Use of a DNAemia cut-off for monitoring human cytomegalovirus infection reduces the number of preemptively treated children and young adults receiving hematopoietic stem-cell transplantation compared with qualitative pp65 antigenemia.

We performed a randomized trial comparing the use of quantitative DNAemia versus positive antigenemia for starting preemptive antihuman cytomegalovirus (HCMV) therapy in hematopoietic stem-cell transplantation (HSCT) recipients. In the DNAemia arm, antiviral therapy was initiated on reaching a DNAemia cut-off of 10 000 DNA copies/mL of whole blood, whereas in the antigenemia arm, therapy was started in the presence of a positive antigenemia. The aim of the study was to compare the number of patients treated in the 2 arms. On the whole, 178 patients (89 in each arm), receiving unmanipulated HSCT from either a relative or an unrelated donor, completed the study. Although the incidence of HCMV infection was comparable in DNAemia and antigenemia arms (34% vs 42%, respectively, P = .259), the number of patients treated was significantly lower in the DNAemia arm (18% vs 31%, P = .026). No patient developed HCMV disease. The use of a DNAemia cut-off avoids unnecessary antiviral treatment.

RCT Entities:   Population Interventions Outcomes