Conversion to Sirolimus to Prevent Recurrent Cytomegalovirus Infection/Disease: A Prospective and Randomized Trial
Hospital do Rim - UNIFESP, São Paulo, Brazil
Meeting: 2020 American Transplant Congress
Abstract number: 378
Keywords: Cytomeglovirus, Kidney transplantation, Mycophenolate mofetil, Sirolimus (SLR)
Session Information
Session Name: CMV and other Herpes Viruses
Session Type: Oral Abstract Session
Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:45pm
Presentation Time: 3:39pm-3:51pm
Location: Virtual
*Purpose: Recurrent cytomegalovirus (CMV) infection occurs in 30-35% of kidney transplant recipients after completion of treatment and/or preemptive therapy. There is no consensus on the ideal strategy to manage these patients. While the use of mTOR inhibitors is associated with lower incidence of first episode of CMV infection, its efficacy/safety for the prevention of CMV recurrence is unknown. The pourpose of this study was to investigate whether a conversion to sirolimus after the first episode of CMV infection/disease is associated with reduced incidence of recurrent CMV infection.
*Methods: This proof of concept prospective trial (NCT02671318) included low immunological risk CMV positive kidney transplant recipients receiving a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, antiproliferative (azathioprine or mycophenolate), and prednisone. Right after completion of the treatment of the first episode of CMV infection/disease patients were randomized to be converted (SRL) or not (CTR) from the antiproliferative to sirolimus. No CMV pharmacological prophylaxis was used. A sample size of 72 patients was calculated to demonstrate a 75% reduction in the incidence of recurrent CMV infection (80% power, 95% confidence level).
*Results: We randomized 72 patients (35 SRL and 37 CTR) at a median post transplant time of 66 (IQR 60-82) days. In the SRL group there were no episodes of recurrent CMV infection compared to 14 patients in CTR group (0% vs. 37.8%, [0.280.390.54 95% CI], p<0.001). Two patients in the CTR group presented 3 or more recurrent CMV infection episodes. There were no differences in the incidence of acute rejection after conversion (11.4% vs. 10.8%, p=0.934), drug discontinuation (20% vs. 16%, p=0.66), renal function (50.0 [IQR 22.2] vs. 56.1 [IQR 34.5] ml/min, p=0.105), and graft (97.1% vs. 100%, p=0.486) and patient (97.3% vs. 91.4%, p=0.350) survival at 12 months.
*Conclusions: These data suggest that conversion from antiproliferative to sirolimus after the first episode of CMV infection/disease is an effective and safe strategy for the prevention of recurrent CMV infection after kidney transplantation.
To cite this abstract in AMA style:
Viana LAlmeida, Cristelli MPontello, Basso G, Dantas MTaverCosta, Dreige YCardoso, Damasceno L, Nakamura MRika, Tedesco-Silva H, Medina-Pestana J. Conversion to Sirolimus to Prevent Recurrent Cytomegalovirus Infection/Disease: A Prospective and Randomized Trial [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/conversion-to-sirolimus-to-prevent-recurrent-cytomegalovirus-infection-disease-a-prospective-and-randomized-trial/. Accessed May 16, 2025.« Back to 2020 American Transplant Congress