One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial
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. Me...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-02-01
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| Series: | Kidney International Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S246802492101545X |
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| author | 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 |
| author_facet | 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 |
| author_sort | Meghan Elizabeth Sise |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-19T11:59:56Z |
| format | Article |
| id | doaj.art-b7e97dd8d0c64e328e842013af21b456 |
| institution | Directory Open Access Journal |
| issn | 2468-0249 |
| language | English |
| last_indexed | 2024-12-19T11:59:56Z |
| publishDate | 2022-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj.art-b7e97dd8d0c64e328e842013af21b4562022-12-21T20:22:32ZengElsevierKidney International Reports2468-02492022-02-0172241250One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) TrialMeghan Elizabeth Sise0David Seth Goldberg1Douglas Earl Schaubel2Robert J. Fontana3Jens J. Kort4Rita R. Alloway5Christine M. Durand6Emily A. Blumberg7E. Steve Woodle8Kenneth E. Sherman9Robert S. Brown, Jr.10John J. Friedewald11Niraj M. Desai12Samuel T. Sultan13Josh Levitsky14Meghan D. Lee15Ian A. Strohbehn16J. Richard Landis17Melissa Fernando18Jenna L. Gustafson19Raymond T. Chung20Peter Philip Reese21Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USADivision of Digestive Health & Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USADepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USADivision of Gastroenterology & Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USAGlobal Medical Affairs Research & Development, AbbVie Inc., North Chicago, Illinois, USADivision of Nephrology, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio, USADepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USADivision of Infectious Diseases, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USADivision of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio, USADivision of Digestive Disease, University of Cincinnati College of Medicine, Cincinnati, Ohio, USADivision of Gastroenterology & Hepatology, Weill Cornell Medicine, New York, New York, USAComprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USADepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USADivision of Transplant Surgery, New York-Presbyterian/Weill Cornell Medicine, New York, New York, USADivision of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USADepartment of Medicine, Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston, Massachusetts, USADivision of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USADepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USADepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USADepartment of Medicine, Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston, Massachusetts, USADepartment of Medicine, Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston, Massachusetts, USA; Correspondence: Raymond T. Chung, Liver Center, GI Division, Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 02114-2696, USA.Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA; Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA; Peter Reese, Department of Biostatistics, Epidemiology & Informatics, 917 Blockley Hall, 423 Guardian Drive, Philadelphia, Pennsylvania 19104, USA.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: NCT03781726http://www.sciencedirect.com/science/article/pii/S246802492101545Xcytomegalovirus infectiondirect-acting antiviralsglecaprevir/pibrentasvirhepatitis C viruskidney transplantationorgan allocation |
| spellingShingle | 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 One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial Kidney International Reports cytomegalovirus infection direct-acting antivirals glecaprevir/pibrentasvir hepatitis C virus kidney transplantation organ allocation |
| title | One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial |
| title_full | One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial |
| title_fullStr | One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial |
| title_full_unstemmed | One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial |
| title_short | One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial |
| title_sort | one year outcomes of the multi center study to transplant hepatitis c infected kidneys mythic trial |
| topic | cytomegalovirus infection direct-acting antivirals glecaprevir/pibrentasvir hepatitis C virus kidney transplantation organ allocation |
| url | http://www.sciencedirect.com/science/article/pii/S246802492101545X |
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