Hope for Patients Awaiting Organ Transplants
A successful clinical trial completed at Brigham and Women’s Hospital offers hope for the 110,000 patients currently waiting for heart, lung, kidney, or liver transplant. The providers are working diligently to bring them suitable organs.
The first phase of the DONATE HCV Trial enrolled 44 patients who had received a heart or lung transplant from donors who were infected with hepatitis C virus (HCV). The trial demonstrated that thoracic organs could be safely transplanted from HCV-infected donors by treating with a shortened four-week antiviral regimen begun within hours of the transplant surgery.
All transplant recipients achieved the study’s primary endpoint: an undetectable HCV viral load and 6-month survival.
This trial paves the way toward substantially expanding the pool of donor organs. Given its successful outcomes, the trial is ongoing. As of February 2020, more than 80 transplants have been performed at Brigham and Women’s Hospital from HCV-infected thoracic donors.
This is the largest clinical trial to date for HCV thoracic organ transplantation, noted Ann Woolley, MD, Transplant Infectious Disease physician and corresponding author of the study, published in The New England Journal of Medicine. It provides clear evidence that this shortened antiviral regimen, initiated within hours of transplant, can prevent the establishment of HCV and lead to excellent outcomes for recipient patients.
There were no HCV-associated adverse events. The study protocol is now being adopted by other centers nationally and internationally and could inform the expansion of available HCV-positive organs to kidneys and livers, as well.
“HCV infection has been a long-standing reason to decline donation of suitable organs,” said co-author Lindsey Baden, MD, director of Clinical Research in the Division of Infectious Diseases at the Brigham. “I am very encouraged by the results of this study, which may allow us to provide transplantation successfully to the many recipients who might otherwise never have access to it.”