Scotland: Direct-acting antiviral agent therapy reduces the burden of HCV-related decompensated cirrhosis

12 April 2018, Paris, France: Two presentations given this week at The International Liver Congress™ 2018 in Paris, France illustrate the impact that DAAs can have in averting HCV-related liver disease, and reducing the clinical and economic burden of this chronic infection. The first presentation summarized data from Scottish national records providing country-level evidence of a reduction in HCV-related decompensated cirrhosis since the introduction of DAAs in 2014. The second presentation described modelling data based on clinical trials of glecaprevir/pibrentasvir and UK patient tracker data, and suggested that the health and economic benefits of DAAs may be increased if treatment is initiated at an earlier stage of disease.

Rapid advances in the field of HCV treatment have led to the availability of several DAAs that now offer a cure, in the form of a sustained virological response (SVR), for more than 90% of people with chronic HCV infection.15,16 The impact of DAAs on the incidence and cost of liver morbidity and mortality at the population level is not yet known.17 Scotland is home to an estimated 34,500 people chronically infected with HCV and is regarded as a world leader in facing this problem.18 The Hepatitis C Action Plan (2006-2011) and the Sexual Health and Blood Borne Virus Framework (2011-2020)19 have resulted in significant increases in HCV diagnosis and treatment over the past decade.18-6 Informed by modelling work, Scotland set the ambitious target of reducing the incidence of HCV-related decompensated cirrhosis by 75% between 2015 and 2020.7,8

The Scottish HCV Clinical and Diagnosis databases, linked with the national inpatient hospital database, provided data on the use of HCV therapy up to March 2017 and on the numbers of patients with a chronic HCV diagnosis that had presented and been admitted to hospital for the first time with decompensated cirrhosis during 2000-2016. Among 4,800 people initiated on HCV therapy in Scotland between April 2014 and March 2017, 83% were treated with DAAs and 94% achieved SVR. This scale up of therapy, compared with the 3 preceding years, was associated with a 29% and 39% reduction in first-time presentations for decompensated cirrhosis among those previously diagnosed with chronic HCV and those with chronic HCV at the time of admission, respectively.

'Scotland's national surveillance of HCV treatment and disease means we are ideally placed to examine the early impact of DAA treatment on HCV-related disease progression at a population level', explained Professor Sharon Hutchinson from Glasgow Caledonian University, UK. 'We have been able to show that scale up of therapy has resulted in substantially fewer patients presenting with decompensated cirrhosis but has highlighted the need to address comorbidities that pose a continued risk of liver disease progression in those clear of the virus'.

In the second study, a health state transition model of the natural history of HCV was developed to forecast liver-related clinical and economic outcomes over a lifetime. The model population and treatment efficacy data were based on clinical trials of glecaprevir/pibrentasvir. Genotype, fibrosis distribution and costs were based on Scottish patient tracker data and on literature review. Rates of decompensated cirrhosis, hepatocellular carcinoma, liver transplant and liver-related death were predicted to be lower if treatment was initiated when disease was mild (F0-1) rather than delayed until compensated cirrhosis was present. As a consequence, early versus delayed treatment resulted in lower lifetime costs, including those associated with extrahepatic manifestations (F0-1: £33,297; compensated cirrhosis: £61,204), and greater lifetime quality-adjusted life years (F0-1: 16.20; compensated cirrhosis: 10.05).

'This study shows the impact that delayed treatment can have on a patient's life, including consequences such as liver morbidity and mortality, as well as extrahepatic complications', said Dr Sammy Saab, Professor of Medicine and Surgery at the University of California, Los Angeles. 'Beyond benefits to the patients, early treatment can generate significant savings by reducing clinical risks and allowing for a shorter, 8-week duration of treatment across all genotypes'.

'The studies from Scotland are important because they discuss the impact of HCV therapy and cure on patient-relevant outcomes', said Prof. Markus Cornberg from the Hannover Medical School, Germany, and EASL Governing Board Member. 'Recently, the value of DAA therapies has been challenged by a Cochrane review. These data are therefore very important in documenting not only sustained virological response, but also the prevention of morbidity and mortality'.

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About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2018 will take place from 11¬-15 April 2018 at the Paris Convention Centre, Paris, France.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organization has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

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Onsite location reference

Session title: General Session III: Public Health
Time, date and location of session: 14. April 2018, 11:30 AM – 11:45 AM – Main Plenary
Presenter: Sharon Hutchinson, UK
Abstract: Reduction in the incidence of hepatitis C-related decompensated cirrhosis associated with national scale-up of direct-acting antiviral therapies targeting patients with advanced liver fibrosis
Presenter: Scott Johnson, USA
Abstract: Early versus delayed hepatitis C treatment provides increased health benefits at lower costs: a pan-genotypic cost-effectiveness analysis set in Scotland (1184)

Author disclosures

Abstract 4515: Outside the submitted work: Sharon Hutchinson reports personal fees from Gilead Sciences; Hamish Innes reports personal fees from Gilead Sciences; John Dillon reports grants and personal fees from Gilead, Merck Sharp & Dohme, AbbVie, and Janssen; Peter Hayes reports personal fees from Merck Sharp & Dohme, Gilead, AbbVie, Janssen, Bristol-Myers Squibb, and Pfizer, and grants and personal fees from Roche; Raymond Fox is an Advisory Board member for AbbVie, Gilead, and Merck Sharp & Dohme, and reports personal fees from Gilead, AbbVie, and Merck Sharp & Dohme; Stephen Barclay reports personal fees from Gilead and Merck Sharp & Dohme, and grants and personal fees from AbbVie; Nicholas Kennedy is an Advisory Board member for AbbVie, Gilead, and Merck Sharp & Dohme, and reports personal fees from Gilead, AbbVie, and Merck Sharp & Dohme.

Abstract 1184: Design, study conduct and financial support for the study were provided by AbbVie, Inc. AbbVie Inc. participated in the interpretation of data, and review and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Brett Pinsky and Yuri Sanchez Gonzalez are employees of AbbVie Inc. and may own stocks and/or options in the company. Dominic Mitchell and Scott J Johnson are employees of Medicus Economics, LLC. Dominic Mitchell is a contractor to Medicus Economics, LLC. Medicus Economics, LLC received consulting fees for research from AbbVie. Sammy Saab is a consultant to and serves on speaker bureaus for AbbVie Inc., Bristol-Myers Squibb, Gilead, Janssen, and Merck.

References

15. World Health Organization. Global health sector strategy on viral hepatitis 2016-2021. June 2016. Available from: http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en/. Last accessed: March 2018.

16. Scottish National Clinical Guidelines for the treatment of HCV in adults. Version 4.0, November 2017. Available from: http://www.hps.scot.nhs.uk/resourcedocument.aspx?resourceid=1598. Last accessed: March 2018.

17. Jakobsen JC, et al. Direct-acting antivirals for chronic hepatitis C. Cochrane Database Syst Rev. 2017;18:9.

18. The Hepatitis C Trust. Eliminating hepatitis C in Scotland: a call to action, 2018. Available from: http://www.hcvaction.org.uk/sites/default/files/resources/Eliminating%20Hepatitis%20C%20FINAL.pdf. Last accessed: March 2018.

19. Scottish Sexual Health and Blood Borne Virus Framework (2015-2020). Available from: http://www.gov.scot/Resource/0048/00484414.pdf. Last accessed: March 2018.

20. Hutchinson S, et al. Expansion of HCV treatment access to people who have injected drugs through effective translation of research into public health policy: Scotland's experience. Int J Drug Policy. 2015;26(11):1041-9.

21. Innes H, et al. Strategies for the treatment of hepatitis C in an era of interferon-free therapies: what public health outcomes do we value most? Gut. 2015;64(11):1800-9.

22. The Scottish Government hepatitis C treatment & therapies group report. Revised February 2017. Available from: http://www.gov.scot/Resource/0051/00515075.pdf. Last accessed March 2018.

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