Hepatitis C virus-negative candidates who receive transplants with HCV-infected hearts experience acceptable outcomes and high cure rates, according to recently published study findings.
“The study was prompted by our deep concern that the lack of organs for transplantation puts a tremendous burden on patients with advanced heart disease. The opiate crisis has driven a large spike in the number of individuals who die from a drug overdose and with hepatitis C virus infection,” Peter P. Reese, MD, MSCE, associate professor of medicine at Perelman School of Medicine at the University of Pennsylvania, told Infectious Disease News.
“Many of their loved ones take interest in organ donation as a part of their grieving process. However, historically, hearts from donors with hepatitis C virus were almost always discarded because the treatment options had terrible side effects. Our team recognized that new treatments for hepatitis C could create a major opportunity to make many more organs available for transplant and benefit a large number of patients.”
To determine the safety and efficacy of transplanting hearts from HCV-infected donors into HCV-negative patients, Reese and colleagues enrolled candidates aged 40 to 65 years in USHER, a single-arm trial of orthotopic heart transplantation (OHT) from infected donors to uninfected recipients. From May 16, 2017, through April 10, 2018, 10 patients were screened, enrolled and received hearts from HCV-genotype 1 donors. Recipients were treated with elbasvir/grazoprevir once HCV was detected.
According to the study, initial recipient HCV RNA levels ranged from 25 IU/mL to 40 million IU/mL, but all 10 patients had rapid decline in HCV nucleic acid testing after DAA treatment, Reese and colleagues explained. According to the researchers, nine recipients achieved SVR for 12 or more weeks at the end of the study period. The 10th recipient, however, had a positive cross-match, experienced antibody-mediated rejection and multiorgan failure and died on day 79, they reported.
According to Reese and colleagues, no serious adverse events occurred from HCV transmission or treatment and the results suggest that HCV-negative candidates who received transplants with HCV-infected hearts have acceptable outcomes.
“USHER is the first registered, prospective clinical trial of using hepatitis C virus-infected hearts in uninfected recipients. The USHER trial brings another valuable piece of evidence that direct-acting antiviral drugs for hepatitis C can cure the infection at a high rate, even in patients with substantial immunosuppression from transplant medications,” Reese said. “Hearts donated by individuals with hepatitis C virus infection are a precious resource. The transplant community should take steps to maximize the use of these organs in well-informed patients.” – by Caitlyn Stulpin
Disclosures: Reese reports receiving investigator-initiated support from Merck and CVS, being an associate editor for the American Journal of Kidney Diseases and being a consultant for COHRDATA. Please see the study for all other authors’ relevant financial disclosures.