Cytomegalovirus PP65 antigen-guided preemptive therapy with ganciclovir insolid organ transplant recipients: A prospective, double-blind, placebo-controlled study

Background. The aim of this study was to evaluate pp65 antigen-guided antiv iral therapy in preventing human cytomegalovirus (HCMV) infection in solid organ transplant recipients. Methods. Ten kidney and two liver transplant recipients with asymptomatic H CMV infection were randomized either for i.v. ganciclovir or placebo treatm ent in a prospective, double-blind study. All patients were positive by HCM V pp65 antigen test at levels >5 positive cells/2 x 10(5) investigated cell s. Results. No cases of HCMV end-organ disease occurred. In contrast to patien ts on placebo (5/7), none of the patients on ganciclovir (0/5) developed HC MV-associated symptoms (P=0.01). However, because of the small number of pa tients, all three high-risk patients (donor seropositive, recipient seroneg ative) were randomized to placebo and all three developed symptoms. Conclusions. Preemptive antiviral therapy guided by the pp65 antigen test s eems to have a beneficial effect on preventing HCMV-associated symptoms in kidney and liver transplant recipients.