The SHELTER Trial of Transplanting Hepatitis C Virus-Infected Lungs Into Uninfected Recipients.


Journal

Transplantation direct
ISSN: 2373-8731
Titre abrégé: Transplant Direct
Pays: United States
ID NLM: 101651609

Informations de publication

Date de publication:
Jul 2023
Historique:
received: 23 11 2022
revised: 11 04 2023
accepted: 05 05 2023
medline: 30 6 2023
pubmed: 30 6 2023
entrez: 30 6 2023
Statut: epublish

Résumé

SHELTER is a trial of transplanting lungs from deceased donors with hepatitis C virus (HCV) infection into HCV-negative candidates (sponsor: Merck; NCT03724149). Few trials have reported outcomes using thoracic organs from HCV-RNA This study is a single-arm trial of 10 lung transplants at a single center. Patients were included who were between 18 and 67 y of age and waitlisted for lung-only transplant. Patients were excluded who had evidence of liver disease. Primary outcome was HCV cure (sustained virologic response 12 wk after completing antiviral therapy). Recipients longitudinally reported QOL using the validated RAND-36 instrument. We also applied advanced methods to match HCV-RNA Between November 2018 and November 2020, 18 patients were consented and opted-in for HCV-RNA SHELTER adds important evidence regarding the safety of transplanting HCV-RNA

Identifiants

pubmed: 37389016
doi: 10.1097/TXD.0000000000001504
pmc: PMC10306429
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e1504

Subventions

Organisme : NIDDK NIH HHS
ID : K08 DK127250
Pays : United States

Informations de copyright

Copyright © 2023 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.

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Auteurs

Peter P Reese (PP)

Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Department of Biostatistics, Epidemiology and Bioinformatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Joshua M Diamond (JM)

Division of Pulmonary Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

David S Goldberg (DS)

Division of Digestive Health and Liver Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL.

Vishnu Potluri (V)

Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Department of Biostatistics, Epidemiology and Bioinformatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Stacey Prenner (S)

Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Emily A Blumberg (EA)

Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Vivianna M Van Deerlin (VM)

Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

K Rajender Reddy (KR)

Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Heather Mentch (H)

Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Richard Hasz (R)

Gift of Life Donor Program, Philadelphia, PA.

Ashley Woodards (A)

Battelle, Washington, DC.

Caren Gentile (C)

Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Jennifer Smith (J)

Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Christian Bermudez (C)

Division of Cardiothoracic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Maria M Crespo (MM)

Division of Pulmonary Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Classifications MeSH