Session Name: All Infections (Excluding Kidney & Viral Hepatitis)
Session Date & Time: None. Available on demand.
*Purpose: Assess the impact of tacrolimus-sirolimus (TAC/SRL) concentration on infection rate in heart transplant recipients (HTR).
*Methods: A retrospective review of HTR on TAC/SRL for ≥ 1 year from 01/2006-08/2019 was conducted. Drug concentrations were defined as high (≥ 15 ng/mL) or low (< 15 ng/mL), calculated as the summation of individual medication’s annual average concentration for every year of therapy. For patients on TAC/SRL for > 1 year, each year of therapy was considered its own discrete case. The primary outcome was median rate of infection, defined as positive culture or other documented clinical finding treated with a full course of antimicrobial. Secondary outcomes included the incidence of any, bacterial, viral, and fungal infections as well as acute rejection, defined as clinically evident cellular rejection (Grade 0R, 1R, 2R or 3R) treated with high-dose corticosteroids.
*Results: A total of 60 individual case years were analyzed from 22 patients. There were 21 vs 39 cases in the high and low TAC/SRL groups, respectively. The average TAC/SRL concentration was 18.5 ± 2.5 ng/mL in the high and 13.0 ± 1.3 ng/mL in the low group. Median infection rates were significantly greater in the high vs low TAC/SRL group (2 vs 0, p<0.0001). The incidence of any infection, bacterial infections and acute rejection were significantly greater in the high vs low group (Table 1). There were no cases of antibody mediated rejection in either group.
|High TAC/SRL (n=21)||Low TAC/SRL (n=39)||P-value|
|Rate of infection, median (IQR)*||2 (1-2)||0 (0-1)||P<0.0001|
|Any infection incidence, n (%)||18 (86)||17 (44)||0.002|
|Bacterial infection incidence, n (%)||18 (86)||15 (38)||P<0.0001|
|Viral infection incidence, n (%)||5 (24)||4 (10)||0.164|
|Fungal infection incidence, n (%)||1 (5)||2 (5)||0.984|
|Acute rejection incidence, n (%)||14 (67)||9 (23)||0.001|
|*Some case years had ≥ 1 recorded infection|
*Conclusions: Higher combined concentrations of TAC/SRL in HTR were associated with increased infections per year. Targeting TAC/SRL concentrations of < 15 ng/mL is reasonable to decrease the risk of infection, however the risk of rejection should be considered. Given the retrospective nature of the study, it is unknown if target concentrations were increased before or after a rejection episode was experienced. Prospective studies are warranted to confirm findings and to further assess the association of combined TAC/SRL concentrations on allograft rejection.
To cite this abstract in AMA style:Goyal S, Lyons J, Negrelli J, Liebo M, Heroux A. Infection Rates in Heart Transplant Recipients With Combined Tacrolimus and Sirolimus at High versus Low Concentrations [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/infection-rates-in-heart-transplant-recipients-with-combined-tacrolimus-and-sirolimus-at-high-versus-low-concentrations/. Accessed June 12, 2021.
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