Tomas Reischig1, Martin Kacer2, Pavel Jindra3, Ondrej Hes4, Daniel Lysak3, Mirko Bouda2. 1. Departments of Internal Medicine I, Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic reischig@fnplzen.cz. 2. Departments of Internal Medicine I, Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic. 3. Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic Hemato-oncology, and. 4. Biomedical Centre, Faculty of Medicine in Pilsen, Charles University in Prague, Pilsen, Czech Republic Pathology, Charles University Medical School and Teaching Hospital, Pilsen, Czech Republic; and.
Abstract
BACKGROUND AND OBJECTIVES: Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus prophylaxis after renal transplantation. A head-to-head comparison of both regimens is lacking. The objective of the study was to compare valacyclovir prophylaxis with valganciclovir, which constituted the control group. DESIGN, SETTINGS, PARTICIPANTS, & MEASUREMENTS: In a randomized, open-label, single-center trial, recipients of renal transplants (recipient or donor cytomegalovirus-seropositive) were randomly allocated (1:1) to 3-month prophylaxis with valacyclovir (2 g four times daily) or valganciclovir (900 mg daily). Enrollment occurred from November of 2007 to April of 2012. The primary end points were cytomegalovirus DNAemia and biopsy-proven acute rejection at 12 months. Analysis was by intention to treat. RESULTS: In total, 119 patients were assigned tovalacyclovir (n=59) or valganciclovir prophylaxis (n=60). Cytomegalovirus DNAemia developed in 24 (43%) of 59 patients in the valacyclovir group and 18 (31%) of 60 patients in the valganciclovir group (adjusted hazard ratio, 1.35; 95% confidence interval, 0.71 to 2.54; P=0.36). The incidence of cytomegalovirus disease was 2% with valacyclovir and 5% with valganciclovir prophylaxis (adjusted hazard ratio, 0.21; 95% confidence interval, 0.01 to 5.90; P=0.36). Significantly more patients with valacyclovir prophylaxis developed biopsy-proven acute rejection (18 of 59 [31%] versus 10 of 60 [17%]; adjusted hazard ratio, 2.49; 95% confidence interval, 1.09 to 5.65; P=0.03). The incidence of polyomavirus viremia was higher in the valganciclovir group (18% versus 36%; adjusted hazard ratio, 0.43; 95% confidence interval, 0.19 to 0.96; P=0.04). CONCLUSIONS:Valganciclovir shows no superior efficacy in cytomegalovirus DNAemia prevention compared with valacyclovir prophylaxis. However, the risk of biopsy-proven acute rejection is higher with valacyclovir.
RCT Entities:
BACKGROUND AND OBJECTIVES: Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus prophylaxis after renal transplantation. A head-to-head comparison of both regimens is lacking. The objective of the study was to compare valacyclovir prophylaxis with valganciclovir, which constituted the control group. DESIGN, SETTINGS, PARTICIPANTS, & MEASUREMENTS: In a randomized, open-label, single-center trial, recipients of renal transplants (recipient or donor cytomegalovirus-seropositive) were randomly allocated (1:1) to 3-month prophylaxis with valacyclovir (2 g four times daily) or valganciclovir (900 mg daily). Enrollment occurred from November of 2007 to April of 2012. The primary end points were cytomegalovirus DNAemia and biopsy-proven acute rejection at 12 months. Analysis was by intention to treat. RESULTS: In total, 119 patients were assigned to valacyclovir (n=59) or valganciclovir prophylaxis (n=60). Cytomegalovirus DNAemia developed in 24 (43%) of 59 patients in the valacyclovir group and 18 (31%) of 60 patients in the valganciclovir group (adjusted hazard ratio, 1.35; 95% confidence interval, 0.71 to 2.54; P=0.36). The incidence of cytomegalovirus disease was 2% with valacyclovir and 5% with valganciclovir prophylaxis (adjusted hazard ratio, 0.21; 95% confidence interval, 0.01 to 5.90; P=0.36). Significantly more patients with valacyclovir prophylaxis developed biopsy-proven acute rejection (18 of 59 [31%] versus 10 of 60 [17%]; adjusted hazard ratio, 2.49; 95% confidence interval, 1.09 to 5.65; P=0.03). The incidence of polyomavirus viremia was higher in the valganciclovir group (18% versus 36%; adjusted hazard ratio, 0.43; 95% confidence interval, 0.19 to 0.96; P=0.04). CONCLUSIONS:Valganciclovir shows no superior efficacy in cytomegalovirus DNAemia prevention compared with valacyclovir prophylaxis. However, the risk of biopsy-proven acute rejection is higher with valacyclovir.
Authors: D Lowance; H H Neumayer; C M Legendre; J P Squifflet; J Kovarik; P J Brennan; D Norman; R Mendez; M R Keating; G L Coggon; A Crisp; I C Lee Journal: N Engl J Med Date: 1999-05-13 Impact factor: 91.245
Authors: I D Pavlopoulou; V Ph Syriopoulou; H Chelioti; G L Daikos; D Stamatiades; A Kostakis; J N Boletis Journal: Clin Microbiol Infect Date: 2005-09 Impact factor: 8.067
Authors: J Hjelmesaeth; S Sagedal; A Hartmann; H Rollag; T Egeland; M Hagen; K P Nordal; T Jenssen Journal: Diabetologia Date: 2004-08-27 Impact factor: 10.122
Authors: Anne-Grete Märtson; Martijn Bakker; Hans Blokzijl; Erik A M Verschuuren; Stefan P Berger; Lambert F R Span; Tjip S van der Werf; Jan-Willem C Alffenaar Journal: BMJ Open Date: 2020-01-07 Impact factor: 2.692
Authors: Margaret R Jorgenson; Jillian L Descourouez; Cynthia Wong; Jill R Strayer; Sandesh Parajuli; John P Rice; Robert R Redfield; Jeannina A Smith; Didier A Mandelbrot; Christopher M Saddler Journal: Transpl Infect Dis Date: 2021-03-15
Authors: Tomas Reischig; Martin Kacer; Petra Hruba; Hana Hermanova; Ondrej Hes; Daniel Lysak; Stanislav Kormunda; Mirko Bouda Journal: BMC Infect Dis Date: 2018-11-15 Impact factor: 3.090