Piedmont Transplant Institute, which is based at Piedmont Atlanta Hospital, is one of only six sites in the U.S. for the potentially ground-breaking Pro-Act Study.
The study has been made possible by pharmacological advances that have achieved cure rates of greater than 95-percent for the Hepatitis C virus (HCV). In the study, patients who do not have HCV and are on the waiting list for either kidney or liver transplants receive organs from donors who are HCV-positive. Those patients are then treated for HCV shortly after transplant to try to prevent the complications associated with Hepatitis C.
For patients in need of a liver transplant who are officially on the wait list, nearly one in five die before an organ becomes available. For patients listed for a kidney transplant, the waiting times in Georgia average seven to nine years. The aims of the study are to show that receiving a HCV-positive organ is safe, that the Hepatitis C can be cured and that patients receiving an organ from a HCV-positive donor wait a shorter length of time than they would have had to wait otherwise.
The goal is to create a larger potential pool of organs for those in desperate need – a development that could prove to be life-saving.
The study, the formal name of which is “Prevention of De Novo HCV with Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant,” is being run out of the University of California-San Francisco. Piedmont Transplant Institute is the data-monitoring site for the study. Raymond A. Rubin, M.D., chief scientific officer and transplant hepatologist at Piedmont Transplant Institute, wrote the study’s protocol.
“In the world of transplant medicine, demand always exceeds supply in terms of donor organs,” Dr. Rubin said. “If this study is successful, it has the potential to save an untold number of lives for those sick patients awaiting transplant.”
Piedmont Transplant Institute did the first liver transplant in the country as part of this study in July. This patient has already completed his HCV treatment and has been cured of the virus. Piedmont did its first kidney transplant in the study in October. Overall, the study expects to enroll 30 liver and/or kidney transplant recipients across the country. Its estimated completion date is January 2021.
Patients will receive medications to cure them of Hepatitis C for 12 weeks and then doctors will monitor them for 24 additional weeks after the treatment is complete.
Hepatitis C is a viral infection that causes inflammation of the liver, which can lead to serious damage of the organ. HCV complications include cirrhosis, or scarring of the liver, liver cancer and liver failure.
For more information, visit https://clinicaltrials.gov/ct2/show/NCT03619837?term=rubin&cond=Hepatitis+C&rank=1.