Utilization of hepatitis C virus–infected organ donors in cardiothoracic transplantation
Publication Date: May 1, 2020
Last Updated: March 14, 2022
Consensus statements
Consensus #1: The donor HCV profile should be characterized by the presence or absence of HCV viremia as detected by NAT and the presence or absence of anti-HCV antibodies as determined by serologic testing. In the case of HCV Ab−/NAT− donors that are considered Public Health Service IRDs, risk factors for HCV acquisition should be taken into account to help guide post-transplant surveillance.
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Consensus # 2: Suitable organs from HCV Ab+/NAT− donors should be routinely accepted for cardiothoracic transplant given the negligible risk of HCV transmission to recipients without need for specific informed consent (unless required under local laws). Suitable organs from NAT+ donors should be considered for consented waitlisted candidates undergoing transplant at centers with established protocols, teams, and resources to manage donor-derived HCV.
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Consensus #3: Given unique challenges related to the use of HCV NAT+ cardiothoracic organs, we recommend HCV-specific informed consent of waitlisted patients before organ offer. In countries where recipients cannot be selective to organ offers, patients should be informed regarding the specific risks associated with HCV NAT+ donors and those associated with declining the offer.
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Consensus #4: At the time of transplant or within 12 months preceding organ offer from an HCV+ donor (as well as anytime there is concern for exposure), the transplant recipient should be tested for pre-existing HCV, HBV, and HIV infection using molecular methods and serology.
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Consensus #5: For centers planning on DAA therapy only after confirmation of HCV infection following transplant from an HCV NAT+ donor, the recipient should be tested for acquisition of donor-derived HCV infection within the first post-operative week using quantitative HCV RNA testing. Once positive, HCV genotyping and resistance testing may be performed, based on whether pan-genotypic DAA will be used or not as well as payer requirements. If quantitative PCR is negative at 1 week post-transplant, serial testing should be performed weekly until infection is confirmed. In those patients who fail to develop viremia by 1 month following transplant, absence of infection should be confirmed by repeat testing at 3 months following transplant. Weekly assessment of liver and renal function for potential adverse events until DAA initiation is recommended as well.
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Consensus #6: Following transplant from an HCV Ab+/NAT− donor, the recipient should undergo quantitative HCV RNA testing at 1 and 3 months for surveillance.
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Consensus #7: We recommend pan-genotypic DAAs for treatment of donor-derived HCV infection in cardiothoracic transplant recipients; genotype-specific DAAs may be used as an alternative. Drug interactions must be carefully evaluated before initiation of DAAs to avoid decreased efficacy of HCV treatment and thereby potential treatment failure.
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Consensus #8: We recommend 1 of 2 approaches to the management of donor-derived HCV infection in transplant recipients:
1. Prophylaxis strategy: Pan-genotypic DAA regimen is initiated pre-operatively or within a few hours following cardiothoracic transplantation from an HCV NAT+ donor with 4 weeks of sofosbuvir/velpatasvir or 8 weeks of glecaprevir/ pibrentasvir.
2. Pre-emptive strategy: After HCV infection acquisition is confirmed, DAA regimen can be started once the patient has recovered from surgery, ideally within 90 days of transplantation. We recommend sofosbuvir/velpatasvir (12 weeks) or glecaprevir/pibrentasvir (8–12 weeks). Alternatives include ledipasvir/sofosbuvir (12 weeks) or elbasvir/grazoprevir (12 weeks) for specific genotypes as per manufacturer recommendations.
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Consensus #9: Quantitative HCV RNA testing should be performed at initiation of DAA, every 4 weeks while on treatment, and following end of treatment until SVR12 is achieved. DAA therapy should not be discontinued or interrupted if HCV viral load is not performed.
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Consensus #10: Induction and maintenance regimens for immunosuppression should be based on local center guidelines. Currently, there is no evidence to suggest that immunosuppression regimens need to be altered when accepting an HCV NAT+ donor.
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Consensus #11: If the recipient has evidence of pre-existing HBV infection (core Ab–positive, PCR-negative, and surface antigen–negative), we recommend periodic HBV PCR and surface antigen surveillance every 3 months for the first year following transplant with consideration of concomitant HBV secondary prophylaxis with lamivudine, entecavir, TDF, or TAF for the duration of DAA therapy.
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Consensus #12: If an HCV NAT+ donor is concomitantly positive for HBV core Ab (but HBV NAT−), serial monitoring for HBV in the recipient using HBV quantitative PCR and surface antigen should be performed every 3 months for the first post-transplant year. If the recipient is not immune to HBV infection (as determined by HBV surface antibody ≥10 mIU/ml), antiviral prophylaxis with lamivudine, entecavir, TDF, or TAF may be considered. If the recipient is immune to HBV, no prophylaxis is needed in the case of donor being HBV core Ab+.
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Consensus #13: Specific patient and care provider education and counseling (as outlined in the consensus document) is recommended for the promotion of medication adherence, recognition of potential adverse events, and prevention of HCV transmission to others.
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Recommendation Grading
Overview
Title
Utilization of hepatitis C virus-infected organ donors in cardiothoracic transplantation
Authoring Organization
International Society for Heart and Lung Transplantation
Publication Month/Year
May 1, 2020
Last Updated Month/Year
February 5, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Inclusion Criteria
Female, Male, Adult, Older adult
Health Care Settings
Ambulatory, Emergency care, Hospital
Intended Users
Physician, nurse, nurse practitioner, physician assistant
Scope
Management, Treatment
Diseases/Conditions (MeSH)
D006505 - Hepatitis, D016031 - Liver Transplantation
Keywords
consensus, donor, hepatitis C virus, HCV, HCV+ transplant, HCV+cardiothoracic transplant, DAA Therapy
Source Citation
Aslam S, Grossi P, Schlendorf KH, Holm AM, Woolley AE, Blumberg E, Mehra MR; working group members. Utilization of hepatitis C virus-infected organ donors in cardiothoracic transplantation: An ISHLT expert consensus statement. J Heart Lung Transplant. 2020 May;39(5):418-432. doi: 10.1016/j.healun.2020.03.004. Epub 2020 Mar 19. PMID: 32362393.