Atlanta (March 6, 2020) – Piedmont Transplant Institute, which is based at Piedmont Atlanta Hospital, enrolled more patients in the potentially ground-breaking Pro-Act clinical trial than any other participating site in the United States. The study (officially titled, “Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant”) has reached its enrollment targets, with Piedmont placing nine of the 24 patients in the study (38 percent), according to Raymond Rubin, M.D., chief scientific officer and transplant hepatologist at Piedmont Transplant Institute.
Preliminary data from the study will be presented at the European Association for the Study of Liver Disease, which meets in London from April 15 to 19, and at the American Transplant Congress, which meets in Philadelphia in June. Piedmont Transplant Institute is the data-monitoring site for the study.
From July 1, 2018, through June 30, 2019 (Piedmont’s 2019 fiscal year), Piedmont transplanted 127 livers. Piedmont ranks in the top 10 percent of the country in abdominal organ transplant volumes and Piedmont Atlanta ranks among the nation’s busiest non-academic transplant hospitals.
“Piedmont’s involvement in this study and others like it, combined with our significant transplant volumes, demonstrates that we are a leader in this highly complex and important area of medicine,” said Dr. Rubin, who wrote the study’s protocol and is national co-lead investigator on the study. “We possess great talent at Piedmont Transplant and our achievements in this study are a testament to that.
“If this study is successful, it has the potential to save an untold number of lives for those sick patients awaiting transplant.”
The trial studies patients who do not have the Hepatitis C virus (HCV) and are then transplanted with 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. The study has been made possible by pharmacological advances that have achieved cure rates of greater than 95 percent for Hepatitis C virus (HCV).
For patients in need of a liver transplant who are officially on the wait list, nearly 1 in 5 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 is being run out of the University of California-San Francisco.
Piedmont Transplant Institute did the first liver transplant in the country as part of this study in July 2018. 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 2018.
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, please visit https://clinicaltrials.gov/ct2/show/NCT03619837?term=rubin&cond=Hepatitis+C&rank=1.