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Blood, 1 April 2006, Vol. 107, No. 7, pp. 3002-3008. Prepublished online as a Blood First Edition Paper on December 13, 2005; DOI 10.1182/blood-2005-09-3786. This Article Full Text Full Text (PDF) All Versions of this Article: 2005-09-3786v1 107/7/3002    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map 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 Einsele, H. Articles by Rohde, F. Search for Related Content PubMed PubMed Citation Articles by Einsele, H. Articles by Rohde, F. Related Collections Transplantation Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  TRANSPLANTATION Oral valganciclovir leads to higher exposure to ganciclovir than intravenous ganciclovir in patients following allogeneic stem cell transplantation Hermann Einsele, Pierre Reusser, Martin Bornhäuser, Peter Kalhs, Gerhard Ehninger, Holger Hebart, Yves Chalandon, Nicolaus Kröger, Bernd Hertenstein, Frank Rohde, for the EBMT Working Group on Infectious Disease From the University of Würzburg, Department of Internal Medicine II, Würzburg, Germany; University of Tübingen, Department of Internal Medicine II, Division of Hematology, Oncology, Immunology and Rheumatology, Tübingen, Germany; University of Basel, Division of Hematology, University Hospital Basel and Hospital of Jura, Department of Internal Medicine, Porrentruy, Switzerland; University of Dresden, Department of Internal Medicine I, Division of Hematology and Oncology, Dresden, Germany; Medical University of Vienna, Department of Internal Medicine I, Bone Marrow Transplantation Unit, Vienna, Austria; University of Geneva, Department of Internal Medicine, Division of Hematology, Geneva, Switzerland; University of Hamburg, Eppendorf University Hospital, Bone Marrow Transplantation Center, Hamburg, Germany; Hannover Medical School, Department of Internal Medicine, Division of Hematology and Oncology, Hannover, Germany; and Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany. Cytomegalovirus (CMV) infection is a major complication after allogeneic stem cell transplantation (SCT). Valganciclovir (V-GCV) is an oral prodrug hydrolyzed to the anti-CMV drug ganciclovir (GCV). A randomized, multicenter, crossover, open-label clinical trial compared exposure to GCV after V-GCV and intravenous GCV (IV-GCV) as preemptive therapy for CMV disease in SCT. The primary objective was to compare exposure to GCV in patients with CMV infection stratified for intestinal graft-versus-host disease (I-GVHD). Secondary objectives were the assessment of safety and efficacy. Patients without I-GVHD had a higher exposure to GCV after V-GCV when compared with IV-GCV (area under the concentration-time curve from drug administration to last observed concentration after 12 hours [AUC0-12] 53.8 ± 17.97 µg/mL · h [mean ± SD] vs 39.5 ± 13.91; P < .001; ratio of V-GCV/IV-GCV was 1.4; 90% confidence interval [CI], 1.2-1.5). This was also true in patients with I-GVHD grades I-II (AUC0-12 52.9 ± 21.75 vs 33.1 ± 12.97 µg/mL · h; P = .018; ratio 1.6; 90% CI, 1.3-2.0). Absolute bioavailability of GCV after V-GCV was approximately 75% in individuals with or without I-GVHD grades I-II. No severe GCV-related toxicity was observed and efficacy and safety was comparable (84-day follow-up). This supports the use of V-GCV in SCT, even in patients with I-GVHD grades I-II. Due to higher exposure after V-GCV compared with IV-GCV, patients should be monitored carefully for safety reasons. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: D. J. Winston, J.-A. H. Young, V. Pullarkat, G. A. Papanicolaou, R. Vij, E. Vance, G. J. Alangaden, R. F. Chemaly, F. Petersen, N. Chao, et al. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study Blood, June 1, 2008; 111(11): 5403 - 5410. [Abstract] [Full Text] [PDF] C. Bressollette-Bodin, A. Claver, D. Boutolleau, P. Chevallier, T. Guillaume, T. Gastinne, P. Moreau, J-L. Harousseau, B.M. Imbert-Marcille, and S. Le Gouill Surgical treatment of a foscavir-resistant atypical Cytomegalovirus pneumonia in an allogeneic stem cell transplant recipient Haematologica, May 1, 2008; 93(5): e39 - e41. [Full Text] [PDF] F. M. Marty, J. Bryar, S. K. Browne, T. Schwarzberg, V. T. Ho, I. V. Bassett, J. Koreth, E. P. Alyea, R. J. Soiffer, C. S. Cutler, et al. Sirolimus-based graft-versus-host disease prophylaxis protects against cytomegalovirus reactivation after allogeneic hematopoietic stem cell transplantation: a cohort analysis Blood, July 15, 2007; 110(2): 490 - 500. [Abstract] [Full Text] [PDF]

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