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Post-Transplant Events

Validation of a DNAemia cutoff for preemptive therapy of cytomegalovirus infection in adult hematopoietic stem cell transplant recipients

Bone Marrow Transplantation volume 41, pages 873–879 (2008)Cite this article

Abstract

A randomized trial comparing a DNAemia cutoff of 10 000 copies per ml whole blood and first pp65 antigenemia positivity for initiation of preemptive therapy of human cytomegalovirus (HCMV) infection in adult hematopoietic stem cell transplant recipients was completed. DNAemia was chosen for cutoff definition since it is more automatable and standardizable than antigenemia, and more closely reflects the actual viral replication. The primary end point of the study was to compare the number of patients treated in the two arms. A total of 83 patients (42 in the DNAemia, and 41 in the antigenemia arm) were enrolled in the study. The incidence of HCMV infection, as detected by the relevant randomization assay (76% in the DNAemia versus 85% in the antigenemia arm), was comparable in the two arms, whereas the number of patients treated was significantly lower in the DNAemia arm (63 versus 80%, P=0.02). A single patient in the DNAemia arm suffered from biopsy-proven HCMV gastric disease diagnosed in the absence of detectable virus in blood. The incidence of graft-versus-host disease, and transplantation-related mortality did not differ between the two arms. In conclusion, our study shows that the use of a cutoff significantly reduces the number of patients requiring antiviral treatment, thus sparing unnecessary drug administration.

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Acknowledgements

We thank all the technical staff of the Servizio di Virologia for performing the assays, Daniela Sartori for preparing the paper and Laurene Kelly for revision of English. This work was partially supported by grants from the Ministero della Salute, Fondazione IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Policlinico San Matteo (Ricerca Corrente grant 80541, Ricerca Finalizzata 2003 grant 89269 and Fondazione Cariplo grant 93005).

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Authors and Affiliations

  1. Servizio di Virologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    G Gerna, D Lilleri & M Furione

  2. Unità Operativa di Trapianto, Clinica Ematologica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    D Caldera, L Zenone Bragotti & E P Alessandrino

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  1. G Gerna
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  2. D Lilleri
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  3. D Caldera
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  4. M Furione
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  5. L Zenone Bragotti
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  6. E P Alessandrino
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Correspondence to G Gerna.

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Gerna, G., Lilleri, D., Caldera, D. et al. Validation of a DNAemia cutoff for preemptive therapy of cytomegalovirus infection in adult hematopoietic stem cell transplant recipients. Bone Marrow Transplant 41, 873–879 (2008). https://doi.org/10.1038/sj.bmt.1705986

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