further research............................................................................................................. 93 7 Review of guidance..................................................................................................................................................... 94 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 3 of conditions#notice-of-rights). 103 Sofosbuvir for treating chronic hepatitis C (TA330) 8 Appraisal Committee members, guideline representatives and NICE project team ....................... 95 Appraisal Committee members ............................................................................................................................................. 95 Guideline representatives ....................................................................................................................................................... 98 NICE project team ....................................................................................................................................................................... 98 9 Sources of evidence considered by the Committee. ..................................................................................... 99 About this guidance........................................................................................................................................................ 102 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 4 of conditions#notice-of-rights). 103 Sofosbuvir for treating chronic hepatitis C (TA330) 1 Guidance 1.1 Sofosbuvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1. Table 1 Sofosbuvir for treating adults with chronic hepatitis C Sofosbuvir in combination with Sofosbuvir in combination with ribavirin peginterferon alfa and ribavirin Treatment Treatment Genotype Recommendation Recommendation history history Adults with genotype 1 All Recommended All Not recommended HCV Only recommended for people Treatment- Adults with who are intolerant to or ineligible Not licensed for naive genotype 2 All for interferon this population HCV Treatment- Recommended experienced Only Only recommended for people Treatment- recommended Treatment- with cirrhosis who are intolerant naive for people with naive Adults with to or ineligible for interferon genotype 3 cirrhosis HCV Only recommended for people Treatment- Treatment- Recommended with cirrhosis who are intolerant experienced experienced to or ineligible for interferon Only Adults with recommended genotype 4, All All Not recommended for people with 5 or 6 HCV cirrhosis HCV – hepatitis C virus Treatment-naive – the person has not had treatment for chronic hepatitis C Treatment-experienced – the person's hepatitis C has not adequately responded to interferon-based treatment © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 5 of conditions#notice-of-rights). 103 Sofosbuvir for treating chronic hepatitis C (TA330) 1.2 People currently receiving treatment initiated within the NHS with sofosbuvir that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician
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