Decision-making Among Hepatitis C Virus-negative Transplant Candidates Offered Organs from Donors with HCV Infection

Saine, M. Elle; Schnellinger, Erin M.; Liu, Michel; Diamond, Joshua M.; Crespo, Maria; Prenner, Stacey; Potluri, Vishnu; Bermúdez, C.; Mentch, Heather; Moore, Michaella; Besharatian, Behdad; Goldberg, David S.; Barg, Frances K.; Reese, Peter P.

doi:10.1097/txd.0000000000001341

Cited by 3 publications

(2 citation statements)

References 61 publications

(97 reference statements)

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“… 36 Although some patients may stigmatize HCV infection, others may simply be focused on the probability of cure or make an instinctive decision to accept HCV-RNA + donor organ transplants. 37 , 38 Humar et al collected free-text responses to examine attitudes and beliefs about lung transplant with HCV-RNA + lungs in a cohort of 67 waitlisted patients who opted-in for HCV-RNA + donor organ offers. Many patients cited a sense of “desperation” in deciding to consider HCV-RNA + donor transplants.…”

Section: Discussionmentioning

confidence: 99%

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

Reese

Diamond

Goldberg

et al. 2023

Transplantation Direct

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Background. 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+ donors and none have reported quality of life (QOL). Methods. 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+ lung recipients to HCV-negative lung recipients in a 1:3 ratio at the same center. Results. Between November 2018 and November 2020, 18 patients were consented and opted-in for HCV-RNA+ lung offers in the allocation system. After a median of 37 d (interquartile range [IQR], 6–373) from opt-in, 10 participants received double lung transplants. The median recipient age was 57 y (IQR, 44–67), and 7 recipients (70%) had chronic obstructive pulmonary disease. The median lung allocation score at transplant was 34.3 (IQR, 32.7–86.9). Posttransplant, 5 recipients developed primary graft dysfunction grade 3 on day 2 or 3, although none required extracorporeal membrane oxygenation. Nine patients received elbasvir/grazoprevir, whereas 1 patient received sofosbuvir/velpatasvir. All 10 patients were cured of HCV and survived to 1 y (versus 83% 1-y survival among matched comparators). No serious adverse events were found to be related to HCV or treatment. RAND-36 scores showed substantial improvement in physical QOL and some improvement in mental QOL. We also examined forced expiratory volume in 1 s—the most important lung function parameter after transplantation. We detected no clinically important differences in forced expiratory volume in 1 s between the HCV-RNA+ lung recipients versus matched comparators. Conclusions. SHELTER adds important evidence regarding the safety of transplanting HCV-RNA+ lungs into uninfected recipients and suggests QOL benefits.

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Section: Discussionmentioning

confidence: 99%

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

Reese

Diamond

Goldberg

et al. 2023

Transplantation Direct

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“…The impact of this new tool is unknown, however, and the underlying models should continue to be scrutinized, refined and updated over time to maximize their usefulness to decision-makers. Lessons from behavioural science [34 ▪ ], more effective shared decision-making between clinicians and patients [36 ▪ ,38], and risk-stratified financial reimbursement [39] also hold promise to improve offer decision-making.…”

Section: Improving Organ Offer Decision-makingmentioning

confidence: 99%

Beyond donation to organ utilization in the USA

Stewart

Lonze

2023

Current Opinion in Organ Transplantation

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Purpose of reviewThe deceased donor organ pool has broadened beyond young, otherwise healthy head trauma victims. But an abundance of donated organs only benefits patients if they are accepted, expeditiously transported and actually transplanted. This review focuses on postdonation challenges and opportunities to increase the number of transplants through improved organ utilization. Recent findingsWe build upon recently proposed changes in terminology for measuring organ utilization. Among organs recovered for transplant, the nonuse rate (NUR REC ) has risen above 25% for kidneys and pancreata. Among donors, the nonuse rate (NUR DON ) has risen to 40% for livers and exceeds 70% for thoracic organs. Programme-level variation in offer acceptance rates vastly exceeds variation in the traditional, 1-year survival benchmark. Key opportunities to boost utilization include donation after circulatory death and hepatitis C virus (HCV)þ organs; acute kidney injury and suboptimal biopsy kidneys; older and steatotic livers.

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Patient Perspectives on Solid Organ Transplantation From Donors With Hepatitis C Viremia to Recipients Without Hepatitis C Viremia

Vanterpool,

Diallo,

Kim

et al. 2024

Open Forum Infectious Diseases

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Background Organ transplantation from donors with hepatitis C viremia (HCV) to recipients without HCV (HCV D+/R−) has excellent medical outcomes. Less is known about the psychosocial impact and experiences of HCV D+/R- recipients, particularly outside of clinical trials. Methods We conducted in-depth, semi-structured interviews with 24 HCV D+/R- recipients (kidney n = 8; lung n = 7; liver n = 5; heart n = 3; simultaneous heart and kidney n = 1) who received transplants outside of clinical trials and were treated for HCV post-transplant to assess their experiences and perspectives. We used thematic analysis to analyze the interviews. Results Interviewees’ reasons for accepting an HCV D + organ were based on perceived benefits and confidence in the effectiveness of HCV treatment. The majority (62%) received HCV treatment within one month post-transplant (range: 1 day - 2 months). Most interviewees reported positive transplant outcomes, including reduced wait times and improved survival, health, physical activity, and quality of life. Overall, themes and experiences did not differ significantly between different organ transplant types. Generally, interviewees did not perceive stigma from those aware of the HCV D + transplant; yet, disclosure was selective and a few recipients reported concerns from family members about post-transplant HCV transmission risk. Other common concerns included treatment costs and delays, which were not always anticipated by recipients. Conclusions Our findings suggest that HCV D+/R- kidney, liver, heart and lung transplant recipients outside of clinical trials had overall positive experiences. However, HCV transmission risk, treatments costs, and treatment delays were a source of concern that might be mitigated with targeted pre-transplant education.

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Decision-making Among Hepatitis C Virus-negative Transplant Candidates Offered Organs from Donors with HCV Infection

Cited by 3 publications

References 61 publications

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

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

Beyond donation to organ utilization in the USA

Patient Perspectives on Solid Organ Transplantation From Donors With Hepatitis C Viremia to Recipients Without Hepatitis C Viremia

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