Action Hepatitis Canada is pleased to present the first of three position papers we plan to produce this fall. Special thanks to our Policy Analyst Claire Checkland for her hard work, and to the Executive Committee for their input.
Access to Hepatitis C Treatment
Action Hepatitis Canada (AHC) believes that Direct-Acting Antiviral (DAA) medications should be accessible to all Canadians who are living with chronic hepatitis C (HCV) regardless of their stage of disease progression.
Public reimbursement restrictions based either on fibrosis level or presence of cirrhosis should be eliminated. Reimbursement policies should be based on clinical evidence, ensuring early access to treatment for all people living with HCV.
HCV is a life-threatening virus that attacks the liver and can cause liver fibrosis, scarring of the liver (cirrhosis), liver cancer, and death from liver failure. As of 2011, approximately 250,000 Canadians were living with HCV, with thousands of new infections occurring every year[i].
Prior to 2014, the standard treatment for HCV was a 24-48 week regimen of injections of pegylated interferon administered weekly combined with twice daily tablets of ribavirin. This therapy was associated with significant toxicity and side-effects and had a low cure rate (or Sustained Virologic Response) of 40%-50%[ii].
New treatments are now available. These new Direct-Acting Antiviral (DAA) medicines are highly tolerable, are taken for a shorter duration (as little as 8 to 12 weeks) and result in a cure rate of more than 90%.[iii]
Many provincial governments in Canada have placed strict restrictions on access to DAA treatments limiting eligibility for public reimbursement of treatment costs to people whose virus has progressed to cause significant fibrosis and damage to their liver.
These restrictive criteria are not based in best practice or medical evidence and are in opposition to recommendations made by expert bodies in the field of Hepatology including the Canadian Association for the Study of the Liver and the American Association for the Study of Liver Diseases.
Requiring the virus to progress to advanced liver disease before treatment denies early access to a cure and raises the risk of future medical complications caused by HCV[iv].
Benefits of treatment at time of diagnosis
There is an abundance of evidence demonstrating the benefits of treating HCV as early as possible before the development of severe liver disease or other preventable complications.
Early treatment results in:
- a higher likelihood of successfully curing the virus through the attainment of a Sustained Virologic Response (SVR);[v]
- the prevention of the development of liver disease and a decrease in liver inflammation[vi];
- a reduction in liver-related conditions, including end-stage liver disease and liver cancer; [vii]
- a reduction in the risk of liver-related mortality and liver transplantation;[viii]
- a reduction in all-cause mortality[ix]
- lesser likelihood of transmission of HCV to others;[x],[xi]
- less required follow-up care;[xii]
- substantial improvements to the quality of physical, emotional and social health.[xiii]
Without early treatment, the incidence of these complications[xiv] and the prevalence of chronic hepatitis C will increase significantly in the coming years[xv].
Eliminating Hepatitis C in Canada
HCV is curable. Early intervention and treatment is highly cost-effective and crucial to reducing morbidity and mortality levels.[xvi],[xvii]
Through appropriate testing, diagnosis and treatment, we now have both the opportunity and the ability to eliminate hepatitis C in Canada. The AHC calls on governments from all jurisdictions in Canada to embrace this opportunity.
[i] RTrubnikov M, Yan P, Archibald C. Estimated Prevalence of Hepatitis C Virus infection in Canada, 2011. Canada Communicable Disease Report: Volume 40-19, December 18, 2014. Available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/14vol40/dr-rm40-19/surveillance-b-eng.php
[ii] RP Myers, H Shah, KW Burak, C Cooper, JJ Feld. An update on the management of chronic hepatitis C: 2015 consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol Hepatol 2015 In Press
[iii] Kevin B Laupland MD MSc FRCPC, Louis Valiquette MD MSc FRCPC. The dollars and sense of chronic hepatitis C infection management. Canadian Journal of infectious Diseases and Medial Microbiology. Vol 26 No 3 May/June 2015
[iv] Mikel Theobald. Dangers of Delaying Hepatitis C Treatment. Accessed September 15, 2015 at http://www.everydayhealth.com/news/dangers-delaying-hepatitis-c-treatment/
[v] American Association for the Study of Liver Diseases. Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed online October 1, 2015 at http://www.hcvguidelines.org/
[vi] RP Myers, H Shah, et al. An update on the management of chronic hepatitis C
[vii] American Association for the Study of Liver Diseases. Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed online October 1, 2015 at http://www.hcvguidelines.org/
[viii] Adriaan J van der Meer, MD; Bart J. Veldt, MD, PhD; Jordan J Feld, MD, PhD; et al. Association Between Sustained Virological Response and All-Cause Mortality Among Patients With Chronic Hepatitis C and Advanced Hepatic Fibrosis. JAMA. 2012; 308(24):2584-2593. Doi:10.1001/jama.2012.144878
[ix] American Association for the Study of Liver Diseases. Recommendations for Testing, Managing, and Treating Hepatitis C.
[x] RP Myers, H Shah, et al. An update on the management of chronic hepatitis C
[xi] C Zahnd, LP Salazar-Vizcaya, J-F Dufour, et al. (Swiss HIV and Hepatitis C Cohort Studies Team). Impact of Deferring HCV Treatment on Liver-Related events in HIV+ patients. 2015 Conference on Retroviruses and Opportunistic Infections. Seattle, February 23-24, 2015.
[xii] American Association for the Study of Liver Diseases. Recommendations for Testing, Managing, and Treating Hepatitis C.
[xiii] Younossi ZM, Stepanova M, Henry L, et al. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2013.
[xiv] C Zahnd, LP Salazar-Vizcaya, J-F Dufour, et al. (Swiss HIV and Hepatitis C Cohort Studies Team). Impact of Deferring HCV Treatment on Liver-Related events in HIV+ patients. 2015 Conference on Retroviruses and Opportunistic Infections. Seattle, February 23-24, 2015.
[xv] RP Myers, MD MSc; Mel Krajden, MD; Marc Bilodeau, MD; et al. Burden of disease and cost of chronic hepatitis C virus infection in Canada. Canadian Journal Gastroenterol Hepatol. 2014 May; 28(5): 243-250.
[xvi] Leidner AJ, Chesson HW, Xu F, Ward JW, Spradling PR, Holmberg SD. Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease. Hepatology. 2015;61:1860-9. [PMID: 25677072]
[xvii] David Rein, John Wittenborn, Bryce Smith, Danielle Liffman, John Ward. The Cost-effectiveness, Health Benefits, and Financial Cost of New Antiviral Treatments for Hepatitis C Virus. Clinical Infectious Diseases. 2015;61(2):157-68.