Valganciclovir for the prophylaxis of cytomegalovirus infection early after allogenic stem cell transplantation

Despite improvements in methods for the early diagnosis of Cytomegalovirus (CMV) infection, 5% of allogeneic stem cell transplant patients receiving preemptive therapy develop CMV disease. In addition, the use of highly immunosuppressive and the use of mismatched donors have increased the incidence of CMV infection and disease. Thirty CMV seropositive patients participated in a prospective trial evaluating the safety and efficacy of oral valganciclovir administered at 900 mg daily 5 days a week starting 21 to 35 days after transplant and continuing through Day 100 post transplant. Twenty-four of 30 (80%) patients had other risk factors for the development of CMV infection including: use of alemtuzumab (n=9), corticosteroid therapy for treatment of graft versus host disease (n=12), or unrelated donor transplant (n=12). Patients were monitored with weekly quantitative CMV PCR analysis at a central lab. Five patients developed myeloid toxicity related to valganciclovir (absolute neutrophil count < 1,000/µL = 1, platelets < 50,000/µL = 4). CMV infection occurred in 4 patients with no CMV disease in any of the patients. We conclude that valganciclovir at the dose used in this study is well tolerated with minimal, reversible myelosuppression. The incidence of CMV infection with valganciclovir prophylaxis was low in this high-risk group.