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      Patient’s Perspectives of Experimental HCV-positive to HCV-negative Renal Transplantation

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          Abstract

          Background:

          With growing transplant wait times, clinical trials are evaluating the safety and efficacy of transplanting HCV-infected donor (HCV+) organs into HCV-noninfected recipients (HCV D+/R-). Such transplants raise ethical questions about safety, consent, and access to organs.

          Methods:

          We interviewed eight of the ten total HCV D+/R− transplant recipients enrolled in a pilot clinical trial examining the safety and feasibility of these novel transplants regarding their experiences in the trial, including their decision-making and perceptions of the informed consent process.

          Results:

          All interviewees reported positive experiences and expressed confidence regarding their decision to participate. Participants accepted an HCV+ organ based on their assessments of the risks and potential benefits of HCV D+/R− transplants. For many, the risks of HCV were minimal compared to the risks of not receiving a transplant. All participants recalled providing informed consent, reporting that the process was thorough and that all their questions were addressed. Participants did not regret receiving an HCV D+/R− transplant and did not report experiencing stigma. However, given their understanding of HCV cure rates in the general population and the survival benefit associated with kidney transplantation, participants may have conflated research regarding HCV D+/R− transplantation with clinical care, suggesting potential therapeutic misconception.

          Conclusions:

          Recipients of experimental HCV D+/R− transplants generally seemed to recognize the risks and benefits of these novel transplants and did not regret participating. Such salutary reported experiences are important in assessing the appropriateness of further research into the feasibility of HCV D+/R− transplants.

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          Author and article information

          Journal
          101631047
          42496
          AJOB Empir Bioeth
          AJOB Empir Bioeth
          AJOB empirical bioethics
          2329-4515
          2329-4523
          9 October 2019
          16 October 2019
          Jan-Mar 2020
          01 January 2021
          : 11
          : 1
          : 40-52
          Affiliations
          [(1) ]Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD.
          [(2) ]Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD
          [(3) ]Department of Epidemiology, Johns Hopkins University School of Medicine, Baltimore, MD.
          [(4) ]Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD.
          Author notes
          CONTACT INFORMATION Jeremy Sugarman, 1809 Ashland Ave, Baltimore MD 21205, 410-614-5634, jsugarman@ 123456jhu.edu

          AUTHOR CONTRIBUTIONS:

          SE Van Pilsum Rasmussen participated in study design, data collection, data analysis, data interpretation, and drafting of the manuscript. S Seaman participated in data analysis, data interpretation, and drafting of the manuscript. D Brown, N Desai, M Sulkowski, and DL Segev participated in data interpretation, and drafting of the manuscript. CM Durand and J Sugarman participated in study conception, study design, data interpretation, and drafting of the manuscript.

          Author information
          http://orcid.org/0000-0002-4644-3590
          http://orcid.org/0000-0002-0457-3506
          http://orcid.org/0000-0002-2145-6352
          http://orcid.org/0000-0002-1924-4801
          http://orcid.org/0000-0003-2605-9257
          Article
          PMC7044044 PMC7044044 7044044 nihpa1540946
          10.1080/23294515.2019.1670277
          7044044
          31618112
          c88a7cff-c205-4cd0-8db7-9056c37e7cf9
          History
          Categories
          Article

          interview,qualitative research,hepatitis C,research ethics,transplantation

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