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Blood, 1 June 2008, Vol. 111, No. 11, pp. 5403-5410. Prepublished online as a Blood First Edition Paper on February 19, 2008; DOI 10.1182/blood-2007-11-121558. This Article Full Text (PDF) All Versions of this Article: blood-2007-11-121558v1 111/11/5403    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Winston, D. J. Articles by Boeckh, M. Search for Related Content PubMed PubMed Citation Articles by Winston, D. J. Articles by Boeckh, M. Related Collections Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted November 2, 2007 Accepted February 10, 2008 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 F Chemaly, Finn Petersen, Nelson Chao, Jared Klein, Kellie Sprague, Stephen A. Villano, and Michael Boeckh Department of Medicine, University of California, Los Angeles Medical Center, Los Angeles, CA, United States Division of Infectious Diseases and International Medicine, University of Minnesota Medical Center, Minneapolis, MN, United States Division of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, United States Infectious Disease Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United States Division of Oncology, Washington University School of Medicine, St. Louis, MO, United States Department of Oncology, Baylor University Medical Center, Dallas, TX, United States Division of Infectious Disease, Wayne State University & Karmanos Cancer Center, Detroit, MI, United States Department of Infectious Diseases, Infection Control & Emplo, University of Texas M.D. Anderson Cancer Center, Houston, TX, United States Utah Blood and Marrow Transplant Program and the Departments, The University of Utah and the LDS Hospital, Salt Lake City, UT, United States Division of Cell Therapy, Department of Medicine, Duke University Medical Center, Durham, NC, United States Division of Hematology/Oncology, Department of Medicine, Loyola University Medical Center, Maywood, IL, United States Division of Hematology/Oncology, Department of Medicine, Tufts-New England Medical Center, Boston, MA, United States Viropharma Incorporated, Exton, PA, United States Division of Allergy and Infectious Diseases, Fred Hutchinson Cancer Research Center, Seattle, WA, United States * Corresponding author; email: dwinston{at}mednet.ucla.edu. The anti-cytomegalovirus (CMV) activity and safety of oral maribavir in CMV-seropositive allogeneic stem-cell transplant recipients was evaluated in a randomized, double-blind, placebo-controlled, dose-ranging study. After engraftment, 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 following transplantation, the incidence of CMV infection based on CMV pp65 antigenemia was lower in each of the respective maribavir groups (15%, p=0.046; 19%, p=0.116; 15%, p=0.053) compared to placebo (39%). Similarly, the incidence of CMV infection based on plasma CMV DNA was lower in each of the respective maribavir groups (7%, p=0.001; 11%, p=0.007; 19%, p=0.038) compared to placebo (46%). Anti-CMV therapy was also used less often in patients receiving each respective dose of maribavir (15%, p=0.001; 30%, p=0.051; 15%, p=0.002) compared to 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 myelosuppression. This trial is registered at www.ClinicalTrials.gov as #NCT00223925. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: Cytomegalovirus: time for a requiem? Jayesh Mehta Blood 2008 111: 5265-5266. [Full Text] [PDF] This article has been cited by other articles: F.-Z. Wang, D. Roy, E. Gershburg, C. B. Whitehurst, D. P. Dittmer, and J. S. Pagano Maribavir Inhibits Epstein-Barr Virus Transcription in Addition to Viral DNA Replication J. Virol., December 1, 2009; 83(23): 12108 - 12117. [Abstract] [Full Text] [PDF] M. Boeckh and P. Ljungman How we treat cytomegalovirus in hematopoietic cell transplant recipients Blood, June 4, 2009; 113(23): 5711 - 5719. [Abstract] [Full Text] [PDF] T. Allice, A. Busca, F. Locatelli, M. Falda, F. Pittaluga, and V. Ghisetti Valganciclovir as pre-emptive therapy for cytomegalovirus infection post-allogenic stem cell transplantation: implications for the emergence of drug-resistant cytomegalovirus J. Antimicrob. Chemother., March 1, 2009; 63(3): 600 - 608. [Abstract] [Full Text] [PDF] S. Chou Diverse Cytomegalovirus UL27 Mutations Adapt to Loss of Viral UL97 Kinase Activity under Maribavir Antimicrob. Agents Chemother., January 1, 2009; 53(1): 81 - 85. [Abstract] [Full Text] [PDF] J. Trofe, L. Pote, E. Wade, E. Blumberg, and R. D Bloom Maribavir: A Novel Antiviral Agent with Activity Against Cytomegalovirus Ann. Pharmacother., October 1, 2008; 42(10): 1447 - 1457. [Abstract] [Full Text] [PDF]

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