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Prepublished online as a Blood First Edition Paper on February 13, 2003; DOI 10.1182/blood-2002-12-3636.
Submitted December 4, 2002
Accepted February 3, 2003
Human cytomegalovirus immediate early-mRNAemia vs pp65-antigenemia for guiding pre-emptive therapy in children and young adults given hematopoietic stem cell transplantation: a prospective, randomized, open-label trial
Giuseppe Gerna*, Daniele Lilleri, Fausto Baldanti, Maria Torsellini, Giovanna Giorgiani, Marco Zecca, Pietro De Stefano, Jaap Middeldorp, Franco Locatelli, and Maria Grazia Revello
Servizio di Virologia, IRCCS Policlinico San Matteo, Pavia, Italy
Istituto di Clinica delle Malattie Infettive, Universita' degli Studi di Pavia, Pavia, Italy
Oncoematologia Pediatrica, IRCCS Policlinico San Matteo, Pavia, Italy
Department of Pathology, VU Medical Center, Free University of Amsterdam, Amsterdam, The Netherlands
* Corresponding author; email: g.gerna{at}smatteo.pv.it.
In the search for better protocols of pre-emptive therapy of human cytomegalovirus (HCMV) infection in hematopoietic stem cell transplant (HSCT) recipients, we conducted a randomized trial comparing antigenemia with the nucleic acid sequence-based assay (NASBA) for determination of HCMV immediate-early messenger RNA (IEmRNA) as the guiding assay for initiation of pre-emptive antiviral treatment. In the IEmRNA arm, antiviral therapy was started upon IEmRNA positivity confirmed the following day, whereas, in the antigenemia arm, therapy was started in the presence of either  2 pp65-positive leukocytes/2x105 examined or a single positive leukocyte confirmed the following day. In both arms, treatment was stopped upon two consecutive negative results. All patients were monitored for 3 months after HSCT. Primary endpoint of the study was duration of anti-HCMV therapy. On the whole, 80 children (41 in the IEmRNA, and 39 in the antigenemia arm), transplanted from either a relative or an unrelated donor, completed the study. No patient developed HCMV disease. In the IEmRNA arm, the incidence of HCMV infection was higher compared to the antigenemia arm (80% vs. 51%, respectively, p=0.0069), as well as the percentage of treated patients (66% vs. 44%, respectively, p=0.045). However, the percentage of relapses and treated relapses was comparable in the two arms. There was no significant difference in median duration of therapy per patient. Although these data indicate that IEmRNA determination does not offer advantages in terms of treatment duration, it can safely replace antigenemia, while semiautomation is the major advantage of the NASBA procedure.
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