First Canadian study demonstrates potential to remove patients from active liver transplant list after curing hepatitis C

London, ON - Researchers with the Multi-Organ Transplant Program at London Health Sciences Centre and the Lawson Health Research Institute have been able to remove
one-third (33 per cent) of patients from the active liver transplant waiting list by “curing” them of their Hepatitis C disease.  This is the first Canadian data that demonstrates the benefit of treating and curing patients with the hepatitis C virus (HCV) in advanced stages of liver disease that have also been assessed for, and would otherwise have received, radical and life-saving liver transplantation.  

“For years, severe liver disease from chronic infection with Hepatitis C has been the most common indication for liver transplantation, not only in Canada, but also worldwide,” said
Dr. Paul Marotta, Medical Director Liver Transplantation, Multi-Organ Transplant Program, London Health Sciences Centre.  “These impressive results mean that not only will this save these patients from the need for transplantation, but will also allow the scarce resource of donor organs to go to others who are in urgent need – this is an incredible outcome,” said Dr. Marotta. 

In this clinical study, 23 patients with advanced liver disease from HCV, were identified as candidates for liver transplantation.  All patients were prescribed oral anti-viral (sofosbuvir-based) treatment regimens.  At the time of the interim results, 13 patients had completed HCV treatment and 10 additional patients were soon to complete HCV treatment. 

Of the 13 patients who had completed HCV treatment, nine patients had achieved a cure of their chronic hepatitis C (SVR 12), and four more had completed treatment and were pending a result to confirm a cure (SVR 12).  Of the nine cured patients, three (33 per cent) were removed from the liver transplant list due to the vast improvements in their disease severity scores.  No significant adverse events were reported.

“HCV therapy that is now available for these patients leads not only to cure in a large percentage, but also to regression of liver disease suggesting that the days of HCV dominating the liver transplant list are numbered,” said Dr. Marotta.  “These early and impressive results show that we can cure HCV in patients that have advanced liver disease and eliminate the need for liver transplantation.  These newer treatment strategies are exceedingly well tolerated, have an excellent safety profile, and have high efficacy,” added Dr. Marotta.  

According to the most recent data from the Canadian Institute for Health Information, Hepatitis C was the cause of liver failure for 20 per cent of the liver transplant patients between 2005 and 2014.  In 2014, 537 liver transplants were performed in Canada, 27 per cent more than the
423 performed in 2005.  On December 31, 2014, 507 people were waiting for a liver transplant in Canada.  In 2014, a total of 119 patients died while waiting for liver transplantation.

In an article published in the “Canadian Journal of Gastroenterology and Hepatology” (May 2014) – Burden of Disease and Cost of Chronic Hepatitis C Virus Infection in Canada – researchers projected that Canada would experience a significant increase in cases of advanced HCV-related liver disease over the next 20 years (to 2035), as well as a dramatic increase in healthcare costs mainly attributable to cirrhosis and more advanced disease and their complications including liver cancer and liver transplantation.  The article estimated lifetime costs of HCV vary substantially according to disease state.  Specifically, lifetime cost for a patient requiring liver transplantation was $327,608 in 2013.  The authors said there was an urgent need to utilize new antiviral therapy to stem the imminent tide of HCV-related morbidity and mortality.

“As an immediate next step, we hope that broadening the sample size across Canada may establish the true impact of this strategy to not only save health care dollars, but, most importantly, to save lives without the need for liver transplantation,” added Dr. Marotta.

The “Analysis of Safety and Efficacy of Sofosbuvir-Based Therapy in Liver Transplant Assessed Hepatitis C Patients” data was recently presented at the Canadian Digestive Diseases Week meeting in Montreal.

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HCV in Canada

HCV is a liver disease caused by the hepatitis C virus that attacks the liver, and is spread through blood-to-blood contact.  According to the Canadian Liver Foundation, it is estimated that 250,000 Canadians are infected with HCV.  People with HCV often have no symptoms.  Many infected people live for up to 20 or 30 years without feeling sick.  When or if symptoms appear during the late stage of infection, they often reflect serious damage to the liver.

Note to Editor

Sofosbuvir-based treatments include sofosbuvir (Sovaldi®) or sofosbuvir/ledipasvir (Harvoni™).  Patients who achieve an SVR12 (sustained viral response at 12 weeks post treatment) are considered cured of HCV.

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