Valganciclovir preemptive therapy for the prevention of cytomegalovirus disease in high-risk seropositive solid-organ transplant recipients

Background. The role of valganciclovir in the prevention of cytomegalovirus (CMV) disease in high-risk seropositive transplant patients is not known. Methods. We prospectively followed 301 seropositive solid organ transplant recipients to assess the efficacy and safety of valganciclovir (VGCV) in the prevention of CMV disease in high-risk patients. Asymptomatic patients with an antigenemia test >= 25 positive cells/2 x 10(5) polymorphonuclear cells received valganciclovir 900 mg twice a day as preemptive therapy until resolution of antigenemia (minimum 14 days). Additionally, patients treated with antilymphocytic drugs for more than 6 days received prophylaxis with VGCV 900 mg once a day during 90 days. Mean follow-up was 14 months (range 6-20 months). Results. Thirty-eight patients received VGCV; 24 as preemptive therapy and 14 due to the use of antilymphocytic drugs. No patient developed CMV disease during the follow-up. Viral load (antigenemia) decreased a mean of 78% from baseline after 7 days of VGCV therapy (P = 0.024) and 98% at day 14 (P = 0.029). Two patients showed a relapse of the antigenemia. test 25 positive cells and were successfully treated with a repeated course of VGCV. Leukopenia (< 2500/mm(3)) developed in 3/24 (12.5%) recipients in the preemptive therapy group and required to discontinuing the drug in one of them. Conclusions. VGCV is safe and highly efficacious in the prevention of CMV disease in high-risk seropositive organ transplant recipients.