INCIDENCE OF CYTOMEGALOVIRUS INFECTION OR DISEASE USING VALGANCICLOVIR PROPHYLAXIS OR PREEMPTIVE THERAPY IN LIVING-DONOR KIDNEY TRANSPLANT RECIPIENTS AT INTERMEDIATE RISK FOR CMV ON BASILIXIMAB-BASED REGIMEN

 

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https://storage.unitedwebnetwork.com/files/1099/d6ae613ebc86d4d5ba5db312a9fa7eef.pdf
INCIDENCE OF CYTOMEGALOVIRUS INFECTION OR DISEASE USING VALGANCICLOVIR PROPHYLAXIS OR PREEMPTIVE THERAPY IN LIVING-DONOR KIDNEY TRANSPLANT RECIPIENTS AT INTERMEDIATE RISK FOR CMV ON BASILIXIMAB-BASED REGIMEN

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Claudia
Rojas
Claudia Rojas claudiarojtapia@gmail.com Instituto Mexicano del Seguro Social Nefrologia y trasplante renal Guadalajara Mexico *
Alicia Palacios claudiarojtapia@gmail.com Instituto Mexicano del Seguro Social Nefrologia y trasplante renal Guadalajara Mexico -
Jorge Andrade claudiarojtapia@gmail.com Instituto Mexicano del Seguro Social Nefrologia y trasplante renal Guadalajara Mexico -
Celeste Monroy claudiarojtapia@gmail.com Instituto Mexicano del Seguro Social Nefrologia y trasplante renal Guadalajara Mexico -
Luis Evangelista claudiarojtapia@gmail.com Instituto Mexicano del Seguro Social Nefrologia y trasplante renal Guadalajara Mexico -
Ignacio Cerrillos claudiarojtapia@gmail.com Instituto Mexicano del Seguro Social Nefrologia y trasplante renal Guadalajara Mexico -
 
 
 
 
 
 
 
 
 

Prevention of cytomegalovirus (CMV) infection in kidney transplant recipients (KTRs) is essential in post-transplant management, as it negatively affects graft function and patient survival. CMV infection is also linked to indirect effects such as graft dysfunction, acute T cellmediated rejection (AR), and increased susceptibility to other opportunistic infections. Current preventive strategies include universal prophylaxis with valganciclovir (VGC) or preemptive therapy (PT) based on PCR monitoring, both effective but debated in their optimal use, especially in intermediate-risk patients (R+/D+ or R+/D−) receiving basiliximab (BSL), where efficacy, safety, and cost must be balanced.

Between March 1, 2024, and July 31, 2025, an open-label, randomized, single-center clinical trial was conducted with a 12-month follow-up, including 52 living-related KTRs. Participants were assigned 1:1 using a random number table. Group 1 (control) received antiviral prophylaxis with VGC, while Group 2 was managed with a PT strategy. Both groups received BSL-based induction immunosuppression. In the PT group, quantitative serum CMV PCR was performed every 15 days for the first 3 months; afterward, both groups underwent monthly monitoring through month 12. Clinical, biochemical, and virological data were collected at each visit, along with adverse events, CMV infection, CMV disease, hematological changes, and AR episodes.

Five CMV infections were recorded during follow-up (9.6% overall): two cases (8%) in the PT group and three (12%) in the prophylaxis group. The difference was not significant (χ²=0.222, p=0.64; HR=0.68,95% CI0.097–4.1),indicating PT did not increase CMV risk. No significant biochemical differences were observed at baseline or follow-up, and viremia episodes were transient, without clinical deterioration or progression to CMV disease. Adverse events and graft-related complications were comparable between groups

Both universal VGC prophylaxis and PCR-guided PT were safe and effective for CMV prevention in intermediate-risk living-donor KTRs. No significant differences were found in infection incidence, CMV-free survival, or clinical outcomes. These results support adapting preventive strategies to available resources and diagnostic capacity. In settings with reliable virological monitoring, PT may be a cost-effective alternative, reducing unnecessary antiviral exposure without compromising efficacy.

Kewords