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Lungs from donors who had hepatitis C have been successfully transplanted into 10 patients at Toronto General Hospital (TG).
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) allows doctors to assess organs outside of the body and predict how well they 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 today in Toronto.
"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 over 240 patients waiting for a lung transplant in Canada alone and it's estimated that 20 per cent of patients die while waiting for lungs to become available.