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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.
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TRANSPLANTATION
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. Winston1,
Jo-Anne H. Young2,
Vinod Pullarkat3,
Genovefa A. Papanicolaou4,
Ravi Vij5,
Estil Vance6,
George J. Alangaden7,
Roy F. Chemaly8,
Finn Petersen9,
Nelson Chao10,
Jared Klein11,
Kellie Sprague12,
Stephen A. Villano13, and
Michael Boeckh14
1 University of California, Los Angeles Medical Center;
2 University of Minnesota Medical Center, Minneapolis;
3 City of Hope National Medical Center, Duarte, CA;
4 Memorial Sloan-Kettering Cancer Center, New York, NY;
5 Washington University School of Medicine, St Louis, MO;
6 Baylor University Medical Center, Dallas, TX;
7 Wayne State University & Karmanos Cancer Center, Detroit, MI;
8 University of Texas M. D. Anderson Cancer Center, Houston;
9 University of Utah and the LDS Hospital, Salt Lake City;
10 Duke University Medical Center, Durham, NC;
11 Loyola University Medical Center, Maywood, IL;
12 Tufts-New England Medical Center, Boston, MA;
13 ViroPharma, Exton, PA; and
14 Fred Hutchinson Cancer Research Center, Seattle, WA
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 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 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 myelosuppression. This trial is registered at www.ClinicalTrials.gov as #NCT00223925
[ClinicalTrials.gov]
.

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