Incidence of opportunistic viral infections in hepatitis C virus nucleic acid test negative recipients of kidneys from hepatitis C virus nucleic acid test positive donors.

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.

Antiviral Treatment Failures After Transplantation of Organs From Donors With Hepatitis C Infection: A Report of 4 Cases.

The transplantation of organs from donors with hepatitis C virus (HCV) infection into uninfected recipients has expanded the available organ donor pool. With the advancement of direct-acting antivirals (DAAs), high rates of cure among transplant recipients are possible. Although DAAs are highly effective, treatment failure can occur following an appropriate 12-week course of a pan-genotypic regimen. Here we describe 4 kidney transplant recipients of organs from donors with HCV infection (3 with genotype 3, 1 genotype 1a) in whom first-line DAA treatment with either glecaprevir-pibrentasvir or sofosbuvir-velpatasvir was unsuccessful, started 22-35 days after the day of transplantation. All ultimately achieved sustained virologic response with second- or third-line therapy. Post-treatment resistance-associated substitutions were tested and noted to be present in 2 cases. Additionally, antiviral levels were assessed in 2 cases and found to be therapeutic in each. This article explores possible reasons for treatment failure, including medication interactions, bariatric surgery, viral dynamics, and drug resistance.

Daratumumab Use Prior to Kidney Transplant and T Cell-Mediated Rejection: A Case Report.

There is growing interest in daratumumab in the solid organ transplant realm owing to the potential immunomodulatory effects on CD38-expressing cells, primarily plasma cells, as they have a key role in antibody production. In particular there is interest in use of daratumumab for desensitization and potential treatment for antibody-mediated rejection. However, ongoing investigation with daratumumab has shown potential immunologic concerns in vitro, with a significant increase in populations of CD4-positive cytotoxic T cells and CD8-positive helper T cells in both peripheral blood and bone marrow that could lead to acute T cell-mediated rejection in the solid organ transplant patient. To date, there are no published reports of an association with daratumumab use and T cell-mediated rejection in vivo. In this case report we present what is to our knowledge the first documented case of an early severe T cell-mediated rejection in a low-immunologic-risk living-donor kidney transplant recipient who received daratumumab for multiple myeloma maintenance prior to transplant.

Delayed vs initial cytomegalovirus prophylaxis after kidney transplantation.

It is recommended to start cytomegalovirus (CMV) prophylaxis within 10 days of solid organ transplant, if indicated. Our center underwent a cost-savings initiative to delay CMV prophylaxis initiation from postoperative day zero to postoperative day 7 or upon discharge, hypothesizing this would not affect clinical outcomes but could impact costs. The purpose of this retrospective study was to determine the effects of early vs delayed (<72 vs >72 hours after transplant) CMV prophylaxis in kidney and kidney/pancreas transplant recipients transplanted between June 2014 and January 2017. The primary endpoint was incidence of CMV infection within 1 year. Secondary endpoints included CMV disease, CMV testing, and valganciclovir cost during index hospitalization. A total of 173 patients (114 early, 59 delayed) were included. CMV infection occurred in 61% vs 54% in the early vs delayed group (P = .5). Excluding low-level DNAemia (QNAT < 200 IU/mL), infection occurred in 30% vs 22% in the early vs late group (P = .4). The median days to starting prophylaxis were 0 and 6 in the early and delayed group (P < .05), which led to a median cost savings of $497.00 per patient during index hospitalization (P < .05). Delaying prophylaxis initiation did not impact CMV outcomes in this cohort and decreased costs.

Effect of HMG CoA reductase inhibitors on the development of chronic lung allograft dysfunction.

Lung transplant recipients (LRs) have a reduced median 5-year survival of approximately 55% primarily due to chronic lung allograft dysfunction (CLAD). Statins have anti-inflammatory and immunomodulatory effects that may facilitate CLAD prevention. This study sought to evaluate statin effect on CLAD development. Adult bilateral LRs from January 2004 to October 2013 were included. Statin group included recipients with early statin use and continued for minimum 6 months. Propensity score matching was performed for age, gender, and native lung disease to select matched nonstatin group. Competing risk approach was used to evaluate statin effect on CLAD development at 3 years while controlling for acute rejection and CMV pneumonitis. A total of 130 patients were included in each group. CLAD cumulative incidence at 3 years for statin and nonstatin groups was 20.6% (CI: 11.8%-33.5%) and 22.4% (CI: 12.2%-27.3%). Statin use was not associated with a decreased risk of CLAD (subdistribution hazard ratio [SHR]: 0.93, 95% CI: 0.55-1.59, P = .80) but was associated with a decreased risk of death (SHR: 0.45, CI: 0.22-0.90, P = .024). At 3 years, patient survival was 81.7% in statin group and 68.3% in nonstatin group (P = .012). Statins did not significantly delay the time to development of CLAD in LR but did demonstrate a benefit in patient survival.

Incidence of acute cellular rejection following granulocyte colony-stimulating factor administration in lung transplantation: A retrospective case-cohort analysis.

Granulocyte colony-stimulating factor (GCSF) is an option to treat leukopenia in lung transplant recipients. Conflicting evidence exists regarding its effects on acute cellular rejection (ACR). A retrospective, case-cohort study was conducted to assess whether the use of GCSF in lung transplant recipients is associated with an increased incidence of ACR. Patients had to have received at least one dose of GCSF but were excluded if they received GCSF within 30 days prior to transplant or received a lymphocyte-depleting agent within 14 days of GCSF administration. Thirty-five patients who received GCSF within 3 months of transplant met inclusion criteria and 105 patients were identified as controls based on a 1:3 allocation scheme. Incidence of ACR was 57.1% in the GCSF group versus 50.5% in the control group (relative risk (RR)=1.13; 95% CI, 0.80 to 1.59; P=.48). At 3 months post-transplant, 74.3% of the GCSF group had a dose reduction or discontinuation of their antiproliferative agent versus 17.1% of the control group (RR=4.33; 95% CI, 2.73 to 6.89; P<.0001). Rejection severity and incidence of infections was similar among groups. These findings show that GCSF administration within 3 months following lung transplantation was not associated with a higher incidence or severity of ACR.

Antibody depletion strategy for the treatment of suspected antibody-mediated rejection in lung transplant recipients: Does it work?

BACKGROUND: Donor-specific antibodies (DSAs) after lung transplantation correlate with poor outcomes. The ideal treatment strategy for antibody-mediated rejection AMR is not defined. Our institution implemented an aggressive multimodality protocol for the treatment of suspected AMR. METHODS: Lung transplant recipients with suspected AMR were treated with a standardized protocol of plasma exchange, steroids, bortezomib, rituximab, and intravenous immune globulin. Primary outcome was DSA clearance at 6 months in those alive. Secondary endpoints included preserved allograft function at 6 months, survival at 6 and 12 months and complications due to the protocol. RESULTS: Sixteen lung transplant recipients with documented DSA and allograft dysfunction were included in the analysis. Of the 16 patients, 11 survived to 6 months. Three of those 11 patients (27%) cleared all DSAs within 6 months of the protocol. Four of the 11 patients (36%) had preserved allograft function at 6 months. Overall 12-month patient survival was 56%. Complications included thrombocytopenia (50%) and abdominal pain or gastrointestinal discomfort (18.7%). CONCLUSIONS: This multimodality protocol resulted in clearance of DSAs and preserved lung function in a minority of lung transplant recipients with suspected AMR surviving to 6 months after therapy. There were significant side effects of the protocol.

Bridging the gap: assessing CMV DNAemia in kidney transplant recipients with previous solid organ transplants.

Cytomegalovirus (CMV) infection poses a significant threat to solid organ transplant (SOT) recipients and can lead to various complications and adverse outcomes. In an effort to prevent CMV infection, it is common to utilize prophylactic strategies, including antiviral medications such as valganciclovir, especially for high-risk patients. Risk factors for CMV infection in kidney transplant recipients (KTRs) include CMV mismatch between donor and recipient (i.e., donor positive, recipient negative), and intensity of immunosuppression, such as the use of T-cell depleting agents. However, little attention has been given to KTRs with a history of prior SOTs, despite their prolonged exposure to immunosuppressive regimens. The aim of this retrospective single-center study was to investigate the incidence and implications of CMV DNAemia in KTRs with prior SOTs. The study included 97 KTRs with prior SOTs and 154 KTRs with no prior transplants as a control group. In the study group, the most common SOT before the current kidney transplantation (KT), was a previous KT. Patients in the KTR group with prior SOTs were more sensitized than those in the control group [calculated panel-reactive antibody > 30%: 49 (50.5%) vs. 30 (19.45%) patients, p = 0.001]. There was a 39.2% incidence of CMV DNAemia in the previous SOT group compared to 48.7% in the control group [non-significant (NS)]. Patients with prior SOTs demonstrated a shorter post-transplant time to CMV DNAemia [median time 1.6 months (interquartile range, IQR 0.7-5.8) in the KTRs with prior SOTs vs. 2.6 months (IQR 1.5-8.1) in the control group (p = 0.001)]. Although the study highlights the need for tailored prophylaxis strategies and vigilant monitoring in KTRs with prior SOTs, its limitations, such as its retrospective nature and single-center design, call for further multicenter research to establish comprehensive guidelines for managing CMV DNAemia in this unique patient population. Despite these limitations, this study underscores the importance of recognizing the heightened risk of CMV infection or reactivation in KTRs overall and the potential benefits of proactive intervention to mitigate associated morbidity and mortality.

Evaluation of Tacrolimus Concentrations and Clinical Outcomes Between Extended and Immediate Release Formulations in Kidney Transplant.

Objectives: Tacrolimus remains the mainstay of immunosuppression in kidney transplantation. Understanding the relationship between therapeutic tacrolimus levels and outcomes of acute rejection, patient/graft survival, and tolerability are important. The relationship between time to therapeutic tacrolimus levels and outcomes has not been well established, specifically with the use of extended release tacrolimus formulation (LCP-Tac). This study investigated time to therapeutic tacrolimus levels of 2 tacrolimus formulations, LCP-Tac and immediate release tacrolimus (IR-Tac), as a predictor of clinical outcomes. Methods: This was a single-center, retrospective, cohort study of kidney transplant recipients at Duke Hospital between 2013-2021. The primary objective evaluated the difference in time to therapeutic tacrolimus levels with LCP-Tac vs IR-Tac regimens. Secondary endpoints included time within therapeutic range during the first 3 months post-transplant, incidence of biopsy-proven rejection, development of de novo donor specific antibodies, and patient and allograft survival at 12 months post-transplant. Results: 128 patients were included (63 in LCP-Tac group and 65 in IR-Tac group). The time to therapeutic tacrolimus level was similar between formulations (7.2 days with LCP-Tac compared to 6.7 days with IR-Tac, P = .63). The time within therapeutic range during the first 3 months post-transplant, via modified Rosendaal, was similar with LCP-Tac and IR-Tac (56.1% vs 64.8%, respectively). Rates of biopsy-proven acute rejection at 12 months were similar (7/63 (11.1%) compared to 4/65 (6.2%)). There was no difference in patient/graft survival between groups. Conclusions: The time to therapeutic tacrolimus levels did not differ based on tacrolimus formulation and was not correlated with clinical outcomes.

Use of Letermovir for Primary and Secondary Cytomegalovirus Prophylaxis in Abdominal Organ Transplantation: A Single Center Experience.

BACKGROUND: Cytomegalovirus (CMV) infection after abdominal organ transplantation is associated with increased morbidity and mortality. The use of valganciclovir for CMV prophylaxis is limited by drug-induced myelosuppression and potential emergence of resistance. Letermovir is approved for primary CMV prophylaxis in CMV seropositive allogeneic hematopoietic cell transplant recipients. However, it is increasingly used off-label for prophylaxis in solid organ transplant (SOT) recipients. METHODS: Based on pharmacy records, we examined retrospectively the use of letermovir for CMV prophylaxis in abdominal transplant recipients initiated on therapy at our center from January 1, 2018 through October 15, 2020. Data were summarized using descriptive statistics. RESULTS: Twelve episodes of letermovir prophylaxis occurred in ten patients. Four patients received primary and 6 patients received secondary prophylaxis during the study period, with 1 patient receiving letermovir secondary prophylaxis on 3 separate occasions. All patients receiving letermovir for primary prophylaxis had successful outcomes. However, letermovir secondary prophylaxis was unsuccessful in 5 of the 8 episodes (62.5%) due to breakthrough CMV DNAemia and/or disease. Only 1 patient discontinued therapy due to adverse effects. CONCLUSION: Although letermovir was generally well tolerated, the high rate of failure when used as secondary prophylaxis was noteworthy. Additional controlled clinical trials assessing the safety and efficacy of letermovir prophylaxis in SOT recipients are warranted.

Evaluation of Weight-Based Dose During Transition From Immediate-Release to Extended-Release Tacrolimus in Kidney Transplant Recipients.

BACKGROUND: Manufacturer recommendations for conversion from immediate-release to extended-release tacrolimus, Envarsus XR®, suggests 80% of the total daily dose of the immediate-release formulation. This conversion has not consistently achieved therapeutic levels in the kidney transplant population. OBJECTIVES: To determine if a reliable weight-based dosing strategy could be utilized to transition kidney transplant patients from immediate-release to extended-release tacrolimus. This may help establish a safe protocol to guide transition between formulations. METHODS: Retrospective, single-center study of adult kidney transplant recipients between July 2015 and December 2018. Excluded patients received dual organs, lacked appropriately drawn tacrolimus levels, or were prescribed interacting medications. Patients were identified by querying prescriptions for extended-release tacrolimus and chart review was performed to exclude any patients without sufficient follow-up after transition. RESULTS: 30 patients who transitioned from immediate-release tacrolimus to tacrolimus XR were included in the final analysis. The median weight-based dose of tacrolimus XR that achieved a therapeutic level among the cohort was 0.158 mg/kg/day (Q1-Q3: 0.0587-0.221), which was about 80% of the original median weight-based immediate-release tacrolimus dose. Therapeutic dosing strategies were widely variable, represented by an R2 of 0.33 on linear regression. There was a statistically significant difference in median weight-based dosing strategies among patients of various racial backgrounds (p = 0.0148). CONCLUSIONS: A weight-based dose of tacrolimus XR could not reliably predict a therapeutic level among the total cohort due to the wide inter-patient variability. The median weight-based rate of conversion from immediate-release to extended-release tacrolimus was 80%.

Transcriptional responses define dysregulated immune activation in Hepatitis C (HCV)-naïve recipients of HCV-infected donor kidneys.

Renal transplantation from hepatitis C (HCV) nucleic acid amplification test-positive (NAAT-positive) donors to uninfected recipients has greatly increased the organ donation pool. However, there is concern for adverse outcomes in these recipients due to dysregulated immunologic activation secondary to active inflammation from acute viremia at the time of transplantation. This includes increased rates of cytomegalovirus (CMV) DNAemia and allograft rejection. In this study, we evaluate transcriptional responses in circulating leukocytes to define the character, timing, and resolution of this immune dysregulation and assess for biomarkers of adverse outcomes in transplant patients. We enrolled 67 renal transplant recipients (30 controls, 37 HCV recipients) and performed RNA sequencing on serial samples from one, 3-, and 6-months post-transplant. CMV DNAemia and allograft rejection outcomes were measured. Least absolute shrinkage and selection operator was utilized to develop gene expression classifiers predictive of clinical outcomes. Acute HCV incited a marked transcriptomic response in circulating leukocytes of renal transplant recipients in the acute post-transplant setting, despite the presence of immunosuppression, with 109 genes significantly differentially expressed compared to controls. These HCV infection-associated genes were reflective of antiviral immune pathways and generally resolved by the 3-month timepoint after sustained viral response (SVR) for HCV. Differential gene expression was also noted from patients who developed CMV DNAemia or allograft rejection compared to those who did not, although transcriptomic classifiers could not accurately predict these outcomes, likely due to sample size and variable time-to-event. Acute HCV infection incites evidence of immune activation and canonical antiviral responses in the human host even in the presence of systemic immunosuppression. After treatment of HCV with antiviral therapy and subsequent aviremia, this immune activation resolves. Changes in gene expression patterns in circulating leukocytes are associated with some clinical outcomes, although larger studies are needed to develop accurate predictive classifiers of these events.

Real-world Experiences in the Transplantation of Hepatitis C-NAAT-positive Organs.

Background: Hepatitis C virus (HCV) nucleic acid amplification test (NAAT)-positive donors have increased the organ pool. Direct-acting antivirals (DAAs) have led to high rates of treatment success and sustained virologic response (SVR) in recipients with donor-derived HCV infection without significant adverse effects, although variability remains in the timing and duration of antivirals. Methods: This retrospective study analyzed all adult HCV-NAAT-negative transplant recipients who received an organ from HCV-NAAT-positive donors from November 24, 2018, to March 31, 2022, at Duke University Medical Center with protocolized delay of DAA initiation until after hospital discharge, with at least 180-d follow-up on all patients. Transplant and HCV-related outcomes were analyzed. Results: Two hundred eleven transplants (111 kidneys, 41 livers, 34 hearts, and 25 lungs) were performed from HCV-NAAT-positive donors to HCV-NAAT-negative recipients. Ninety percent of recipients became viremic within 7 d posttransplant. Ninety-nine percent of recipients were initiated on pangenotypic DAAs in the outpatient setting a median of 52 d posttransplant, most commonly with 12-wk courses of sofosbuvir-velpatasvir (lungs) and glecaprevir-pibrentasvir (heart, kidney, and liver). Ninety-seven percent of recipients had SVR after a first-line DAA; all ultimately achieved SVR at 12 wk after subsequent treatment courses. The median peak HCV RNA for all organ systems was 2 436 512 IU/mL; the median time from antiviral to undetectable RNA was 48 d, although differences were noted between organ groups. No patient deaths or graft losses were directly attributable to HCV infection. Conclusions: One hundred percent of transplant recipients of HCV-NAAT-positive organs ultimately developed SVR without significant adverse effects when HCV antivirals were initiated in the outpatient setting after transplant hospitalization, suggesting that this real-world treatment pathway is a viable option.

Early versus delayed initiation of cytomegalovirus prophylaxis after liver transplant.

OBJECTIVES: Delaying cytomegalovirus (CMV) prophylaxis after liver transplantation may limit medication side effects and reduce inpatient drug costs. The primary objective of this study was to determine the incidence of CMV DNAemia in liver transplant recipients who initiated prophylaxis immediately after transplant (early prophylaxis) and those who initiated prophylaxis on postoperative day 7 or at discharge, whichever came first (delayed prophylaxis). STUDY DESIGN: This was a retrospective, single-center study of adult liver transplant recipients between February 2017 and February 2019. Patients who were at low risk for CMV (D-/R-), received dual organs, had a history of invasive CMV disease, or received prophylaxis with an agent other than ganciclovir/valganciclovir were excluded. Chart review of patient profiles was completed 9 months following the transplant, and the primary end point was the first positive CMV PCR within that timeframe. Cumulative incidence of CMV DNAemia was estimated by adjusting for competing events for early and delayed prophylaxis groups. The subdistribution hazard model was utilized to examine the effect of the timing of prophylaxis on CMV DNAemia while accounting for CMV serostatus. Secondary end points included peak quantifiable viral load, time to detection, and incidence of tissue-invasive disease. RESULTS: A total of 119 patients (60 early prophylaxis and 59 delayed prophylaxis) were included, and baseline demographics were similar except for sex. Twenty patients in the early group and 17 in the delayed group developed CMV DNAemia within 9 months of transplant with a cumulative incidence of 31.7% (95% confidence interval (CI) 20%, 44%) and 28.8% (95% CI 18%, 41%), respectively. After controlling for CMV serostatus, the relative incidence of DNAemia was similar between prophylaxis groups (subdistribution hazard ratio: 1.01, 95% CI 0.53, 1.90). CONCLUSIONS: No significant difference in CMV DNAemia within 9 months of liver transplant was observed between patients who received early and delayed prophylaxis. Future studies are warranted to conclude that delaying prophylaxis can be considered a safe alternative to initiating prophylaxis immediately after transplant.

Effects of Sofosbuvir-Based Hepatitis C Treatment Regimens on Calcineurin Inhibitor Dosing in Liver and Kidney Transplant Recipients.

OBJECTIVES: Available data have suggested that directacting antivirals for hepatitis C virus may decrease calcineurin inhibitor concentrations. In this study, our aim was to determine the effects of hepatitis C directacting antivirals on calcineurin inhibitor doses and trough levels. MATERIALS AND METHODS: This retrospective, singlecenter study included 52 abdominal transplant recipients treated with sofosbuvir-based regimens between 2014 and 2017. The primary outcome was percent change in calcineurin inhibitor troughs and total daily doses between the week before treatment with direct-acting antivirals, days 21 to 35 oftreatment, and days 21 to 35 aftertreatment. Secondary outcomes included sustained virologic response and biopsyproven acute rejection rates. RESULTS: The median percent difference in calcineurin inhibitor troughs from pretreatment to during treatment was -20.5% (interquartile range, -36.2% to 13.1%) and from pretreatment to posttreatment was -13.5% (interquartile range, -33.7% to 10.7%). Corresponding percent changes in calcineurin inhibitor doses were 0% (interquartile range, 0%-0%) and 0% (interquartile range, -10.5% to 33.3%), respectively. Patients on tacrolimus experienced statistically significant changes in troughs but not doses. During treatment, 65% of patients required no dose change, 23% underwent a dose increase, and 12% had a dose decrease. The sustained virologic response rate was 98%, and the biopsy-proven acute rejection rate was 0%. CONCLUSIONS: Hepatitis C direct-acting antiviraltherapy may decrease calcineurin inhibitor levels, but this was not associated with clinically different dosing requirements or rejection rates.

Clinical pharmacy programmatic perspectives on use of direct-acting antivirals for acquired hepatitis C infection in solid organ transplant recipients.

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.

Multi-disciplinary approach to perioperative risk assessment and post-transplant management for liver transplantation in a patient at risk for Brugada syndrome.

Brugada syndrome, an autosomal dominant genetic disorder, is characterised by abnormal electrocardiogram findings and increased risk of ventricular tachyarrhythmias and sudden cardiac death. Our report describes the multi-disciplinary perioperative management of a 28-year-old patient presenting to the Duke Transplant Center with a familial sodium channel gene SCN51 mutation concerning Brugada syndrome. We discuss the preparatory work-up, medication review and appropriate post-surgical follow-up for patients undergoing liver transplant surgery with cardiac monitoring.

Impact of Pharmacist Involvement in Early Identification and Enrollment in Patient Assistance Programs on CMV Outcomes in Transplantation.

BACKGROUND: No data exist evaluating the utilization of patient assistance programs (PAPs) on cytomegalovirus (CMV)-related outcomes. OBJECTIVE: To determine whether early identification and enrollment in PAPs can prevent CMV-related events. METHODS: Retrospective analysis of patients at risk of CMV reactivation who received kidney and/or pancreas transplants. Two groups were evaluated with patients receiving oral valganciclovir for CMV prophylaxis through enrollment in PAPs or oral acyclovir with preemptive CMV monitoring. Primary outcomes include the incidence of CMV infection. Secondary outcomes include a cost benefit analysis, incidence of rejection, patient/graft survival, and time to CMV infection. RESULTS: There were 97 patients identified; valganciclovir through PAPs (n = 39) and preemptive CMV quantitative nucleic acid testing monitoring (n = 58). The incidence of CMV viremia was lower in the PAP group (12.8% vs 36.2%, respectively; P = .021). There were no significant differences in CMV syndrome/disease, acute rejection, graft loss, or death between the groups. The time to CMV infection was shorter in the preemptive group. Cost benefit analysis found that hiring a full time pharmacy employee for enrolling patients in PAPs was cost beneficial for the institution/health care system. CONCLUSION: Early identification and enrollment of patients in PAPs reduces the incidence of CMV viremia. Pharmacists play a crucial role in this process.