Outcomes of Adult Heart Transplantation Using Hepatitis C–Positive Donors

Abstract

Background This study evaluated the impact of hepatitis C–positive ( HCV +) donors on outcomes of heart transplantation in the United States. Methods and Results Adults undergoing isolated heart transplantation in the United States between January 1, 2016, and December 31, 2018, were included. The primary outcome was 1‐year post‐transplant survival. Multivariable Cox regression and 2:1 propensity matching were used to compare outcomes between transplants with HCV + and hepatitis C–negative ( HCV −) donors. A subanalysis was performed to evaluate the impact of nucleic acid amplification test positivity on outcomes. Of 7889 isolated heart transplants performed during the study period, 343 (4.4%) used HCV + donors. Overall unadjusted 1‐year posttransplant survival was not statistically different between HCV − versus HCV + donors (91.1% versus 90.2%; P =0.86), a finding that persisted after risk adjustment (hazard ratio, 1.05; 95% CI, 0.70–1.58; P =0.80). Propensity matching resulted in 675 well‐balanced patients (437 HCV − and 238 HCV +). Overall 1‐year posttransplant survival was not statistically different in propensity‐matched analysis (89.8% HCV − versus 89.2% HCV +; P =0.88). Rates of 1‐year drug‐treated rejection (21.1% versus 22.1%; P =0.84), postoperative dialysis (11.4% versus 14.7%; P =0.22), and stroke (4.6% versus 2.1%; P =0.10) were also not statistically different between HCV − and HCV + groups, respectively. Outcomes were not statistically different between nucleic acid amplification test–negative and nucleic acid amplification test–positive HCV + donors. Conclusions Adult heart transplants using HCV + donors, including those that are nucleic acid amplification test positive, can be performed without an adverse impact on 1‐year survival. Wider implementation of protocols for using HCV + donors and an assessment of longer‐term outcomes including seroconversion rates will be important in maximizing the effect of HCV + donors on national donor shortages.

Outcomes of the Treatment with Glecaprevir/Pibrentasvir following heart transplantation utilizing hepatitis C viremic donors

“…The increased interest in the utilization of hepatitis C‐positive (HCV) organs has continued to grow with other medical centers demonstrating successful outcomes 1,2 . These trials, with detailed oversight and management, have cautiously advocated the use of viremic donors to address the worldwide shortage of eligible matching donors which persists in the modern era 3 .…”

Cost-effectiveness of using hepatitis C viremic hearts for transplantation into HCV-negative recipients

“…Third, we assumed in our baseline model that patients who received an HCV‐viremic heart and then successfully achieved SVR would have no negative consequences on further health outcomes. Thus far in early trials, there have been no reports of increased rates of rejection, increased infectious complications, or increased mortality among those receiving HCV‐viremic organs 20‐24,68‐76 . However, these outcomes are early and so in our sensitivity analysis we incrementally increased both costs and mortality to account for this possibility, finding that willingness to accept a heart was cost effective provided it is not associated with a relative increase of more than 7% posttransplant mortality compared to those receiving HCV‐negative hearts.…”

“…We examined the impact of variations in HCV prevalence among organ donors (2.5% or 10% compared to 4.9% at baseline), DAA SVR (90% compared to 95%), and DAA cost ($13 000, $24 000, and $80 000 compared to $39 600), and baseline cohort age (40‐65 years, compared to 50 at baseline). Although early data have not demonstrated significant differences in mortality, graft function, or rejection among recipients of HCV‐viremic compared to HCV‐negative organs, 20‐24,68‐76 we additionally performed a sensitivity analysis to evaluate the potential for negative outcomes in patients receiving hearts from HCV‐viremic donors by incrementally varying the posttransplant mortality and costs in this group by a relative 1%‐10% compared to those receiving HCV‐negative hearts. Finally, we undertook a probabilistic sensitivity analysis where we varied all model input parameters simultaneously using 10 000 simulations to determine uncertainty in the ICER (sampling distributions in Table 1), plotting the proportion of simulations which fell under various WTP thresholds.…”

Hepatitis C viraemic organs in solid organ transplantation

“…While it was important consideration historically, genotype competition is less of an issue now that pan-genotype DAAs are widely available. Further, preliminary data suggests that patients previously treated for HCV have had successful re-treatment of HCV reinfection and can be managed the same as HCV-naïve patients 20,22,61 . Our practice is to genotype patients post-transplant and treat accordingly.…”