One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial
Meghan Elizabeth Sise, David Seth Goldberg, Douglas Earl Schaubel, Robert J Fontana, Jens J Kort, Rita R Alloway, Christine M Durand, Emily A Blumberg, E Steve Woodle, Kenneth E Sherman, Robert S Brown Jr, John J Friedewald, Niraj M Desai, Samuel T Sultan, Josh Levitsky, Meghan D Lee, Ian A Strohbehn, J Richard Landis, Melissa Fernando, Jenna L Gustafson, Raymond T Chung, Peter Philip Reese, Meghan Elizabeth Sise, David Seth Goldberg, Douglas Earl Schaubel, Robert J Fontana, Jens J Kort, Rita R Alloway, Christine M Durand, Emily A Blumberg, E Steve Woodle, Kenneth E Sherman, Robert S Brown Jr, John J Friedewald, Niraj M Desai, Samuel T Sultan, Josh Levitsky, Meghan D Lee, Ian A Strohbehn, J Richard Landis, Melissa Fernando, Jenna L Gustafson, Raymond T Chung, Peter Philip Reese
Abstract
Introduction: Transplanting kidneys from hepatitis C virus (HCV) viremic donors into HCV-negative patients (HCV D-RNA-positive/R-negative) has evolved from experimental to "standard-of-care" at many centers. Nevertheless, most data derive from single centers and provide only short-term follow-up.
Methods: The Multicenter Study to Transplant Hepatitis C-Infected Kidneys (MYTHIC) study was a multicenter (7 sites) trial of HCV D-RNA-positive/R-negative kidney transplantation (KT) followed by 8 weeks of glecaprevir/pibrentasvir (G/P) initiated 2 to 5 days post-KT. Prespecified outcomes included probability of KT (vs. matched waitlist comparators) and 1-year safety outcomes, allograft function, and survival.
Results: Among 63 enrolled patients, 1-year cumulative incidence of KT was approximately 3.5-fold greater for the MYTHIC cohort versus 2055 matched United Network for Organ Sharing (UNOS) comparators who did not opt-in to receive a kidney from an HCV-viremic donor (68% vs. 19%, P < 0.0001). Of 30 HCV D-RNA-positive/R-negative KT recipients, all achieved HCV cure. None developed clinically significant liver disease or HCV-related kidney injury. Furthermore, 1-year survival was 93% and 1-year graft function was excellent (median creatinine 1.17; interquartile range [IQR]: 1.02-1.38 mg/dl). There were 4 cases of cytomegalovirus (CMV) disease among 10 CMV-negative patients transplanted with a kidney from an HCV-viremic/CMV-positive donor.
Conclusion: The 1-year findings from this multicenter trial suggest that opting-in for HCV-viremic KT offers can increase probability of KT with excellent 1-year outcomes. Trial Registration: NCT03781726.
Keywords: cytomegalovirus infection; direct-acting antivirals; glecaprevir/pibrentasvir; hepatitis C virus; kidney transplantation; organ allocation.
© 2021 International Society of Nephrology. Published by Elsevier Inc.
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Source: PubMed