CYTOMEGALOVIRUS INFECTION IN PEDIATRIC KIDNEY TRANSPLANT RECIPIENTS RECEIVING CYTOMEGALOVIRUS PROPHYLAXIS: A SYSTEMATIC LITERATURE REVIEW
Author(s)
Lan Jin, PhD1, Nazleen Khan, ScD1, Jitender Takyar, MPharm2, Arju Dhawan, MPharm2, Rakesh Thode, MPharm3, Neha Santosh Kumar, MPharm2, Barbara Haber, MD1.
1Merck & Co., Inc., Rahway, NJ, USA, 2Parexel International, Mohali, India, 3Parexel International, Hyderabad, India.
1Merck & Co., Inc., Rahway, NJ, USA, 2Parexel International, Mohali, India, 3Parexel International, Hyderabad, India.
OBJECTIVES: Cytomegalovirus (CMV) remains a leading infectious complication in pediatric kidney transplant (KT) recipients despite existing prophylactic strategies. This systematic literature review evaluated the incidence and risk factors of CMV infection, disease, and syndrome among pediatric KT recipients receiving CMV prophylaxis.
METHODS: A systematic search of Embase®, MEDLINE®, PubMed, the Cochrane Library, and relevant conference proceedings (January 2017-2026) identified studies reporting CMV outcomes in pediatric transplant recipients receiving prophylaxis. Eligible studies included pediatric KT recipients receiving CMV prophylaxis with post-transplant CMV infection, disease, or syndrome outcomes. Due to heterogeneity in study design, definitions, and reporting, findings were synthesized descriptively.
RESULTS: Of 2,511 records screened, 31 studies were included (22 kidney-specific; 9 mixed solid-organ cohorts including KT recipients). Eighteen and 13 studies used universal prophylaxis and risk stratification strategies, respectively. Reported CMV incidence varied substantially: infection ranged from 3.7%-53.6% (31 studies), disease from 0%-10.7% (12 studies), and syndrome from 0%-9.8% (7 studies). Across 10 studies reporting donor-recipient serostatus subgroups, high-risk (D+/R−) and intermediate-risk (R+) recipients consistently had higher CMV infection rates (8.7%-63.6%) than low-risk (D−/R−) patients (0%-25%) in each study. Among the eight studies evaluating the risk factors, two studies reported a significant association between shorter prophylaxis duration and increased incidence of CMV DNAemia: one study showing higher risk associated with prophylaxis for <150 days, compared to 180 ± 30 days (odds ratio=8.33; p=0.01) and another study showing ~80% of patients with DNAemia had short prophylaxis (≤6 months) compared to 60% without DNAemia (p=0.044). Other factors—including immunosuppression intensity (5/8 studies), sex (3/8), HLA mismatch (2/8), and ethnicity (1/8)—showed inconsistent associations.
CONCLUSIONS: CMV infection following prophylaxis in pediatric KT recipients remains substantial and highly variable. Donor-recipient serostatus is the most consistently identified risk factor, while evidence for other predictors, including prophylaxis duration, remains limited and heterogeneous.
METHODS: A systematic search of Embase®, MEDLINE®, PubMed, the Cochrane Library, and relevant conference proceedings (January 2017-2026) identified studies reporting CMV outcomes in pediatric transplant recipients receiving prophylaxis. Eligible studies included pediatric KT recipients receiving CMV prophylaxis with post-transplant CMV infection, disease, or syndrome outcomes. Due to heterogeneity in study design, definitions, and reporting, findings were synthesized descriptively.
RESULTS: Of 2,511 records screened, 31 studies were included (22 kidney-specific; 9 mixed solid-organ cohorts including KT recipients). Eighteen and 13 studies used universal prophylaxis and risk stratification strategies, respectively. Reported CMV incidence varied substantially: infection ranged from 3.7%-53.6% (31 studies), disease from 0%-10.7% (12 studies), and syndrome from 0%-9.8% (7 studies). Across 10 studies reporting donor-recipient serostatus subgroups, high-risk (D+/R−) and intermediate-risk (R+) recipients consistently had higher CMV infection rates (8.7%-63.6%) than low-risk (D−/R−) patients (0%-25%) in each study. Among the eight studies evaluating the risk factors, two studies reported a significant association between shorter prophylaxis duration and increased incidence of CMV DNAemia: one study showing higher risk associated with prophylaxis for <150 days, compared to 180 ± 30 days (odds ratio=8.33; p=0.01) and another study showing ~80% of patients with DNAemia had short prophylaxis (≤6 months) compared to 60% without DNAemia (p=0.044). Other factors—including immunosuppression intensity (5/8 studies), sex (3/8), HLA mismatch (2/8), and ethnicity (1/8)—showed inconsistent associations.
CONCLUSIONS: CMV infection following prophylaxis in pediatric KT recipients remains substantial and highly variable. Donor-recipient serostatus is the most consistently identified risk factor, while evidence for other predictors, including prophylaxis duration, remains limited and heterogeneous.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH119
Topic
Epidemiology & Public Health
Disease
Infectious Disease (non-vaccine)