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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 (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 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. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted September 21, 2005 Accepted November 23, 2005 Oral valganciclovir leads to higher exposure to ganciclovir than intravenous ganciclovir in patients following allogeneic stem cell transplantation Hermann Einsele*, Pierre Reusser, Martin Bornhauser, Peter Kalhs, Gerhard Ehninger, Holger Hebart, Yves Chalandon, Nicolaus Kroger, Bernd Hertenstein, and Frank Rohde Department of Internal Medicine II, University of Wurzburg, Wurzburg, Germany; Department of Internal Medicine II, Division of Hematology, Oncology, Immunology and Rheumatology, University of Tubingen, Tubingen, Germany Division of Hematology,, University of Basel, University Hospital Basel and Hospital of Jura, Department of Internal Medicine, Porrentruy, Switzerland Department of Internal Medicine I, Division of Hematology and Oncology, University of Dresden, Dresden, Germany Department of Internal Medicine I, Bone Marrow Transplantation Unit, Medical University of Vienna, Vienna, Austria Department of Internal Medicine II, Division of Hematology, Oncology, Immunology and Rheumatology, University of Tubingen, Tubingen, Germany Department of Internal Medicine, Division of Hematology, University of Geneva, Geneva, Switzerland Bone Marrow Transplantation Center, University of Hamburg, Eppendorf University Hospital, Hamburg, Germany Department of Internal Medicine, Division of Hematology and Oncology, Hannover Medical School, Hannover, Germany Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany * Corresponding author; email: einsele_h{at}klinik.uni-wuerzburg.de. 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 to IV-GCV (AUC0-12 53.8 +/-17.97 µg/ml*h, mean +/- SD, vs. 39.5 +/-13.91, P=0.0002, ratio of V-GCV/IV-GCV was 1.4 (90% CI, 1.2 - 1.5)). This was also true in patients with I-GVHD Grade I-II (AUC0-12: 52.9 +/-21.75 vs. 33.1 +/-12.97 µg/ml*h, P=0.0182, 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 Grade 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 Grade I-II. Due to higher exposure after V-GCV compared to 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: A. Caldes, H. Colom, Y. Armendariz, M. J. Garrido, I. F. Troconiz, S. Gil-Vernet, N. Lloberas, L. Pou, C. Peraire, and J. M. Grinyo Population Pharmacokinetics of Ganciclovir after Intravenous Ganciclovir and Oral Valganciclovir Administration in Solid Organ Transplant Patients Infected with Cytomegalovirus Antimicrob. Agents Chemother., November 1, 2009; 53(11): 4816 - 4824. [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] 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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