{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T02:55:07Z","timestamp":1791860107632,"version":"4.3.4"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Merck Sharp & Dohme LLC"},{"DOI":"10.13039\/100004334","name":"Merck & Co., Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>QuantiFERON-cytomegalovirus (QFT-CMV) is a standardized assay for the evaluation of cytomegalovirus-specific cell-mediated immunity (CMV-CMI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The purpose of this study was to assess the evolution of CMV-CMI posttransplant and the clinical utility of QFT-CMV for the prediction of postprophylaxis CMV disease in CMV-seronegative recipients of CMV-seropositive donor kidneys (D+R\u2212 KTRs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>601 adult CMV D+R\u2212 kidney transplant recipients (KTRs) received letermovir or valganciclovir prophylaxis for 28 weeks in a phase 3, double-blind, multicenter trial (ClinicalTrials.gov NCT03443869). QFT-CMV was performed at a central laboratory by masked personnel at transplant, 12, 28, and 52 weeks posttransplant. Investigators assessed CMV disease through week 52. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) at week 28 were used to evaluate the clinical utility of QFT-CMV.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Positive QFT-CMV results (pooled) were detected: baseline\u20131.2%, week 12\u20132.6%, week 28\u20137.7%, and week 52\u201328.9%. The distribution of positive results with letermovir and valganciclovir was comparable, except at week 28 (letermovir 2.2% and valganciclovir 12.8%). Postprophylaxis CMV disease by week 52 occurred in 18.3% (84\/460) of evaluable participants: 12.5% (4\/32) of participants with a positive, 17.5% (66\/377) with a negative, and 27.5% (14\/51) with an indeterminate result at week 28 (p = not significant for all comparisons). QFT-CMV sensitivity, specificity, PPV, and NPV were 8.3%, 94.3%, 87.5%, and 17.5%, and were similar when pooling indeterminate and negative results and within the letermovir and valganciclovir study arms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Among adult CMV high-risk D+R\u2212 KTRs who received prophylaxis, CMV-CMI by QFT-CMV increased over time. The result at the end of prophylaxis had limited clinical utility for identifying the risk for subsequent CMV disease.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf632","type":"journal-article","created":{"date-parts":[[2025,11,18]],"date-time":"2025-11-18T12:47:45Z","timestamp":1763470065000},"page":"e316-e324","source":"Crossref","is-referenced-by-count":5,"title":["Cytomegalovirus (CMV)-Specific Cell-Mediated Immunity for Prediction of Postprophylaxis CMV Disease in a Phase 3 Trial of Letermovir Versus Valganciclovir Prophylaxis in Donor CMV-Seropositive\/Recipient CMV-Seronegative Kidney Transplant Recipients"],"prefix":"10.1093","volume":"82","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5350-9025","authenticated-orcid":false,"given":"Ajit P","family":"Limaye","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Transplant and Immunocompromised Host Infectious Disease Program, University of California, San Francisco, San Francisco , California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6992-6379","authenticated-orcid":false,"given":"Marta","family":"Crespo","sequence":"additional","affiliation":[{"name":"Nephrology Department and Kidney Transplant Unit, Hospital del Mar, Nephropathy Research Group, Hospital del Mar Research Institute, Universitat Pompeu Fabra , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1930-8964","authenticated-orcid":false,"given":"Nassim","family":"Kamar","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Organ Transplantation, Toulouse Rangueil University Hospital, INSERM UMR 1291, Toulouse Institute for Infectious and Inflammatory Diseases (Infinity), Paul Sabatier University , Toulouse ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1751-7159","authenticated-orcid":false,"given":"Atul","family":"Humar","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Ajmera Transplant Center, University Health Network, University of Toronto , Toronto, Ontario ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6238-026X","authenticated-orcid":false,"given":"Robert P","family":"Carroll","sequence":"additional","affiliation":[{"name":"Transplantation Immunogenetics Service , LifeBlood, Adelaide, South Australia ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9214-9122","authenticated-orcid":false,"given":"Marcus R","family":"Pereira","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Department of Medicine, Columbia University College of Physicians and Surgeons , New York, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1512-2838","authenticated-orcid":false,"given":"Natalya","family":"Broyde","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiwen","family":"Wang","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Haber","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, Merck & Co., Inc. , Rahway, New Jersey 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