Evidence map›Paper›PMID 32843477›Full record

Trial reportJournal of the American Society of Nephrology : JASN2020

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 and 19 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04614142 (Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04614142 phase4withdrawnnot on this map

Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access

TypeinterventionalSponsorMassachusetts General HospitalRan2020 to 2021Enrolled0ConditionsEnd Stage Renal Disease, Chronic Hepatitis cArmsGlecaprevir / Pibrentasvir Oral Tablet [Mavyret]
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Review
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  8. Review
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  11. Twelve-month kidney and liver outcomes of kidney transplantation from Hepatitis C Viremic deceased donors to aviremic recipients.Transplant infectious disease : an official journal of the Transplantation Society · 2024
    Article
  12. Antiviral Treatment Failures After Transplantation of Organs From Donors With Hepatitis C Infection: A Report of 4 Cases.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2023
    Article
  13. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 11 institutions in 1 country.

Meghan E SiseDivision of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
David S GoldbergDivision of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida.ORCID 0000-0002-1465-0691
Jens J KortGlobal Medical Affairs Research and Development, AbbVie Inc., North Chicago, Illinois.
Douglas E SchaubelDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Rita R AllowayDivision of Nephrology, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Christine M DurandDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Robert J FontanaDivision of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan.
Robert S BrownDivision of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York.
John J FriedewaldComprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois.ORCID 0000-0002-9344-9928
Stacey PrennerDivision of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania.
J Richard LandisDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Melissa FernandoDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Caitlin C PhillipsDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0002-5020-914X
E Steve WoodleDivision of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Adele Rike-ShieldsDivision of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Kenneth E ShermanDivision of Digestive Disease, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Nahel EliasTransplant Center and Division of Transplant Surgery, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts.ORCID 0000-0001-6466-7347
Winfred W WilliamsDivision of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
Jenna L GustafsonGastrointestinal Division, Department of Medicine, Liver Center, Massachusetts General Hospital, Boston, Massachusetts.
Niraj M DesaiDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Brittany BarnabaDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Silas P NormanDivision of Nephrology, Michigan Medicine, Ann Arbor, Michigan.
Mona DoshiDivision of Nephrology, Michigan Medicine, Ann Arbor, Michigan.
Samuel T SultanDivision of Transplant Surgery, New York-Presbyterian/Weill Cornell Medicine, New York, New York.
Meredith J AullDivision of Transplant Surgery, New York-Presbyterian/Weill Cornell Medicine, New York, New York.
Josh LevitskyComprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Dianne S BelsheComprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Raymond T ChungGastrointestinal Division, Department of Medicine, Liver Center, Massachusetts General Hospital, Boston, Massachusetts Chung.Raymond@mgh.harvard.edu.ORCID 0000-0003-4835-9197
Peter P ReeseDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0003-1440-069X
University of Pennsylvania · USMassachusetts General Hospital · USCornell University · USJohns Hopkins University · USNorthwestern University · USUniversity of Cincinnati Medical Center · USMichigan Medicine · USAbbVie (United States) · USChrist Hospital · USUniversity of Miami · USUniversity of Michigan · US

Funding

Patient-Oriented Research on Hepatitis in Special PopulationsK24DK078772 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHUNG, RAYMOND T · 2007 to 2016
$1.6M
Effect of Hepatitis C Virus Eradication on Chronic Kidney Disease ProgressionK23DK117014 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI SISE, MEGHAN E. · 2018 to 2022
$865k
NIDDK NIH HHS K23 DK117014NIDDK NIH HHS K24 DK078772
6 · The paper itself

Abstract

backgroundSingle-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.

methodsWe 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.

resultsWe 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 m

conclusionsOur 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.

Indexed as

HepacivirusKidney TransplantationAdultAllograftsAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesDrug CombinationsFemaleGlomerular Filtration RateHepatitis CHumansKidneyLactams, MacrocyclicLeucineAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesDrug CombinationsglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesRNA, ViralSulfonamidesdirect-acting antiviralshepatitis C viruskidney transplantationorgan allocation

Identifiers

PMID32843477
PMCPMC7608971
OpenAlexW3080638426

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.