Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective

Objective: The study objective was to assess the safety and efficacy of a preemptive direct-acting antiviral therapy in lung transplants from hepatitis C virus donors to uninfected recipients. Methods: This study is a prospective, open-label, nonrandomized, pilot trial. Recipients of hepatitis C vir...

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Main Authors: Mauricio A. Villavicencio, MD, Selena S. Li, MD, Ann Marie Leifer, NP, Jenna L. Gustafson, RN, Asishana Osho, MD, Stanley Wolfe, MD, Yuval Raz, MD, Jason Griffith, MD, PhD, Isabel Neuringer, MD, Emily Bethea, MD, Thais Gift, RPh, Georgina Waldman, RPh, Todd Astor, MD, Nathaniel B. Langer, MD, Raymond T. Chung, MD
Format: Article
Language:English
Published: Elsevier 2023-06-01
Series:JTCVS Open
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2666273623000712
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author Mauricio A. Villavicencio, MD
Selena S. Li, MD
Ann Marie Leifer, NP
Jenna L. Gustafson, RN
Asishana Osho, MD
Stanley Wolfe, MD
Yuval Raz, MD
Jason Griffith, MD, PhD
Isabel Neuringer, MD
Emily Bethea, MD
Thais Gift, RPh
Georgina Waldman, RPh
Todd Astor, MD
Nathaniel B. Langer, MD
Raymond T. Chung, MD
author_facet Mauricio A. Villavicencio, MD
Selena S. Li, MD
Ann Marie Leifer, NP
Jenna L. Gustafson, RN
Asishana Osho, MD
Stanley Wolfe, MD
Yuval Raz, MD
Jason Griffith, MD, PhD
Isabel Neuringer, MD
Emily Bethea, MD
Thais Gift, RPh
Georgina Waldman, RPh
Todd Astor, MD
Nathaniel B. Langer, MD
Raymond T. Chung, MD
author_sort Mauricio A. Villavicencio, MD
collection DOAJ
description Objective: The study objective was to assess the safety and efficacy of a preemptive direct-acting antiviral therapy in lung transplants from hepatitis C virus donors to uninfected recipients. Methods: This study is a prospective, open-label, nonrandomized, pilot trial. Recipients of hepatitis C virus nucleic acid test positive donor lungs underwent preemptive direct-acting antiviral therapy with glecaprevir 300 mg/pibrentasvir 120 mg for 8 weeks from January 1, 2019, to December 31, 2020. Recipients of nucleic acid test positive lungs were compared with recipients of lungs from nucleic acid test negative donors. Primary end points were Kaplan–Meier survival and sustained virologic response. Secondary outcomes included primary graft dysfunction, rejection, and infection. Results: Fifty-nine lung transplantations were included: 16 nucleic acid test positive and 43 nucleic acid test negative. Twelve nucleic acid test positive recipients (75%) developed hepatitis C virus viremia. Median time to clearance was 7 days. All nucleic acid test positive patients had undetectable hepatitis C virus RNA by week 3, and all alive patients (n = 15) remained negative during follow-up with 100% sustained virologic response at 12 months. One nucleic acid test positive patient died of primary graft dysfunction and multiorgan failure. Three of 43 nucleic acid test negative patients (7%) had hepatitis C virus antibody positive donors. None of them developed hepatitis C virus viremia. One-year survival was 94% for nucleic acid test positive recipients and 91% for nucleic acid test negative recipients. There was no difference in primary graft dysfunction, rejection, or infection. One-year survival for nucleic acid test positive recipients was similar to a historical cohort of the Scientific Registry of Transplant Recipients (89%). Conclusions: Recipients of hepatitis C virus nucleic acid test positive lungs have similar survival as recipients of nucleic acid test negative lungs. Preemptive direct-acting antiviral therapy results in rapid viral clearance and sustained virologic response at 12 months. Preemptive direct-acting antiviral may partially prevent hepatitis C virus transmission.
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spelling doaj.art-d6522b76f91c4ada96420860c5ffdf0f2023-06-25T04:43:43ZengElsevierJTCVS Open2666-27362023-06-0114602614Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspectiveMauricio A. Villavicencio, MD0Selena S. Li, MD1Ann Marie Leifer, NP2Jenna L. Gustafson, RN3Asishana Osho, MD4Stanley Wolfe, MD5Yuval Raz, MD6Jason Griffith, MD, PhD7Isabel Neuringer, MD8Emily Bethea, MD9Thais Gift, RPh10Georgina Waldman, RPh11Todd Astor, MD12Nathaniel B. Langer, MD13Raymond T. Chung, MD14Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn; Address for reprints: Mauricio A. Villavicencio, MD, Department of Cardiovascular Surgery, 200 First St SW, Rochester, MN, 55905.Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston, MassDivision of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston, MassGastrointestinal Division, Department of Medicine, Massachusetts General Hospital, Boston, MassDivision of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston, MassDivision of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston, MassDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MassDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MassDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MassGastrointestinal Division, Department of Medicine, Massachusetts General Hospital, Boston, MassDivision of Pharmacology, Massachusetts General Hospital, Boston, MassDivision of Pharmacology, Massachusetts General Hospital, Boston, MassDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MassDivision of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston, MassGastrointestinal Division, Department of Medicine, Massachusetts General Hospital, Boston, MassObjective: The study objective was to assess the safety and efficacy of a preemptive direct-acting antiviral therapy in lung transplants from hepatitis C virus donors to uninfected recipients. Methods: This study is a prospective, open-label, nonrandomized, pilot trial. Recipients of hepatitis C virus nucleic acid test positive donor lungs underwent preemptive direct-acting antiviral therapy with glecaprevir 300 mg/pibrentasvir 120 mg for 8 weeks from January 1, 2019, to December 31, 2020. Recipients of nucleic acid test positive lungs were compared with recipients of lungs from nucleic acid test negative donors. Primary end points were Kaplan–Meier survival and sustained virologic response. Secondary outcomes included primary graft dysfunction, rejection, and infection. Results: Fifty-nine lung transplantations were included: 16 nucleic acid test positive and 43 nucleic acid test negative. Twelve nucleic acid test positive recipients (75%) developed hepatitis C virus viremia. Median time to clearance was 7 days. All nucleic acid test positive patients had undetectable hepatitis C virus RNA by week 3, and all alive patients (n = 15) remained negative during follow-up with 100% sustained virologic response at 12 months. One nucleic acid test positive patient died of primary graft dysfunction and multiorgan failure. Three of 43 nucleic acid test negative patients (7%) had hepatitis C virus antibody positive donors. None of them developed hepatitis C virus viremia. One-year survival was 94% for nucleic acid test positive recipients and 91% for nucleic acid test negative recipients. There was no difference in primary graft dysfunction, rejection, or infection. One-year survival for nucleic acid test positive recipients was similar to a historical cohort of the Scientific Registry of Transplant Recipients (89%). Conclusions: Recipients of hepatitis C virus nucleic acid test positive lungs have similar survival as recipients of nucleic acid test negative lungs. Preemptive direct-acting antiviral therapy results in rapid viral clearance and sustained virologic response at 12 months. Preemptive direct-acting antiviral may partially prevent hepatitis C virus transmission.http://www.sciencedirect.com/science/article/pii/S2666273623000712lung transplantationhepatitis Coutcomesantivirals
spellingShingle Mauricio A. Villavicencio, MD
Selena S. Li, MD
Ann Marie Leifer, NP
Jenna L. Gustafson, RN
Asishana Osho, MD
Stanley Wolfe, MD
Yuval Raz, MD
Jason Griffith, MD, PhD
Isabel Neuringer, MD
Emily Bethea, MD
Thais Gift, RPh
Georgina Waldman, RPh
Todd Astor, MD
Nathaniel B. Langer, MD
Raymond T. Chung, MD
Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective
JTCVS Open
lung transplantation
hepatitis C
outcomes
antivirals
title Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective
title_full Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective
title_fullStr Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective
title_full_unstemmed Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective
title_short Preemptive antiviral therapy in lung transplantation from hepatitis C donors results in a rapid and sustained virologic responseCentral MessagePerspective
title_sort preemptive antiviral therapy in lung transplantation from hepatitis c donors results in a rapid and sustained virologic responsecentral messageperspective
topic lung transplantation
hepatitis C
outcomes
antivirals
url http://www.sciencedirect.com/science/article/pii/S2666273623000712
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