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BACKGROUND: In kidney transplantation, concerns have been raised regarding increased incidence of viral opportunistic infections in hepatitis C virus (HCV) nucleic acid test (NAT)-negative (-) recipients who received HCV NAT-positive (+) donor kidneys, specifically BK polyomavirus (BKPyV), cytomegalovirus (CMV), and Epstein-Barr virus (EBV). The purpose of this study was to determine the incidence of these three viral opportunistic infections in HCV NAT- recipients who have undergone kidney transplantation with HCV NAT+ donor kidneys at our institution. METHODS: This was an Institutional Review Board-approved, single-center, retrospective case-control study of HCV NAT- kidney transplant recipients with HCV NAT+ donors from 2018 to 2021. The primary outcome was the cumulative incidence of viral infections of BKPyV, CMV, and/or EBV within 1 year following kidney transplantation. RESULTS: A total of 231 patients were included, 77 in the exposed (donor HCV NAT+) group and 154 in the control (donor HCV NAT-) group. The adjusted cumulative incidence of viremia within 1 year did not statistically differ between groups (77% exposed group versus 66% for the control group, hazard ratio 1.34, 95% confidence interval 0.95-1.89). In addition, no statistically significant differences were observed for secondary outcomes with the exception of CMV viremia (62% exposed versus 49% control, p = 0.021). However, there were more patients in the exposed group at high risk for CMV viremia based on serostatus (CMV Donor+/Recipient-, D+/R-). CONCLUSION: Among patients who received HCV NAT+ donor kidneys, no clear association was observed between exposure to HCV NAT+ donor kidneys and viral infections of BKPyV, CMV, or EBV.
RESUMEN
PURPOSE: An institutional workflow developed by clinical pharmacists for initiation of directing-acting antiviral (DAA) therapy for patients who receive solid organ transplants from hepatitis C (HCV)-positive donors is described; programmatic challenges in providing pharmaceutical care to these patients are reviewed. SUMMARY: In recent years the introduction of new oral DAAs, coupled with faster screening of donor organs for HCV infection through use of a nucleic acid test (NAT), has facilitated transplants of organs from HCV-seropositive donors to HCV-seronegative recipients. The solid organ transplant program of a North Carolina health system began performing such transplants in December 2017. In the pharmacist-developed workflow, patients are initiated on DAA therapy in the outpatient clinic setting, and clinic pharmacists are consulted regarding drug selection. Prescriptions for DAA therapy are sent to an on-site specialty pharmacy, where pharmacists and pharmacy technicians work to obtain prior authorization and, if necessary, payment assistance through manufacturer-sponsored programs. The medical team is notified at the time of patient approval to begin treatment. Pharmacists provide counseling at the time of DAA therapy initiation and follow up with patients every 2 weeks to confirm adherence. As of June 2019, about 100 transplants of HCV NAT-positive organs had been performed (approximately 50% were kidney transplants; 15%, lung transplants; 20%, heart transplants; and 15%, liver transplants). Many challenges are encountered in the process of providing pharmaceutical care to this patient population, including challenges in patient selection and counseling, overcoming financial barriers and insurance restrictions, and coordinating with an internal specialty pharmacy to ensure timely delivery of medication to patients. CONCLUSION: Within a solid organ transplantation program, clinical pharmacists and other pharmacy personnel can play vital roles in ensuring safe and effective DAA therapy for recipients of transplanted HCV NAT-positive organs.