A PHASE III MULTICENTER STUDY OF VALGANCICLOVIR

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to determine whether valganciclovir is effective in the prevention of late CMV infection. In the current era of effective prophylactic or preemptive ganciclovir therapy, cytomegalovirus infections continue to pose a significant hazard for patients after alloegeneic hematopoietic stem cell transplantation. Ganciclovir has led to a major reduction of CMV disease during the period of highest risk for CMV disease after HSCT. Historically, these cases of "early CMV disease" were defined as those occurring during the first 100 days after transplantation. Ganciclovir effectively prevents CMV disease when given at engraftment or for pp65 antigenemia or detection of CMV DNA by PCR and improves survival in selected high-risk. Late CMV disease occurs primarily between day 100 and day 365 after transplant. Both late CMV infection and disease are independent predictors for mortality after HSCT, even though patients at highest risk for late CMV infection and disease can be identified by day 100. This is because few prophylactic options existed; ganciclovir was only available as intravenous formulation or as a poorly absorbed oral drug. Valganciclovir is an oral prodrug of ganciclovir that is well absorbed, produces an area under the curve (AUC) similar to that of IV ganciclovir and can be given once daily.