Expanding the Deceased Donor Pool in Manitoba Using Hepatitis C-Viremic Donors: Program Report

被引:3
作者
Cuvelier, Susan [1 ]
Van Caeseele, Paul [2 ]
Kadatz, Matthew [3 ]
Peterson, Kathryn [4 ]
Sun, Siyao [4 ]
Dodd, Nancy [4 ]
Werestiuk, Kim [4 ]
Koulack, Joshua [5 ]
Nickerson, Peter [4 ,6 ,7 ]
Ho, Julie [4 ,6 ,7 ]
机构
[1] Univ Manitoba, Dept Internal Med, Sect Hepatol, Winnipeg, MB, Canada
[2] Cadham Prov Lab, Winnipeg, MB, Canada
[3] Univ British Columbia, Dept Med, Div Nephrol, Vancouver, BC, Canada
[4] Transplant Manitoba Adult Kidney Program, Winnipeg, MB, Canada
[5] Univ Manitoba, Dept Surg, Sect Vasc Surg, Winnipeg, MB, Canada
[6] Univ Manitoba, Dept Internal Med, Sect Nephrol, Winnipeg, MB, Canada
[7] Univ Manitoba, Dept Immunol, Winnipeg, MB, Canada
关键词
high infectious risk donor; direct-acting anti-viral agents; glecaprevir-pibrentasvir; nucleic acid testing; hepatitis C; KIDNEY-TRANSPLANTATION; SEXUAL TRANSMISSION; INFECTED DONORS; POSITIVE DONORS; HCV INFECTION; SINGLE-CENTER; RECIPIENTS; VIRUS; COUPLES; ORGANS;
D O I
10.1177/20543581211033496
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Purpose of program: The ongoing shortage of organs for transplant combined with Manitoba having the highest prevalence of end-stage renal disease (ESRD) in Canada has resulted in long wait times on the deceased donor waitlist. Therefore, the Transplant Manitoba Adult Kidney Program has ongoing quality improvement initiatives to expand the deceased donor pool. This clinical transplant protocol describes the use of prophylactic pan-genotypic direct-acting anti-viral agents (DAA) for transplanting hepatitis C (HCV)-viremic kidneys (HCV antibody positive/nucleic acid [nucleic acid amplification testing, NAT] positive) to HCV-naive recipients as routine standard of care. We will evaluate the provincial implementation of this protocol as a prospective observational cohort study. Sources of information: Scoping literature review and key stakeholder engagement with interdisciplinary health care providers and health system leaders/decision markers. Methods: Patients will be screened pre-transplant for eligibility and undergo a multilevel education and consent process to participate in this expanded donor program. Incident adult HCV-naive recipients of an HCV-viremic kidney transplant will be treated prophylactically with glecaprevir-pibrentasvir with the first dose administered on call to the operation. Glecaprevir-pibrentasvir will be used for 8 weeks with viral monitoring and hepatology follow-up. Primary outcomes are sustained virologic response (SVR) at 12 weeks and the tolerability of DAA therapy. Secondary outcomes within the first year post-transplant are patient and graft survival, graft function, biopsy-proven rejection, HCV transmission to recipient (HCV NAT positive), and HCV nonstructural protein 5A (NS5A) resistance. Safety outcomes within the first year post-transplant include fibrosing cholestatic hepatitis, acute liver failure, primary and secondary DAA treatment failure, HCV transmission to a recipient's partner, elevated liver enzymes >= 2-fold, abnormal international normalized ratio (INR), angioedema, anaphylaxis, cirrhosis, and hepatocellular carcinoma. Key findings: This program successfully advocated for and obtained hospital formulary, provincial Exceptional Drug Status (EDS), and Non-Insured Health Benefits (NIHB) to provide prophylactic DAA therapy for this indication, and this information may be useful to other provincial transplant organizations seeking to establish an HCV-viremic kidney transplant program with prophylactic DAA drug coverage. Limitations: (1) Patient engagement was not undertaken during the program design phase, but patient-reported experience measures will be obtained for continuous quality improvement. (2) Only standard criteria donors (optimal kidney donor profile index [KDPI] <= 60) will be used. If this approach is safe and feasible, then higher KDPI donors may be included.
引用
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页数:10
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