Baylor Scott & White Research Institute today announced the start of a new clinical trial designed to address the viability of using hepatitis C-positive donor hearts for transplantation.
The study will investigate the effectiveness of using donated hepatitis C-positive hearts in heart (thoracic) transplantation of patients who do not carry the hepatitis C virus. Should the heart transplant patient show signs of contracting hepatitis C following transplantation, the team will implement antiviral therapy within 14 days of quantifiable viremia (infection). The medication regime is the Food and Drug Administration-approved, newer, well-tolerated, oral direct-antivirals (DAA).
A paper published online April 10 in Current Transplant Reports looks a potential use of hepatitis C-positive hearts in thoracic transplants. Hepatitis C is a liver disease that is caused by infection with the hepatitis C virus, a virus that lives in the liver cells. It is curable in most cases by antiviral therapy.
The investigator-initiated trial, called "Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis C Heart Recipients (TROJAN-C)" is a multi-center consortium trial, designed and led by Shelley Hall, MD, and Robert Gottlieb, MD, Ph.D., Baylor University Medical Center at Dallas. Joining the study are Cedars Sinai Medical Center in Los Angeles and Duke University Medical Center in Durham, N.C. Baylor Scott & White Research Institute is administering the trial.
This potentially could be a step in reducing chronic shortage of donor hearts for heart transplantation in adult patients. On any given day, there are nearly 4,000 people in the United States who are on the waitlist for a heart, according to Donate Life website.
The Journal of Cardiac Failure (Vol. 23, No. 10 2017) published a brief report of the pilot study to this program, "Rational Heart Transplant From a Hepatitis C Donor: New Antiviral Weapons Conquer the Trojan Horse," also by Drs. Hall and Gottlieb last year. The pilot study reports the successful use of a pangenotypic antiviral agent after donor-derived acute hepatitis C infection was transmitted into a cardiac transplant patient without the hepatitis C virus. Adult patients who did not qualify for bridging mechanical support therapy accepted a heart transplant offer from a donor with the hepatitis C virus. Prompt resolution of the infection was noted by the first week of a 12-week course of antiviral therapy, followed by sustained remission.
The study's investigators state that organs from donors with active hepatitis C infection likely are suitable for transplant if the organ is otherwise acceptable. Best practices for "informed-risk" transplant include a team-based approach and a selection of the antiviral regimen based on insurer's formulary, potential drug interactions and genotype. Expansion of the thoracic donor pool to include hearts from hepatitis C-positive donors holds promise to increase available donor organs.
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