*Purpose: Cytomegalovirus (CMV) is associated with significant mortality and morbidity in kidney transplant recipients (KTRs). Various CMV anti-viral (AV) preventive strategies have been utilized in KTRs, however, a recent systematic review has not been performed summarizing up-to-date information on this topic. Therefore, we examined efficacy, safety and costs of CMV-AV prevention strategies in KTRs using a systematic literature review (SLR) of randomized controlled trials (RCTs).

*Methods: MEDLINE and Embase (from inception to November 2018) were searched to identify RCTs examining outcomes of CMV prevention strategies in adult KTRs.

*Results: Of 1,860 retrieved citations, 30 RCTs met inclusion criteria. Included RCTs varied in terms of defining and assessing timepoints for outcomes, dose and duration of AV use. Out of 12 studies comparing prophylaxis (PROPH) vs. NO PROPH, PROPH had significantly lower rates of CMV infection (CMVi) (6 studies), CMV syndrome/disease (CMVsd) (6 studies), and lower mean duration of post-transplant length of stay (LOS) (1 study). Out of 4 studies comparing preemptive (PET) vs. NO PET, PET had lower rates of CMVsd (3 studies), and long-term medical care costs (1 study). Of 5 studies comparing PROPH vs. PET, PROPH had significant lower rates of early CMVi (4 studies) and CMVsd (2 studies) and higher rates of late CMVi (2 studies), and hematological toxicities (2 studies); PROPH had higher drug costs but lower CMV testing costs and similar overall medical costs (2 studies). Of 9 RCTs comparing different PROPH strategies, oral ganciclovir (OGC) showed a lower CMVisd compared to acyclovir (1 study) and had similar rates of CMVisd to valacyclovir/valganciclovir. OGC had similar rates of CMVi but lower incidence of CMVsd compared with IVGC (1 study). Valganciclovir (VGC) PROPH for 6-month (6M) reduced CMVisd compared to VGC for 3M, however, the 6M VGC had a higher rate of hematological toxicity (1 study). VGC 6M high dose vs. low dose had a similar rate of CMVsd, but a higher rate of hematological toxicity (1 study).

*Conclusions: Although there was heterogeneity across population and interventions, both PROPH and PET strategies reduced CMV infection/disease compared to no PROPH/PET and had differential safety profile in terms of hematological toxicities. Despite demonstrated efficacy of PROPH/PET, our findings highlight the potential need of a novel intervention with a better safety profile and perhaps improved outcomes.

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