Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study

Drew J. Winston, Jo Anne H. Young, Vinod Pullarkat, Genovefa A. Papanicolaou, Ravi Vij, Estil Vance, George J. Alangaden, Roy R. Chemaly, Finn Petersen, Nelson Chao, Jared Klein, Kellie Sprague, Stephen A. Villano, Michael Boeckh

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Abstract

The anti-cytomegalovirus (CMV) activity and safety of oral maribavir in CMV-seropositive allogeneic stem-cell transplant recipients were evaluated in a randomized, double-blind, placebo-controlled, dose-ranging study. After en-graftment, 111 patients were randomized to receive CMV prophylaxis with maribavir (100 mg twice daily, 400 mg once daily, or 400 mg twice daily) or placebo. Within the first 100 days after transplantation, the incidence of CMV infection based on CMV pp65 antigenemia was lower in each of the respective maribavir groups (15%, P =.046; 19%, P =.116; 15%, P =.053) compared with placebo (39%). Similarly, the incidence of CMV infection based on plasma CMV DNA was lower in each of the respective maribavir groups (7%, P=.001; 11%, P=.007; 19%, P=.038) compared with placebo (46%). Anti-CMV therapy was also used less often in patients receiving each respective dose of maribavir (15%, P=.001; 30%, P=.051; 15%, P =.002) compared with placebo (57%). There were 3 cases of CMV disease in placebo patients but none in the maribavir patients. Adverse events, mostly taste disturbance, nausea, and vomiting, were more frequent with maribavir. Maribavir had no adverse effect on neutrophil or platelet counts. These results show that maribavir can reduce the incidence of CMV infection and, unlike ganciclovir, does not cause myelosup-pression. This trial is registered at www. ClinicalTrials.gov as #NCT00223925.

Original languageEnglish
Pages (from-to)5403-5410
Number of pages8
JournalBlood
Volume111
Issue number11
DOIs
StatePublished - Jun 1 2008

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    Winston, D. J., Young, J. A. H., Pullarkat, V., Papanicolaou, G. A., Vij, R., Vance, E., Alangaden, G. J., Chemaly, R. R., Petersen, F., Chao, N., Klein, J., Sprague, K., Villano, S. A., & Boeckh, M. (2008). Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood, 111(11), 5403-5410. https://doi.org/10.1182/blood-2007-11-121558