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Toronto (June 14, 2018) – Donor lungs from individuals infected with hepatitis C have been successfully transplanted into 10 patients at Toronto General Hospital (TG), University Health Network (UHN).
All patients have recovered from their transplant surgery. Eight of them have already tested negative for the virus and the last two patients have recently started taking the drug regimen.
The transplants are part of a clinical trial that is the first to assess the safety of transplanting hepatitis positive organs to non-infected patients using the
ex vivo technology. Developed at TG in 2008, the Toronto Ex Vivo Lung Perfusion System (EVLP) perfuses organs outside of the body, allowing doctors to assess the organ and predict how well it will do before transplantation.
The use of hepatitis C infected organs to help deal with the shortage in organ donors will be discussed by experts at the Global Hepatitis Summit, which starts in Toronto on June 14.
"With the opioids crisis and persistent high rates of intravenous drug use, we have a great number of potential lung donors who are hepatitis C positive – many of whom didn't even know they were sick when they were alive," says Dr. Marcelo Cypel, thoracic surgeon at TG, UHN, scientist at Toronto General Hospital Research Institute (TGRI) and principal investigator in the study.
"The current protocol is to not use these organs, but we started to question if that still made sense in an era when direct anti-viral agents (DAAs) can cure hepatitis C," he says.
The study is led by Drs. Cypel, Atul Humar, Medical Director of UHN Transplant, and Jordan Feld, specialist from the Toronto Centre for Liver Disease, TG, UHN.
In recent years, the latest drug regimen of sofosbuvir-velpatasvir for a 12-week period has been used to cure patients with hepatitis C around the world. However, there were still concerns around how this could impact transplants.
The questions researchers want to answer are: if hepatitis C negative patients can be safely transplanted with infected donor organs, and whether they can clear the virus after their surgery.
For this study, lungs were placed in the EVLP circuit in a sterile dome for six hours. The surgical team was able to evaluate the lung function and be certain that the organs were suitable for transplant, despite being infected with hepatitis C.
After six hours, EVLP reduced the hepatitis C virus count to very low levels. As expected, patients still contracted the disease. However, they tested negative for hepatitis within only three weeks of treatment with DAAs, in average.
"This is an initial study, but it shows positive results," says Dr. Feld. "It suggests that it is safe to use these organs which otherwise we could not have used. This could eventually be a big boost for organ donation."
"We have a long standing tradition of excellence and pushing boundaries in transplant research and we are pleased that we were able to pioneer this study," Dr. Humar says.
Dr. Cypel estimates that accepting hepatitis C positive donors would increase the number of lungs available for transplant by 1,000 per year in North America. Currently, approximately 2,600 lung transplants are done per year in Canada and the United States combined.
As of 2016, there were more than 240 patients waiting for a lung transplant in Canada alone and the estimate is that 20 per cent of patients die while waiting for lungs to become available.
As important as the fight against the virus, is the fight against stigma. As studies start to show that it is safe to transplant organs from hepatitis C positive donors, doctors are educating patients about the disease and on how effective DAAs are in curing it.
Stanley De Freitas, 73, is one of the patients who received lungs as part of the study. He suffered from pulmonary fibrosis and agreed to receive hepatitis positive lungs in October, 2017.
"People take breathing for granted and don't realize the limitations of having a pulmonary disease," says De Freitas.
"Now, every breath I take I think of my donor and it doesn't matter that the donor had hepatitis C. I didn't even have any symptoms of the disease. I recovered well and now I can enjoy life with my two daughters, four grandchildren and my two great-grandchildren."
De Freitas says at first he was worried about contracting hepatitis C, but after receiving information about the disease, he didn't think twice and gladly accepted the life-saving lung transplant. He urges other patients to do the same.
"If these lungs or other organs are available, go for it! The treatment is effective and you will have your life back."
Eva Runciman, 52, suffered from Chronic Obstructive Pulmonary Disease (COPD). Before her transplant, in February, she couldn't walk because she had difficulty breathing.
"I would tell everyone waiting for a transplant not to be afraid of accepting organs with hepatitis C, trust the treatment," she says. "The change in life quality is just amazing. I now can walk, I can drive and play with my grandkids."
About the clinical trial
The first phase of the study was comprised of the 10 surgeries - performed between October, 2017 and May, 2018. The average age of the organ donors was 33 and the average age of the recipients was 64. The study will be followed by a second phase that will further assess techniques to use organs carrying the virus.
This work is supported by the Canadian Institutes of Health Research, Medicine by Design, Toronto General & Western Hospital Foundation, Gilead Sciences and Xvivo Perfusion. Dr. Cypel also praised the efforts and support of Trillium Gift of Life, which co-ordinates organ and tissue donation across Ontario and without whom this trial would not have been possible.
"We are very grateful to our donors and to Trillium for coordinating the organ donor lists and making it possible for us to conduct this study."
The Global Hepatitis Summit, 2018 is being held at Metro Toronto Convention Centre from June 14 to 17.
"The advent of DAAs has really created a dramatic shift in how we treat hepatitis C. This study is a perfect example of the latest developments in this exciting rapidly moving field that we will be discussing during this week's Global Hepatitis Summit," says Dr. Feld.
The summit will bring together top clinicians and researchers from around the world to Toronto to discuss the remarkable therapeutic developments in recent years and the prospect of disease elimination. The Global Hepatitis Summit 2018 is chaired by UHN's physicians and researchers Drs. Harry Janssen, Jordan Feld and Adam Gehring. More information is available on the
Global Hepatitis Summit's website.
Photos and B-roll:
To download video and photos of the EVLP circuit and one of the hepatitis C positive lungs transplant that was part of the study, please visit:
Credit: "Courtesy UHN"
Dr. Marcelo Cypel has received research support from Xvivo Perfusion. Dr. Cypel is a shareholder of XOR labs Toronto and a consultant for lung bioengineering. Drs. Jordan Feld and Harry Janssen have received research support from pharmaceutical companies related to hepatitis C therapeutics.
Toronto General Hospital is a partner in University Health Network, along with Toronto Western, the Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The scope of research and complexity of cases at Toronto General Hospital have made it a national and international source for discovery, education and patient care. It has one of the largest hospital-based research programs in Canada, with major research in transplantation, surgical innovation, cardiology, infectious diseases, genomic medicine and liver disease. Toronto General Hospital is a research and teaching hospital affiliated with the University of Toronto.
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