*Purpose: Evaluate efficacy and safety of a strategy utilizing high dose ganciclovir in kidney and pancreas transplant recipients requiring hospital admission for CMV infection.

*Methods: Adult kidney and pancreas transplant recipients admitted for CMV infection (4/29/19-7/15/20) received IV ganciclovir (10 mg/kg Q 12 hours x 7 days, renally adjusted) with step down to standard of care dosing thereafter (5 mg/kg Q12, renally adjusted). These patients were then compared to a standard of care (SOC) cohort admitted for CMV infection in a comparable time frame before implementation of the dosing strategy (10/20/16-3/2/19). Primary objective was response to the dosing strategy as measured by rate of viral clearance (delta log CMV) at day 7 of therapy. Secondary objectives were safety/toxicity as measured by leukopenia and short term (90 day) efficacy outcomes.

*Results: 54 patients met inclusion criteria; 22 in the high dose cohort, 32 in the SOC cohort. Clinical characteristics were similar in the two groups, including induction type at transplant and degree of immunosuppressive modification in response to CMV diagnosis (Table). Patients who received the high-dose strategy had a significantly greater response to therapy at day 7 compared to the SOC cohort (high dose -0.92 log vs SOC -0.56 log, p=0.04). Change in WBC at day 7 was not different between groups (high-dose -0.49 vs SOC -0.45). Despite significantly more rapid clearance kinetics at day 7, the intensified dosing strategy was not associated with reduction in hospital length of stay (10.9 days high-dose vs 9.5 days SOC, p=0.52), 30 and 90 day all-cause readmission rates (30d: 4.5% high-dose vs 15.6% SOC, p=0.38, 90d: 13.6% high-dose vs 21.9% SOC, p=0.5) or clearance of viremia by day 90, as defined as achievement of CMV viral load less than lower limit of quantification (73% high-dose, 84% SOC, p=0.06).

*Conclusions: A high dose strategy of IV GCV results in increased viral clearance kinetics without additional leukopenia at day 7 but does not significantly affect hospital length of stay, hospital readmission or viral clearance to

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