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Key Points 1. Our increasing understanding of signaling pathways and cellular interactions in transplant immunobiology and the availability of novel immunosuppressive agents have facilitated targeted strategies. 2. The driving forces behind the development of new immunosuppressive regimens are the long-term complications of current immunosuppressive regimens (particularly renal dysfunction and metabolic disturbances). 3. By regulatory mandate, the requirement for the primary endpoint to be a composite of death, graft loss, and rejection remains intact; however, current and future clinical trials could incorporate key secondary endpoints that address renal and metabolic derangements. Liver Transpl, 2011. © 2011 AASLD.

Background There is a demand for stewardship implementation and research in ambulatory and SOT populations. Few studies focus on outpatient stewardship interventions, and none has focused on timely recognition of CMV in outpatient SOT recipients. This study sought to determine the effect of real-time CMV result notification paired with pharmacist intervention on virologic and clinical outcomes in outpatient SOT recipients. Methods Quasi-experimental study comprised of two 6-month phases. In the pre-intervention phase, pharmacists were not involved in management of outpatient CMV viremia. In the intervention phase, pharmacists received real-time email notification of positive blood CMV results for review and intervention as necessary. The primary endpoint was rate of viremia eradication at 21 days from therapy initiation. Secondary endpoints: time to antiviral initiation and viremia eradication, rate of CMV invasive disease and hospital admission, and adverse drug events. Results 88 of 213 screened patients were included in the primary analysis (n = 49 and 39 in the pre-intervention and intervention groups, respectively). Baseline characteristics were similar, including transplant type (34% vs. 41% liver, 24% vs. 28% kidney, 14% vs. 17% lung, 14% vs. 10% heart), CMV serostatus (53% vs. 64% D+/R-), and maintenance immunosuppression. A total of 73 recommendations were made with 89% acceptance. Baseline CMV viral load >10,000 IU/mL occurred in 12 (24%) vs. 6 (15%) patients (P = 0.29). Of treated patients, 42 (85%) vs. 32 (82%) achieved CMV eradication at 21 days (P = 0.64), 10 (20%) vs. 5 (12%) required admission for CMV management (P = 0.35), 7 (14%) vs. 3 (7%) developed CMV invasive disease (P = 0.50), and 29 (60%) vs. 25 (66%) received antiviral within 5 days (P = 0.61). There were no statistically significant differences in time to antiviral initiation (45 vs. 41 hours; P = 0.64) or viremia eradication (19 vs. 18 days; P = 0.44). Conclusion CMV eradication at 21 days was not significantly different between groups; however, fewer patients in the intervention experienced elevated baseline viral load, CMV invasive disease, and hospital admission. These secondary endpoints suggest possible benefit from the intervention and warrant further characterization and study. Disclosures All authors: No reported disclosures.

Purpose The stability of diluted adenosine solutions in polyvinyl chloride infusion bags was studied. Methods Adenosine 50-, 100-, and 220-μg/mL solutions were prepared in 50-mL polyvinyl chloride (PVC) infusion bags containing 0.9% sodium chloride injection or 5% dextrose injection and stored at room temperature (23–25 °C) or under refrigeration (2–8 °C). Each sample of every combination of concentration, diluent, and storage temperature was prepared in triplicate, yielding 36 samples. The samples were assayed using a stability-indicating, reverse-phase high-performance liquid chromatographic method immediately after preparation (time zero) and at 24 hours, 48 hours, 7 days, and 14 days. pH was measured at time zero, 48 hours, 7 days, and 14 days. Time zero concentrations were calculated from the equation produced from a calibration curve of standards ranging from 10 to 500 μg/mL. Samples were also visually inspected against a light background for clarity, color, and the presence of crystalline particulate matter. Stability was defined as retaining at least 90% of the initial adenosine concentration. Results After 14 days, all samples retained greater than 98% of the initial adenosine concentration, with no evidence of adsorption, visible precipitation, or considerable change in pH, suggesting minimal to no loss of product due to degradation or adsorption. Conclusion Adenosine 50-, 100-, and 220-μg/mL solutions in 50-mL PVC infusion bags containing 0.9% sodium chloride injection or 5% dextrose injection stored at room temperature and refrigerated conditions were stable for at least 14 days.