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Clinical Research
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Multicenter Study to Transplant Hepatitis C–Infected Kidneys (MYTHIC): An Open-Label Study of Combined Glecaprevir and Pibrentasvir to Treat Recipients of Transplanted Kidneys from Deceased Donors with Hepatitis C Virus Infection

Meghan E. Sise, David S. Goldberg, Jens J. Kort, Douglas E. Schaubel, Rita R. Alloway, Christine M. Durand, Robert J. Fontana, Robert S. Brown, John J. Friedewald, Stacey Prenner, J. Richard Landis, Melissa Fernando, Caitlin C. Phillips, E. Steve Woodle, Adele Rike-Shields, Kenneth E. Sherman, Nahel Elias, Winfred W. Williams, Jenna L. Gustafson, Niraj M. Desai, Brittany Barnaba, Silas P. Norman, Mona Doshi, Samuel T. Sultan, Meredith J. Aull, Josh Levitsky, Dianne S. Belshe, Raymond T. Chung and Peter P. Reese
JASN November 2020, 31 (11) 2678-2687; DOI: https://doi.org/10.1681/ASN.2020050686
Meghan E. Sise
1Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts
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David S. Goldberg
2Division of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida
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Jens J. Kort
3Global Medical Affairs Research and Development, AbbVie Inc., North Chicago, Illinois
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Douglas E. Schaubel
4Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
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Rita R. Alloway
5Division of Nephrology, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio
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Christine M. Durand
6Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
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Robert J. Fontana
7Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan
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Robert S. Brown Jr.
8Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York
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John J. Friedewald
9Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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  • ORCID record for John J. Friedewald
Stacey Prenner
10Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania
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J. Richard Landis
4Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
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Melissa Fernando
4Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
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Caitlin C. Phillips
4Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
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E. Steve Woodle
11Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio
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Adele Rike-Shields
11Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio
12The Christ Hospital, Cincinnati, Ohio
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Kenneth E. Sherman
13Division of Digestive Disease, University of Cincinnati College of Medicine, Cincinnati, Ohio
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Nahel Elias
14Transplant Center and Division of Transplant Surgery, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts
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  • ORCID record for Nahel Elias
Winfred W. Williams
1Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts
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Jenna L. Gustafson
15Gastrointestinal Division, Department of Medicine, Liver Center, Massachusetts General Hospital, Boston, Massachusetts
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Niraj M. Desai
16Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
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Brittany Barnaba
6Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
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Silas P. Norman
17Division of Nephrology, Michigan Medicine, Ann Arbor, Michigan
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Mona Doshi
17Division of Nephrology, Michigan Medicine, Ann Arbor, Michigan
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Samuel T. Sultan
18Division of Transplant Surgery, New York-Presbyterian/Weill Cornell Medicine, New York, New York
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Meredith J. Aull
18Division of Transplant Surgery, New York-Presbyterian/Weill Cornell Medicine, New York, New York
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Josh Levitsky
9Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois
19Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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Dianne S. Belshe
9Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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Raymond T. Chung
15Gastrointestinal Division, Department of Medicine, Liver Center, Massachusetts General Hospital, Boston, Massachusetts
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Peter P. Reese
4Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
20Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
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Significance Statement

Single-center trials and retrospective case series have reported promising outcomes transplanting kidneys from donors with hepatitis C virus (HCV) infection into HCV-negative recipients, although concerns remain about immunologic complications. In this first multicenter trial, 30 HCV-uninfected adults received a kidney from an HCV-viremic deceased donor and were cured of HCV with an 8-week regimen of coformulated glecaprevir and pibrentasvir initiated 2–5 days post-transplant. Three patients developed acute cellular rejection and three developed BK viremia near or >10,000 copies/ml that resolved after immunosupression reduction; none experienced severe adverse events associated with the antiviral treatment or HCV. Overall allograft function at 6 months was excellent. These findings demonstrate that HCV-viremic kidneys offer a valuable resource for transplantation and that donor-derived HCV can be effectively managed with early antiviral treatment.

Abstract

Background Single-center trials and retrospective case series have reported promising outcomes using kidneys from donors with hepatitis C virus (HCV) infection. However, multicenter trials are needed to determine if those findings are generalizable.

Methods We conducted a prospective trial at seven centers to transplant 30 kidneys from deceased donors with HCV viremia into HCV-uninfected recipients, followed by 8 weeks of once-daily coformulated glecaprevir and pibrentasvir, targeted to start 3 days posttransplant. Key outcomes included sustained virologic response (undetectable HCV RNA 12 weeks after completing treatment with glecaprevir and pibrentasvir), adverse events, and allograft function.

Results We screened 76 patients and enrolled 63 patients, of whom 30 underwent kidney transplantation from an HCV-viremic deceased donor (median kidney donor profile index, 53%) in May 2019 through October 2019. The median time between consent and transplantation of a kidney from an HCV-viremic donor was 6.3 weeks. All 30 recipients achieved a sustained virologic response. One recipient died of complications of sepsis 4 months after achieving a sustained virologic response. No severe adverse events in any patient were deemed likely related to HCV infection or treatment with glecaprevir and pibrentasvir. Three recipients developed acute cellular rejection, which was borderline in one case. Three recipients developed polyomavirus (BK) viremia near or >10,000 copies/ml that resolved after reduction of immunosuppression. All recipients had good allograft function, with a median creatinine of 1.2 mg/dl and median eGFR of 57 ml/min per 1.73 m2 at 6 months.

Conclusions Our multicenter trial demonstrated safety and efficacy of transplantation of 30 HCV-viremic kidneys into HCV-negative recipients, followed by early initiation of an 8-week regimen of glecaprevir and pibrentasvir.

  • hepatitis C virus
  • kidney transplantation
  • direct-acting antivirals
  • organ allocation
  • Copyright © 2020 by the American Society of Nephrology
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Journal of the American Society of Nephrology: 31 (11)
Journal of the American Society of Nephrology
Vol. 31, Issue 11
November 2020
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Multicenter Study to Transplant Hepatitis C–Infected Kidneys (MYTHIC): An Open-Label Study of Combined Glecaprevir and Pibrentasvir to Treat Recipients of Transplanted Kidneys from Deceased Donors with Hepatitis C Virus Infection
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Multicenter Study to Transplant Hepatitis C–Infected Kidneys (MYTHIC): An Open-Label Study of Combined Glecaprevir and Pibrentasvir to Treat Recipients of Transplanted Kidneys from Deceased Donors with Hepatitis C Virus Infection
Meghan E. Sise, David S. Goldberg, Jens J. Kort, Douglas E. Schaubel, Rita R. Alloway, Christine M. Durand, Robert J. Fontana, Robert S. Brown, John J. Friedewald, Stacey Prenner, J. Richard Landis, Melissa Fernando, Caitlin C. Phillips, E. Steve Woodle, Adele Rike-Shields, Kenneth E. Sherman, Nahel Elias, Winfred W. Williams, Jenna L. Gustafson, Niraj M. Desai, Brittany Barnaba, Silas P. Norman, Mona Doshi, Samuel T. Sultan, Meredith J. Aull, Josh Levitsky, Dianne S. Belshe, Raymond T. Chung, Peter P. Reese
JASN Nov 2020, 31 (11) 2678-2687; DOI: 10.1681/ASN.2020050686

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Multicenter Study to Transplant Hepatitis C–Infected Kidneys (MYTHIC): An Open-Label Study of Combined Glecaprevir and Pibrentasvir to Treat Recipients of Transplanted Kidneys from Deceased Donors with Hepatitis C Virus Infection
Meghan E. Sise, David S. Goldberg, Jens J. Kort, Douglas E. Schaubel, Rita R. Alloway, Christine M. Durand, Robert J. Fontana, Robert S. Brown, John J. Friedewald, Stacey Prenner, J. Richard Landis, Melissa Fernando, Caitlin C. Phillips, E. Steve Woodle, Adele Rike-Shields, Kenneth E. Sherman, Nahel Elias, Winfred W. Williams, Jenna L. Gustafson, Niraj M. Desai, Brittany Barnaba, Silas P. Norman, Mona Doshi, Samuel T. Sultan, Meredith J. Aull, Josh Levitsky, Dianne S. Belshe, Raymond T. Chung, Peter P. Reese
JASN Nov 2020, 31 (11) 2678-2687; DOI: 10.1681/ASN.2020050686
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