Ganciclovir Exposure under a 450 mg Daily Dosage of Valganciclovir for the Prevention of Cytomegalovirus Disease in Kidney Transplant Recipients.
Details
Serval ID
serval:BIB_18DA47E61C5B
Type
Inproceedings: an article in a conference proceedings.
Publication sub-type
Abstract (Abstract): shot summary in a article that contain essentials elements presented during a scientific conference, lecture or from a poster.
Collection
Publications
Institution
Title
Ganciclovir Exposure under a 450 mg Daily Dosage of Valganciclovir for the Prevention of Cytomegalovirus Disease in Kidney Transplant Recipients.
Title of the conference
9th Joint Meeting of the American Society of Transplant Surgeon and of the American Society of Transplantation
Address
Boston, Massachusetts, May 30-June 3, 2009
ISBN
1600-6135
Publication state
Published
Issued date
2009
Peer-reviewed
Oui
Volume
9
Series
American Journal of Transplantation
Pages
249
Language
english
Notes
Publication type : Meeting Abstract
Abstract
Background: It is suggested that a low dose of valganciclovir can be equally
effective than a standard dose for cytomegalovirus (CMV) prophylaxis after kidney
transplantation. The aim of our study was to determine the ganciclovir exposure
observed under a routine daily dosage of 450 mg valganciclovir in kidney transplant
recipients with a wide range of renal function.
Methods: In this prospective study, kidney transplant recipients with a GFR MDRD
above 25 mL/min at risk for CMV (donor or recipient seropositive for CMV) received
a dose of valganciclovir (450 mg daily) prophylaxis for 3 months. Ganciclovir
levels at trough (Ctrough) and at peak (C3h) were measured monthly. Ganciclovir
exposure (AUC0-24) was estimated using Bayesian non-linear mixed-effect modelling
(NONMEM) and compared between 3 groups of patients according to their kidney
function: GFRMDRD 26-39 mL/min (Group 1), GFRMDRD 40-59 mL/min (Group 2)
and GFRMDRD 60-90 mL/min (Group 3). CMV DNAemia was assessed during and
after prophylaxis using PCR.
Results: Thirty-six patients received 450 mg daily of valganciclovir for 3 months.
Median ganciclovir C3h was 3.9 mg/L (range: 1.3-7.1) and Ctrough was 0.4 mg/L (range
0.1-2.7). Median (range) AUC0-24 of ganciclovir was 59.3 mg.h/L (39.0-85.3) in
Group 1 patients, 35.8 mg.h/L (24.9-55.8) in Group 2 patients and 29.6 mg.h/L (22.0-
43.2) in Group 3 patients (p<0.001). Anemia was more common in Group 1 patients
compared to patients on the other groups (p=0.01). No differences in other adverse
events according to ganciclovir exposure were observed. CMV DNAemia was not
detected during prophylaxis. After discontinuing prophylaxis, CMV DNAemia was
seen in 8/34 patients (23.5%) and 4/36 patients (11%) developed CMV disease.
Conclusion: A routine dosage of valganciclovir achieved plasma levels of ganciclovir
in patients with GFR>60 mL/min similar to those previously reported using oral
ganciclovir. A daily dose of 450 mg valganciclovir appears to be acceptable for
CMV prophylaxis in most kidney transplant recipients.
effective than a standard dose for cytomegalovirus (CMV) prophylaxis after kidney
transplantation. The aim of our study was to determine the ganciclovir exposure
observed under a routine daily dosage of 450 mg valganciclovir in kidney transplant
recipients with a wide range of renal function.
Methods: In this prospective study, kidney transplant recipients with a GFR MDRD
above 25 mL/min at risk for CMV (donor or recipient seropositive for CMV) received
a dose of valganciclovir (450 mg daily) prophylaxis for 3 months. Ganciclovir
levels at trough (Ctrough) and at peak (C3h) were measured monthly. Ganciclovir
exposure (AUC0-24) was estimated using Bayesian non-linear mixed-effect modelling
(NONMEM) and compared between 3 groups of patients according to their kidney
function: GFRMDRD 26-39 mL/min (Group 1), GFRMDRD 40-59 mL/min (Group 2)
and GFRMDRD 60-90 mL/min (Group 3). CMV DNAemia was assessed during and
after prophylaxis using PCR.
Results: Thirty-six patients received 450 mg daily of valganciclovir for 3 months.
Median ganciclovir C3h was 3.9 mg/L (range: 1.3-7.1) and Ctrough was 0.4 mg/L (range
0.1-2.7). Median (range) AUC0-24 of ganciclovir was 59.3 mg.h/L (39.0-85.3) in
Group 1 patients, 35.8 mg.h/L (24.9-55.8) in Group 2 patients and 29.6 mg.h/L (22.0-
43.2) in Group 3 patients (p<0.001). Anemia was more common in Group 1 patients
compared to patients on the other groups (p=0.01). No differences in other adverse
events according to ganciclovir exposure were observed. CMV DNAemia was not
detected during prophylaxis. After discontinuing prophylaxis, CMV DNAemia was
seen in 8/34 patients (23.5%) and 4/36 patients (11%) developed CMV disease.
Conclusion: A routine dosage of valganciclovir achieved plasma levels of ganciclovir
in patients with GFR>60 mL/min similar to those previously reported using oral
ganciclovir. A daily dose of 450 mg valganciclovir appears to be acceptable for
CMV prophylaxis in most kidney transplant recipients.
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27/07/2010 16:34
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