• Oscar Len, Joan Gavaldà, José María Aguado, Núria Borrell, Carlos Cervera, José Miguel Cisneros, Valentín Cuervas-Mons, Mercè Gurguí, Pilar Martin-Dávila, Miguel Montejo, Patricia Muñoz, Germán Bou, Jordi Carratalà, Julián Torre-Cisneros, Albert Pahissa, and RESITRA.
• Spanish Network for Research on Infection in Transplantation, Spain. olen@ir.vhebron.net
• Clin. Infect. Dis. 2008 Jan 1; 46 (1): 20-7.

BackgroundCytomegalovirus (CMV) infection causes morbidity in solid organ transplant (SOT) recipients, either by direct injury or in association with chronic allograft rejection or other opportunistic infections. Ganciclovir is the treatment of choice, but this agent requires intravenous administration, which affects its feasibility for long-term use. Valganciclovir, which has an oral bioavailability of 60%, has proven to be useful for prophylaxis of CMV infection in high-risk SOT recipients and for treating retinitis in persons with acquired immunodeficiency syndrome.ObjectiveTo compare the efficacy of valganciclovir (alone or as sequential therapy after a regimen of intravenous ganciclovir) with intravenous ganciclovir alone for preemptive therapy or treatment of CMV disease (viral syndrome or focal disease) in SOT recipients and to determine the incidence of adverse effects and relapses.MethodsIn this 2-year prospective, comparative cohort study, 376 episodes of preemptive therapy or treatment of CMV disease were recorded among 334 of 3467 SOT recipients included in the Spanish Network for Research on Infection in Transplantation (RESITRA) database. Intravenous ganciclovir was the first-line treatment in 170 episodes; valganciclovir followed by intravenous ganciclovir was administered in 82 episodes, and valganciclovir alone was administered in 112 episodes.ResultsValganciclovir was used as preemptive therapy or treatment for CMV disease in 84 and 28 episodes, respectively. Duration of treatment was longer in valganciclovir recipients than in ganciclovir recipients for both preemptive therapy (21 vs. 15 days; P < .001) or viral syndrome treatment (21 vs. 18 days; P < .01). In the valganciclovir arm, 94 (83.9%) of 112 episodes were treated successfully, with no statistical difference in the success rates versus the ganciclovir arm (85.8%) or ganciclovir-valganciclovir arm (95.1%). Eighteen episodes (16.1%) treated with valganciclovir were considered to have resulted in treatment failure (because of persistent antigenemia in 4 [3.6%], on the basis of clinical decision in 7 [6.2%], and because of recurrent disease in 7 [6.2%]). There were no incidents in which valganciclovir treatment was withdrawn because of toxicity.ConclusionValganciclovir is safe and useful for preemptive therapy and treatment of CMV disease.

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