Evidence map›Paper›PMID 32389183›Full record

Trial reportThe lancet. Gastroenterology & hepatology2020

Short-course, direct-acting antivirals and ezetimibe to prevent HCV infection in recipients of organs from HCV-infected donors: a phase 3, single-centre, open-label study.

Jordan J Feld, Marcelo Cypel, Deepali Kumar, Harel Dahari, Rafaela Vanin Pinto Ribeiro, Nikki Marks, Nellie Kamkar, Ilona Bahinskaya, Fernanda Q Onofrio, Mohamed A Zahoor and 15 more

Erratum issued Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. Gastroenterology & hepatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04017338 (Transplantation Using Hepatitis C Positive Donors to Hepatitis C Negative Recipients), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
10.1field-weighted citation impact, top 1% 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.

NCT04017338 phase3unknown statusnot on this map

Transplantation Using Hepatitis C Positive Donors to Hepatitis C Negative Recipients: A Safety Trial

TypeinterventionalSponsorJordan FeldRan2018 to 2024Enrolled40ConditionsLung Transplant Infection, Heart Transplant Infection, Kidney Transplant Infection, Kidney Pancreas InfectionArmsGlecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet, Ezetimibe 10Mg Oral Tablet, Ex Vivo Lung Perfusion
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 101 citations in OpenAlex.

  1. Trial
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  10. Prophylactic 2-week glecaprevir/pibrentasvir in hepatitis C positive-to-negative kidney transplantation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Article
  11. Article
  12. Article
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  15. Review
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  19. Controlled Human Infection Model for Hepatitis C Virus Vaccine Development: Trial Design Considerations.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 5 institutions in 2 countries.

Jordan J FeldToronto Centre for Liver Disease, Toronto, ON, Canada; Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: Jordan.feld@uhn.ca.
Marcelo CypelToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Deepali KumarToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Harel DahariProgram for Experimental and Theoretical Modeling, Division of Hepatology, Department of Medicine, Loyola University Chicago, Chicago, IL, USA.
Rafaela Vanin Pinto RibeiroToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Nikki MarksToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Nellie KamkarToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Ilona BahinskayaToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Fernanda Q OnofrioToronto Centre for Liver Disease, Toronto, ON, Canada; Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Mohamed A ZahoorToronto Centre for Liver Disease, Toronto, ON, Canada; Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Orlando CerrochiToronto Centre for Liver Disease, Toronto, ON, Canada; Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Kathryn TinckamToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
S Joseph KimToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Jeffrey SchiffToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Trevor W ReichmanToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Michael McDonaldToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Carolina AlbaToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Thomas K WaddellToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Gonzalo SapisochinToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Markus SelznerToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Shaf KeshavjeeToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Harry L A JanssenToronto Centre for Liver Disease, Toronto, ON, Canada; Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Bettina E HansenToronto Centre for Liver Disease, Toronto, ON, Canada; Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Lianne G SingerToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Atul HumarToronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada; Soham and Shaila Ajmera Family Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Toronto General Hospital · CAUniversity Health Network · CAUniversity of Toronto · CAToronto Liver Centre · CALoyola University Chicago · US

Funding

Noninvasive Markers and Transplant Outcome in HumansU01AI063594 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HEEGER, PETER SCOTT · 2004 to 2022
$66.5M
Collaborative Integration of HCV Molecular Virology and Mathematical ModelingR01AI078881 · NIAID · UNIVERSITY OF ILLINOIS AT CHICAGO · PI PERELSON, ALAN S, UPRICHARD, SUSAN L. · 2011 to 2025
$7.5M
Observation Study of Persons with Chronic Hepatitis B Virus infection in North AmericaU01DK082874 · NIDDK · UNIVERSITY HEALTH NETWORK · PI JANSSEN, HARRY · 2008 to 2019
$6.9M
Data-Driven Mathematical and Computational Modeling of Hepatitis D Infection and Treatment ResponseR01AI146917 · NIAID · LOYOLA UNIVERSITY CHICAGO · PI DAHARI, HAREL · 2020 to 2024
$3.5M
HEPATITIS C COMMUNITY ALLIANCE FOR TESTING AND TREATMENT IN CHICAGO (HepCCATT)U51PS004607 · PS · UNIVERSITY OF CHICAGO · PI JOHNSON, DANIEL · 2014 to 2015
$3.1M
Collaborative Integration of Hepatitis B Molecular Virology and Mathematical/Computational ModelingR01AI144112 · NIAID · LOYOLA UNIVERSITY CHICAGO · PI DAHARI, HAREL, UPRICHARD, SUSAN L. · 2019 to 2023
$2.2M
Computational discovery of effective hepatitis C intervention strategiesR01GM121600 · NIGMS · LOYOLA UNIVERSITY CHICAGO · PI BOODRAM, BASMATTEE, DAHARI, HAREL · 2017 to 2021
$2.0M
Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis CI01CX001398 · VA · EDWARD HINES JR VA HOSPITAL · PI SCAGLIONE, STEVEN J, UPRICHARD, SUSAN L. · 2017 to 2021
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CSRD VA I01 CX001398NCHHSTP CDC HHS U51 PS004607NIAID NIH HHS R01 AI078881NIAID NIH HHS R01 AI144112NIAID NIH HHS R01 AI146917NIAID NIH HHS U01 AI063594NIAID NIH HHS U01 AI063594–11NIDDK NIH HHS U01 DK082874NIGMS NIH HHS R01 GM121600
6 · The paper itself

Abstract

backgroundAn increasing percentage of potential organ donors are infected with hepatitis C virus (HCV). After transplantation from an infected donor, establishment of HCV infection in uninfected recipients is near-universal, with the requirement for post-transplant antiviral treatment. The aim of this study was to determine if antiviral drugs combined with an HCV entry blocker given before and for 7 days after transplant would be safe and reduce the likelihood of HCV infection in recipients of organs from HCV-infected donors.

methodsHCV-uninfected organ recipients without pre-existing liver disease were treated with ezetimibe (10 mg; an HCV entry inhibitor) and glecaprevir-pibrentasvir (300 mg/120 mg) before and after transplantation from HCV-infected donors aged younger than 70 years without co-infection with HIV, hepatitis B virus, or human T-cell leukaemia virus 1 or 2. Recipients received a single dose 6-12 h before transplant and once a day for 7 days after surgery (eight doses in total). HCV RNA was assessed once a day for 14 days and then once a week until 12 weeks post-transplant. The primary endpoint was prevention of chronic HCV infection, as evidenced by undetectable serum HCV RNA at 12 weeks after transplant, and assessed in the intention-to-treat population. Safety monitoring was according to routine post-transplant practice. 12-week data are reported for the first 30 patients. The trial is registered on ClinicalTrials.gov, NCT04017338. The trial is closed to recruitment but follow-up is ongoing.

findings30 patients (23 men and seven women; median age 61 years (IQR 48-66) received transplants (13 lung, ten kidney, six heart, and one kidney-pancreas) from 18 HCV-infected donors. The median donor viral load was 5·11 log

interpretationEzetimibe combined with glecaprevir-pibrentasvir given one dose before and for 7 days after transplant prevented the establishment of chronic HCV infection in recipients of different organs from HCV-infected donors. This study shows that an ultra-short course of direct-acting antivirals and ezetimibe can prevent the establishment of chronic HCV infection in the recipient, alleviating many of the concerns with transplanting organs from HCV-infected donors.

fundingCanadian Institutes of Health Research; the Organ Transplant Program, University Health Network.

Indexed as

AdultAgedAnticholesteremic AgentsAntiviral AgentsBenzimidazolesCanadaDrug Administration ScheduleDrug CombinationsDrug Therapy, CombinationEzetimibeFemaleGenotypeHepacivirusHepatitis C, ChronicHumansMaleAnticholesteremic AgentsAntiviral AgentsBenzimidazolesDrug CombinationsEzetimibeglecaprevir and pibrentasvirPyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID32389183
PMCPMC7391837
OpenAlexW3022138940

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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.