Prophylaxis followed by preemptive therapy versus preemptive therapy for prevention of human cytomegalovirus disease in pediatric patients undergoing liver transplantation.
Twenty-one pediatric liver transplant recipients were enrolled in a study comparing prophylaxis followed by preemptive therapy (10 patients) versus preemptive therapy alone (11 patients) for prevention of human cytomegalovirus (HCMV) disease. In the prophylaxis arm, patients were treated with ganciclovir for 30 days, then preemptive therapy was initiated with virologic monitoring for pp65 antigenemia. In the preemptive therapy arm, patients were treated on reaching 100,000 DNA copies/mL whole blood. An interim analysis showed that, although numbers of both infected and treated patients were comparable in the two arms, the median number of total days of antiviral therapy per patient (30 vs. 18, P<0.01) was significantly higher in the prophylaxis arm. No case of HCMV disease occurred in either arm. Therefore, the trial was interrupted and prophylaxis replaced with preemptive therapy alone. In parallel, the development of T-cell-mediated immune response was found to be comparable in both arms.
Gerna
Giuseppe
G
Servizio di Virologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. g.gerna@smatteo.pv.it
Lilleri
Daniele
D
Callegaro
Annapaola
A
Goglio
Antonio
A
Cortese
Serena
S
Stroppa
Paola
P
Torre
Giuliano
G
D000956:Antigens, Viral / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003587:Cytomegalovirus / Q000235:genetics / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000209:etiology / Q000276:immunology / Q000517:prevention & control*; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D015774:Ganciclovir / Q000008:administration & dosage*; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects; D007223:Infant; D016031:Liver Transplantation / Q000009:adverse effects*; D010750:Phosphoproteins / Q000097:blood; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D016896:Treatment Outcome; D014763:Viral Matrix Proteins / Q000097:blood
D000956:Antigens, Viral; D000998:Antiviral Agents; D004279:DNA, Viral; D010750:Phosphoproteins; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa; D015774:Ganciclovir