HCV-Positive Hearts Could Increase Donor Pools

December 24, 2019
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

With a shortage of hearts available, investigators turn to HCV-positive donors to try to reduce wait times.

Kelly H. Schlendorf, MD

Using hearts from hepatitis C virus (HCV) positive donors could dramatically increase the donor pool, while shortening wait times, and decreasing wait-list mortality.

A team, led by Kelly H. Schlendorf, MD, Vanderbilt University Medical Center, recently sought to better define the link between hepatitis C-positive donors with heart transplant volumes, wait-list duration, the transmission and cure of donor-derived hepatitis C, and the morbidity and mortality at 1 year in a prospective, single-center, observational study.

The investigators examined 80 adult patients who recently underwent heart transplants using hearts from hepatitis C-positive donors. The median wait-list time for the participants was 4 days and donor-derived hepatitis C infections were easily curable using direct-acting antivirals despite immunosuppression.

The 1-year survival, which exceeded 90%, was not significantly different when compared to the survival rate of patients who were transplanted with hearts from hepatitis C-negative donors during the same time period.

“Using hepatitis C—positive donors may afford a strategy to substantially expand the donor pool for patients awaiting heart transplant, increasing transplant volumes, and reducing morbidity and mortality on the wait-list,” the authors wrote.

Each patient in the study underwent a heart transplant between Sept. 2016 and April 2019 and a large academic medical center. A HCV-positive donor was defined as a donor with a positive HCV antibody or HCV nucleic acid testing.

Transplant recipients were given an initial regimen of mycophenolate mofetil (1g every 12 hours), tacrolimus (titrated to a trough level of 8-12 ng/mL), and a steroid taper. Patients underwent surveillance endomyocardial biopsies, as well as a coronary angiography at 1 year following the transplant.

Of the hepatitis C positive donors, 70 had viremia and 10 were seropositive, but did not have viremia.

None of the recipients of donors with negative nucleic acid testing results (n=10) developed donor-derived hepatitis C. For the 70 patients who received hearts with positive nucleic acid testing results, 67 (95.7%) developed donor-derived hepatitis C over a median follow-up of 301 days.

However, treatment with direct-acting antivirals was generally well tolerated, yielding sustained virologic responses in all of the treated patients.

There is currently a shortage of donor hearts, contributing to prolonged wait times, increased reliance on mechanical circulator support, and higher mortality rates.

During the most recent era, median wait times ranged from 7-535 days, depending on blood type. In 2018, more than 950 patients died waiting for a transplant or were removed from the wait-list due to a progressive illness.

Previously, investigators found poor outcomes and high infection rates in recipients using HCV-positive donors.

However, direct-acting antivirals have yielded a high HCV cure rate, breathing new life into the concept of using organs from HCV-positive donors to expand the donor pool.

Earlier this year, investigators from the University of Tennessee’s Health Science Center, found that HCV-infected kidneys could be safely transplanted into HCV-negative recipients.

In the study, all 53 recipients became viremic, 34 of which became viremic with genotype 1a, while 1 participant became viremic with genotype 1b, 3 with genotype 2, and 15 with genotype 3.

Approximately 81% of the recipients did not experience clinically significant increases, which were more than 3 times higher than the upper limit of the normal value in aminotransferase levels, with their HCV RNA levels in the 5-6 log range.

Only 1 patient developed fibrosing cholestatic hepatitis with complete resolution, while all recipients completed antiviral treatment, 100% of which were HCV RNA-negative and achieved 12-week sustained virologic response.

The study, “Expanding Heart Transplant in the Era of Direct-Acting Antiviral Therapy for Hepatitis C,” was published online in JAMA Cardiology.