Effect of prophylactic ganciclovir on cytomegalovirus infection in renal transplant recipients

Cytomegalovirus (CMV) infection is the most frequent infectiouscomplication observed in renal transplant recipients and inducesa significant morbidity in these patients due to CMV diseaseitself and to associated renal dysfunction or opportunisticsuperinfection. In order to evaluate the effect of ganciclovirprophylaxis we conducted an open-label prospective randomizedstudy of ganciclovir administration in CMV seronegative recipientsof a renal allograft from CMV seropositive donors. Ganciclovir(5 mg/kg b.i.d./day for 14 days) was started on day 14 aftertransplantation. Thirty-two patients were included in this study(15 in the control group, 17 in the ganciclovir group). Therewas no significant difference between the two groups for age,immunosuppressive regimen, number of rejection, steroid pulses,and OKT3 treatments. Renal and patient outcomes were similarin both groups. The rate of CMV infection and CMV disease weresimilar in both groups (80% and 73.3% in the control group versus70.6% and 47.1% in the ganciclovir group; P=NS). Less severeCMV disease was observed in the ganciclovir group compared tocontrols. The delay between transplantation and CMV infectionwas significantly longer in the ganciclovir group compared tocontrol group (68.1±5.1 versus 44.0±5.2 days,P<0.005). Twelve control patients (80%) versus nine (53%)of the ganciclovir group required curative treatment with ganciclovirafter the diagnosis of CMV infection (NS). All the patientsrecovered from CMV disease and no significant side-effect wasobserved during ganciclovir administration. We conclude that prophylactic ganciclovir administration fromday 14 to day 28 after transplantation does not prevent CMVinfection in seronegative recipients of renal allograft fromseropositive donors but prolongs the incubation period. Longerprophylaxis by ganciclovir in these patients should be tested.