Pancreas transplantation from hepatitis C viremic donors to uninfected recipients

Lonze, Bonnie E.; Baptiste, Gillian; Ali, Nicole; Dagher, Nabil N.; Gelb, Bruce; Mattoo, Aprajita; Soomro, Irfana; Tatapudi, Vashista S; Montgomery, Robert A.; Stewart, Zoe A.

doi:10.1111/ajt.16465

Cited by 11 publications

(9 citation statements)

References 28 publications

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“…Numerous studies have demonstrated the safety and efficacy of organ transplantation from HCV + donors to HCVrecipients. [6][7][8][9][10][11][12][13][14] Critical challenges remain to establish standard best practices that maximize benefit and minimize risk with the increased utilization of HCV + organs. Concerns for the feasibility of safely performing these transplants in "realworld" practice have been raised, leading some to suggest that these transplants should be restricted to sites running formal research protocols.…”

Section: Discussionmentioning

confidence: 99%

“…These studies yielded encouraging results 2,4 and have been followed by singlecenter reports of this practice in all solid organ types. [6][7][8][9][10][11][12][13][14] The overarching messaging from these reports is that transplanting HCV + donor organs into HCVrecipients is safe and that posttransplant cure of donor-derived HCV infection is nearly universal. The merits of this practice are notable: decreasing discards of otherwise excellent donor organs 15 and transplanting patients more quickly with grafts that appear to perform well.…”

Section: Introductionmentioning

confidence: 99%

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Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections

Stewart

Stern

Ali

et al. 2021

Transplantation Direct

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Infectious DiseaseBackground. Transplanting hepatitis C viremic donor organs into hepatitis C virus (HCV)-negative recipients is becoming increasingly common; however, practices for posttransplant direct-acting antiviral (DAA) treatment vary widely. Protracted insurance authorization processes for DAA therapy often lead to treatment delays. Methods. At our institution, 2 strategies for providing DAA therapy to HCVrecipients of HCV + transplants have been used. For thoracic organ recipients, an institution-subsidized course of initial therapy was provided to ensure an early treatment initiation date. For abdominal organ recipients, insurance approval for DAA coverage was sought once viremia developed, and treatment was initiated only once the insurance-authorized supply of drug was received. To evaluate the clinical impact of these 2 strategies, we retrospectively collected data pertaining to the timing of DAA initiation, duration of recipient viremia, and monetary costs incurred by patients and the institution for patients managed under these 2 DAA coverage strategies. Results. One hundred fifty-two transplants were performed using HCV viremic donor organs. Eighty-nine patients received DAA treatment without subsidy, and 62 received DAA treatment with subsidy. One patient who never developed viremia posttransplant received no treatment. Subsidizing the initial course enabled earlier treatment initiation (median, 4 d [interquartile range (IQR), 2-7] vs 10 [IQR, 8-13]; P < 0.001) and shorter duration of viremia (median, 16 d [IQR,(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29) vs 36 [IQR,[30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47]; P < 0.001). Institutional costs averaged $9173 per subsidized patient and $168 per nonsubsidized patient. Three needlestick exposures occurred in caregivers of viremic patients. Conclusions. Recipients and their caregivers stand to benefit from earlier DAA treatment initiation; however, institutional costs to subsidize DAA therapy before insurance authorization are substantial. Insurance authorization processes for DAAs should be revised to accommodate this unique patient group.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections

Stewart

Stern

Ali

et al. 2021

Transplantation Direct

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“…Direct-acting antivirals (DAAs) reach high rates of sustained virological response (SVR) of more than 90%13 14 and have significantly impacted the pool of available organs for transplantation. The widespread use of DAA increased the number of transplant candidates, who are cleared of HCV, shortened their transplant waiting time and reduced their mortality rates 15–20. However, several reasons contribute to DAA treatment failure, such as genotype, treatment nativity and duration, non-adherence, drug–drug interactions (DDI), inadequate drug concentrations because of malassimilation and resistance-associated substitutions (RAS) 21.…”

Section: Introductionmentioning

confidence: 99%

Newly diagnosed hepatitis C infection after pancreas transplantation with multiple treatment failures

2023

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This case represents the first report of a detected hepatitis C virus (HCV) infection following a pancreas transplantation that failed two different sofosbuvir (SOF)-based treatments. We present the case of a woman in her 30s with a history of kidney transplantation, who developed viremic symptoms 3 months after pancreas transplantation and with two subsequent negative HCV antibody tests. Further work-up revealed a positive HCV RNA test (genotype 1A, treatment naive). Two different direct-acting antiviral agents regimes with SOF failed in our case, and the patient achieved a sustained virological response with a 16-week course of glecaprevir/pibrentasvir.

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“…The advent of highly efficacious, pangenotypic direct‐acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infection has allowed the safe transplantation of organs from HCV viremic (HCV+) donors (D) into HCV negative (HCV–) recipients (R) pool 1–5 . Since 2017, multiple clinical series have demonstrated the safety and efficacy of HCV+ to HCV– (HCV D+/R–) organ transplantation, with the cure rates for donor‐derived HCV infection approaching 100% 1,2,6–11 . However, significant adverse events such as fibrosing cholestatic hepatitis and acute rejection have been reported 12–15 .…”

Section: Introductionmentioning

confidence: 99%

Caregiver exposure to hepatitis C virus following transplantation with hepatitis C viremic donor organs: A case series

Kim

Stern

Weldon

et al. 2022

Transplant Infectious Dis

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Direct-acting antiviral (DAA) therapeutics have ushered in an era in which transplanting organs from donors infected with hepatitis C virus (HCV+) into recipients without (HCV-) is an increasingly common practice. Rare but potentially life-threatening events have been reported in recipients of HCV+ organs. Since 2018 at our institution, 182 HCV-patients have received HCV+ donor organs. Here, we retrospectively reviewed cases in which recipients' family member caregivers reported sustaining needlestick exposures at home following discharge of the transplant recipient from the hospital. Caregiver needlestick exposures were passively reported in three cases of HCV+ into HCV-transplants (1.64% of such cases at our center). In all instances, the exposed individuals were aiding in diabetic management and the exposure occurred via lancets or insulin needles. In one case, the recipient viral load was undetectable at the time of the exposure but in the other two, recipients were viremic, putting their family members at risk to contract HCV infection. Surveillance for the exposed individuals was undertaken and no transmissions occurred. For centers performing HCV+ into HCV-transplants, it is important that informed consent includes discussion of potential secondary risks to family members and caregivers. Further, protocols for postexposure surveillance and for the acquisition of DAA treatment in the event of a secondary transmission should be in place.

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Pancreas transplantation from hepatitis C viremic donors to uninfected recipients

Cited by 11 publications

References 28 publications

Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections

Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections

Newly diagnosed hepatitis C infection after pancreas transplantation with multiple treatment failures

Caregiver exposure to hepatitis C virus following transplantation with hepatitis C viremic donor organs: A case series

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