13 results on '"Jindra, Pavel"'
Search Results
2. Cytomegalovirus prevention strategies and the risk of BK polyomavirus viremia and nephropathy.
- Author
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Reischig T, Kacer M, Hes O, Machova J, Nemcova J, Lysak D, Jindra P, Pivovarcikova K, Kormunda S, and Bouda M
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- Adult, BK Virus, Cytomegalovirus, Female, Graft Survival, Humans, Kidney Failure, Chronic complications, Male, Middle Aged, Multivariate Analysis, Premedication, Proportional Hazards Models, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors, Treatment Outcome, Valacyclovir therapeutic use, Valganciclovir therapeutic use, Cytomegalovirus Infections prevention & control, Kidney Failure, Chronic surgery, Kidney Transplantation adverse effects, Polyomavirus Infections virology, Tumor Virus Infections prevention & control, Viremia etiology
- Abstract
Polyomavirus BK (BKV) is the cause of polyomavirus-associated nephropathy resulting in premature graft loss. There are limited data regarding the role of cytomegalovirus (CMV) infection and its prevention in developing BKV viremia and PVAN. In a prospective study, we analyzed 207 consecutive renal transplant recipients previously enrolled in 2 randomized trials evaluating different CMV prevention regimens with routine screening for BKV and CMV. Of these, 59 received valganciclovir and 100 valacyclovir prophylaxis; 48 patients were managed by preemptive therapy. At 3 years, the incidence of BKV viremia and PVAN was 28% and 5%, respectively. CMV DNAemia developed in 55% and CMV disease in 6%. Both BKV viremia (42% vs 23% vs 21%, P = .006) and PVAN (12% vs 2% vs 2%, P = .011) were increased in patients treated with valganciclovir prophylaxis compared to valacyclovir and preemptive therapy. Using multivariate Cox proportional hazard regression, valganciclovir prophylaxis was independent predictor of BKV viremia (hazard ratio [HR] = 2.38, P = .002) and PVAN (HR = 4.73, P = .026). In contrast, the risk of subsequent BKV viremia was lower in patients with antecedent CMV DNAemia (HR = 0.50, P = .018). These data suggest valganciclovir prophylaxis may be associated with increased risk of BKV viremia and PVAN. CMV DNAemia did not represent a risk for BKV., (© 2019 The American Society of Transplantation and the American Society of Transplant Surgeons.)
- Published
- 2019
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3. The impact of viral load and time to onset of cytomegalovirus replication on long-term graft survival after kidney transplantation.
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Reischig T, Kacer M, Hruba P, Jindra P, Hes O, Lysak D, Bouda M, and Viklicky O
- Subjects
- Biopsy, Cytomegalovirus Infections prevention & control, DNA, Viral, Female, Follow-Up Studies, Graft Rejection immunology, Humans, Kidney Function Tests, Male, Prospective Studies, Risk, Time Factors, Viremia, Cytomegalovirus physiology, Cytomegalovirus Infections diagnosis, Cytomegalovirus Infections etiology, Graft Survival, Kidney Transplantation adverse effects, Viral Load, Virus Replication
- Abstract
Background: Asymptomatic cytomegalovirus (CMV) infection is associated with graft dysfunction and failure. However, no study assessed CMV viral load in terms of the risk for graft failure., Methods: In a prospective cohort of kidney transplant recipients, we assessed the impact of CMV DNAemia on the overall graft survival and the incidence of moderate-to-severe interstitial fibrosis and tubular atrophy (IF/TA) in protocol biopsy at 36 months. CMV DNAemia was stratified by viral load in whole blood., Results: A total of 180 patients transplanted from October 2003 through January 2011 were included and followed for 4 years; 87 (48%) patients received 3-month prophylaxis with valacyclovir and 45 (25%) with valganciclovir; 48 (27%) were managed by pre-emptive therapy. Within 12 months of transplantation, CMV DNAemia developed in 102 (57%) patients with 36 (20%) having a viral load of ≥2,000 copies/ml. Multivariate Cox analysis identified CMV DNAemia as an independent risk factor for graft loss (hazard ratio 3.42; P=0.020); however, after stratification by viral load, only CMV DNAemia ≥2,000 copies/ml (hazard ratio 7.62; P<0.001) remained significant. Both early-onset (<3 months; P=0.048) and late-onset (>3 months; P<0.001) CMV DNAemia ≥2,000 copies/ml were risk factors for graft loss. The incidence of moderate-to-severe IF/TA was not significantly influenced by CMV DNAemia., Conclusions: Kidney transplant recipients having CMV DNAemia with a higher viral load irrespective of the time to onset are at increased risk for graft loss.
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- 2017
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4. Randomized trial of valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation.
- Author
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Reischig T, Kacer M, Jindra P, Hes O, Lysak D, and Bouda M
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- Acute Disease, Acyclovir administration & dosage, Acyclovir adverse effects, Adult, Antiviral Agents adverse effects, Biomarkers blood, Biopsy, Cytomegalovirus drug effects, Cytomegalovirus genetics, Cytomegalovirus Infections diagnosis, Cytomegalovirus Infections immunology, Cytomegalovirus Infections virology, Czech Republic, DNA, Viral blood, Drug Administration Schedule, Female, Ganciclovir administration & dosage, Ganciclovir adverse effects, Graft Rejection diagnosis, Graft Rejection immunology, Graft Rejection prevention & control, Graft Survival drug effects, Humans, Immunosuppressive Agents therapeutic use, Intention to Treat Analysis, Male, Middle Aged, Time Factors, Treatment Outcome, Valacyclovir, Valganciclovir, Valine administration & dosage, Valine adverse effects, Viral Load, Acyclovir analogs & derivatives, Antiviral Agents administration & dosage, Cytomegalovirus Infections prevention & control, Ganciclovir analogs & derivatives, Kidney Transplantation adverse effects, Valine analogs & derivatives
- 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 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., (Copyright © 2015 by the American Society of Nephrology.)
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- 2015
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5. Long-term outcomes of pre-emptive valganciclovir compared with valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation.
- Author
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Reischig T, Hribova P, Jindra P, Hes O, Bouda M, Treska V, and Viklicky O
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- Acyclovir therapeutic use, Adult, Atrophy, Biopsy, Cytomegalovirus Infections mortality, Female, Fibrosis, Follow-Up Studies, Ganciclovir therapeutic use, Graft Survival, Humans, Kaplan-Meier Estimate, Kidney pathology, Kidney virology, Longitudinal Studies, Male, Middle Aged, Treatment Outcome, Valacyclovir, Valganciclovir, Valine therapeutic use, Acyclovir analogs & derivatives, Antiviral Agents therapeutic use, Cytomegalovirus isolation & purification, Cytomegalovirus Infections prevention & control, Ganciclovir analogs & derivatives, Kidney Transplantation mortality, Valine analogs & derivatives
- Abstract
Prevention of cytomegalovirus (CMV) is essential in organ transplantation. The two main strategies are pre-emptive therapy, in which one screens for and treats asymptomatic CMV viremia, and universal antiviral prophylaxis. We compared these strategies and examined long-term outcomes in a randomized, open-label, single-center trial. We randomly assigned 70 renal transplant recipients (CMV-seropositive recipient or donor) to 3-month prophylaxis with valacyclovir (n=34) or pre-emptive valganciclovir for significant CMV viremia detected at predefined assessments through month 12 (n=36). Among the 55 patients who had a protocol biopsy specimen available at 3 years to allow assessment of the primary outcome, 9 (38%) of 24 patients in the prophylaxis group and 6 (19%) of 31 patients in the pre-emptive therapy group had moderate to severe interstitial fibrosis and tubular atrophy (odds ratio, 2.50; 95% confidence interval, 0.74-8.43; P=0.22). The prophylaxis group had significantly higher intrarenal mRNA expression of genes involved in fibrogenesis. The occurrence of CMV disease was similar in both groups, but pre-emptive therapy improved 4-year graft survival (92% versus 74%; P=0.049) as a result of worse outcomes in patients with late-onset CMV viremia. In conclusion, compared with valacyclovir prophylaxis, pre-emptive valganciclovir therapy may lead to less severe interstitial fibrosis and tubular atrophy and to significantly better graft survival.
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- 2012
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6. Pharmacoeconomic impact of different regimens to prevent cytomegalovirus infection in renal transplant recipients.
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Kielberger L, Bouda M, Jindra P, and Reischig T
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- Acyclovir administration & dosage, Acyclovir analogs & derivatives, Acyclovir economics, Adult, Antiviral Agents administration & dosage, Economics, Pharmaceutical, Female, Ganciclovir administration & dosage, Ganciclovir economics, Graft Survival drug effects, Humans, Kidney Transplantation adverse effects, Male, Middle Aged, Prospective Studies, Valacyclovir, Valine administration & dosage, Valine analogs & derivatives, Valine economics, Antiviral Agents economics, Cytomegalovirus Infections economics, Cytomegalovirus Infections prevention & control, Kidney Transplantation economics, Postoperative Complications economics, Postoperative Complications prevention & control
- Abstract
Background: The aim of this study was to determine the cost impact of four different strategies for prevention of cytomegalovirus (CMV) disease after renal transplantation., Methods: Hospitalization data and medical resource utilization data were prospectively collected alongside two randomized trials. In the first trial, the patients were randomized to 3-month prophylaxis with either oral ganciclovir (1 g t.i.d., n = 36) or valacyclovir (2 g q.i.d., n = 35), and to the control group (n = 12) managed by deferred therapy. In the second trial, the patients were randomly assigned to 3-month valacyclovir prophylaxis (n = 34) or preemptive therapy with valganciclovir (900 mg b.i.d. for a minimum of 14 days, n = 36) for significant CMV DNAemia. The cost analysis involved all real costs directly related to CMV during the first year after renal transplantation., Results: The mean CMV-associated costs per patient were EUR 4,581, 2,577, 4,968, and 8,050 in patients in the ganciclovir, valacyclovir, preemptive, and deferred therapy groups, respectively (p < 0.001). Valacyclovir prophylaxis was significantly less expensive than any other regimen. The cost of one episode of CMV disease was EUR 7,510 per patient. Due to excessive incidence of CMV disease, deferred therapy was the most expensive strategy (p < 0.001)., Conclusions: Valacyclovir prophylaxis is less expensive strategy compared with any other regimen., (Copyright © 2012 S. Karger AG, Basel.)
- Published
- 2012
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7. Valganciclovir prophylaxis against cytomegalovirus impairs lymphocyte proliferation and activation in renal transplant recipients.
- Author
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Reischig T, Prucha M, Sedlackova L, Lysak D, Jindra P, Bouda M, and Matejovic M
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- Acyclovir administration & dosage, Acyclovir analogs & derivatives, Acyclovir therapeutic use, Adult, Antiviral Agents therapeutic use, Cells, Cultured, Concanavalin A pharmacology, Cytomegalovirus immunology, Cytomegalovirus Infections drug therapy, Cytomegalovirus Infections etiology, Cytomegalovirus Infections virology, Female, Ganciclovir administration & dosage, Ganciclovir therapeutic use, Humans, Immunosuppression Therapy adverse effects, Immunosuppressive Agents administration & dosage, Immunosuppressive Agents adverse effects, Lymphocyte Activation drug effects, Lymphocyte Count, Male, Middle Aged, Phytohemagglutinins pharmacology, T-Lymphocyte Subsets cytology, T-Lymphocyte Subsets drug effects, T-Lymphocyte Subsets immunology, Valacyclovir, Valganciclovir, Valine administration & dosage, Valine analogs & derivatives, Valine therapeutic use, Antiviral Agents administration & dosage, Cell Proliferation drug effects, Cytomegalovirus drug effects, Cytomegalovirus Infections prevention & control, Ganciclovir analogs & derivatives, Graft Rejection prevention & control, Graft Survival drug effects, Kidney Transplantation immunology
- Abstract
Background: Antiviral prophylaxis against cytomegalovirus has been associated with reduced risk of allograft rejection and improved allograft survival after renal transplantation. This phenomenon might not be fully explained by preventing the indirect effects of cytomegalovirus. The effect of antiviral agents on lymphocyte function in patients treated with modern immunosuppression has not been studied to date., Methods: Adult renal transplant recipients were assigned to 3-month prophylaxis with either valganciclovir (900 mg once daily; n=19) or valacyclovir (2 g four times daily; n=17) as part of an ongoing randomized trial. Subsets of lymphocytes, lymphocyte proliferation and/or cytokine production after in vitro mitogen stimulation were evaluated at the end of prophylaxis and 1 month after withdrawal of antiviral drugs., Results: Lymphocyte proliferation was significantly decreased both after phytohemagglutinine (25% ±15% versus 32% ±18%; P=0.025) and concanavalin A stimulation (17% ±9% versus 25% ±16%; P=0.011) during valganciclovir, but not valacyclovir therapy. Moreover, a lower activated T-cell count (CD3(+)HLA-DR(+) cells) was noted in valganciclovir-treated patients (13% ±10% versus 17% ±12% of total CD3(+) T-cells; P=0.005)., Conclusions: Valganciclovir suppresses lymphocyte proliferation and activation in patients after renal transplantation.
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- 2011
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8. Intragraft cytomegalovirus infection: a randomized trial of valacyclovir prophylaxis versus pre-emptive therapy in renal transplant recipients.
- Author
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Reischig T, Nemcová J, Vanecek T, Jindra P, Hes O, Bouda M, and Treska V
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- Acyclovir administration & dosage, Cytomegalovirus drug effects, Cytomegalovirus Infections etiology, Double-Blind Method, Ganciclovir administration & dosage, Graft Rejection, Humans, Risk Factors, Transplantation, Homologous, Treatment Outcome, Valacyclovir, Valganciclovir, Valine administration & dosage, Viremia drug therapy, Viremia etiology, Viremia prevention & control, Acyclovir analogs & derivatives, Antiviral Agents administration & dosage, Cytomegalovirus Infections drug therapy, Cytomegalovirus Infections prevention & control, Ganciclovir analogs & derivatives, Kidney Transplantation, Postoperative Complications, Premedication, Valine analogs & derivatives
- Abstract
Background: In a randomized study, we observed a higher incidence of biopsy-proven acute rejection with pre-emptive valganciclovir therapy as compared with valacyclovir prophylaxis for prevention of cytomegalovirus (CMV) disease after renal transplantation (RTx). Persistence of the virus within the allograft could stimulate the alloimmune response. The aim of our study was to evaluate intragraft CMV infection in patients randomized to the trial., Methods: RTx recipients at risk of CMV were randomized to pre-emptive therapy with valganciclovir (n=36) for significant CMV viraemia (> or =2,000 copies/ml by quantitative PCR in whole blood samples) or 3-month prophylaxis with valacyclovir (n=34). Renal biopsies performed during 12 months post-RTx were analysed for the presence of CMV by real-time PCR and immunohistochemical staining., Results: A total of 35 patients (59 biopsies) in the pre-emptive group and 31 patients (57 biopsies) with valacyclovir prophylaxis had > or =1 biopsy specimen with sufficient material for intragraft CMV determination. Cumulative incidence of intragraft CMV infection was 14% and 7% (P=0.315) with pre-emptive therapy and prophylaxis, respectively. Patients at risk for primary CMV infection (CMV serological donor-positive and recipient-negative) were at higher risk for intragraft CMV infection (40% versus 5%; P=0.008). CMV viraemia at the time of biopsy was associated with the presence of CMV within the allograft (P<0.001)., Conclusions: During the first year after RTx, the incidence of intragraft CMV infection was relatively low with comparable rates in patients managed by pre-emptive valganciclovir therapy and valacyclovir prophylaxis.
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- 2010
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9. Effect of cytomegalovirus viremia on subclinical rejection or interstitial fibrosis and tubular atrophy in protocol biopsy at 3 months in renal allograft recipients managed by preemptive therapy or antiviral prophylaxis.
- Author
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Reischig T, Jindra P, Hes O, Bouda M, Kormunda S, and Treska V
- Subjects
- Adult, Atrophy, Biopsy, Cyclosporine therapeutic use, Cytomegalovirus Infections drug therapy, Cytomegalovirus Infections prevention & control, Female, Fibrosis, Follow-Up Studies, Humans, Immunosuppressive Agents therapeutic use, Kidney Transplantation immunology, Kidney Transplantation mortality, Kidney Transplantation pathology, Male, Middle Aged, Patient Selection, Retrospective Studies, Risk Factors, Survival Analysis, Survivors, Time Factors, Viral Load, Viremia drug therapy, Viremia prevention & control, Antiviral Agents therapeutic use, Cytomegalovirus Infections epidemiology, Kidney Transplantation adverse effects, Kidney Tubules pathology, Viremia epidemiology
- Abstract
Background: Cytomegalovirus (CMV) is a risk factor for acute renal allograft rejection. The aim of this study was to determine the impact of CMV viremia on subclinical rejection (SCR) and interstitial fibrosis and tubular atrophy (IF/TA) in protocol biopsy at 3 months after transplantation., Methods: A total of 118 consecutive renal transplant recipients at risk for CMV (donor and recipient CMV seropositive) were included and followed up prospectively. Protocol biopsies with sufficient tissue were obtained in 102 patients. CMV activity was monitored using real-time polymerase chain reaction in whole blood. Three-month prophylaxis with valacyclovir or ganciclovir was given in 60 patients, whereas the remaining 42 patients were managed by preemptive therapy. Multivariate logistic stepwise regression analysis was used to estimate the effect of CMV viremia and other covariates on SCR and IF/TA., Results: CMV viremia occurred in 41% of the patients with a median peak viral load of 1300 copies/mL. The incidence of SCR and IF/TA was 29% and 28%, respectively. CMV viremia was not a risk factor for SCR (OR=0.77, P=0.551); however, viremia of more than or equal to 2000 copies/mL increased the risk of IF/TA (OR=3.83, P=0.023). Biopsy-proven acute rejection (OR=3.34, P=0.009) and sirolimus-based immunosuppression (OR=6.13, P=0.008) were independent predictors of SCR. Delayed-graft function (OR=6.02, P=0.001) and donor age (OR=1.53 per 10-year increase, P=0.009) were associated with IF/TA., Conclusions: CMV viremia is not an independent risk factor for SCR. CMV viremia with viral load of more than or equal to 2000 copies/mL is associated with increased risk of IF/TA in protocol biopsy at 3 months after transplantation.
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- 2009
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10. The impact of cytomegalovirus disease and asymptomatic infection on acute renal allograft rejection.
- Author
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Reischig T, Jindra P, Svecová M, Kormunda S, Opatrný K Jr, and Treska V
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- Acute Disease, Acyclovir analogs & derivatives, Acyclovir therapeutic use, Antiviral Agents therapeutic use, Carrier State, Cytomegalovirus genetics, Cytomegalovirus isolation & purification, Cytomegalovirus Infections prevention & control, Cytomegalovirus Infections virology, Female, Ganciclovir therapeutic use, Graft Rejection etiology, Humans, Incidence, Male, Middle Aged, Multivariate Analysis, Prospective Studies, Risk Factors, Treatment Outcome, Valacyclovir, Valine analogs & derivatives, Valine therapeutic use, Cytomegalovirus Infections complications, Graft Rejection epidemiology, Kidney Transplantation adverse effects, Postoperative Complications prevention & control
- Abstract
Background: Cytomegalovirus (CMV) disease is a risk factor for allograft rejection in renal transplant (RTx) recipients. However, the role of asymptomatic CMV infection remains controversial., Objectives: To determine the impact of CMV disease and asymptomatic infection on biopsy-proven acute rejection (BPAR) during 12 months post-RTx., Study Design: A total of 106 consecutive RTx recipients at risk for CMV (donor and/or recipient CMV seropositive) were followed prospectively for 12 months post-RTx. CMV activity was monitored using nested PCR from whole blood. Three-month prophylaxis with valacyclovir or ganciclovir was given to 94 patients. BPAR episodes were classified according to the Banff 97 criteria. Multivariate Cox proportional hazards model was used to estimate the effect of CMV disease, asymptomatic infection, and other covariates on BPAR., Results: Asymptomatic CMV infection occurred in 23% of the patients and 10% developed CMV disease. The incidence of BPAR was 29%. CMV disease was an independent risk factor for BPAR (HR=3.0, P=0.014), while asymptomatic CMV infection was not (P=0.987). In addition to CMV disease, expanded criteria donor and donor age were independent predictors for BPAR. In univariate analysis, valacyclovir (HR=0.26, P=0.008) decreased the risk of BPAR. A similar trend was observed with ganciclovir (HR=0.42, P=0.058). Only valacyclovir remained significant in multivariate analysis (HR=0.18, P=0.044)., Conclusions: CMV disease, but not asymptomatic infection, is an independent risk factor for BPAR during the first 12 months post-RTx.
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- 2006
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11. Valacyclovir for cytomegalovirus prophylaxis reduces the risk of acute renal allograft rejection.
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Reischig T, Jindra P, Mares J, Cechura M, Svecová M, Hes O, Opatrný K Jr, and Treska V
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- Acyclovir adverse effects, Adult, Female, Ganciclovir adverse effects, Graft Rejection epidemiology, Histocompatibility Testing, Humans, Immunosuppressive Agents therapeutic use, Kidney Diseases classification, Kidney Diseases surgery, Kidney Transplantation mortality, Male, Middle Aged, Reoperation, Risk Factors, Survival Analysis, Time Factors, Transplantation, Homologous, Valacyclovir, Valine adverse effects, Acyclovir analogs & derivatives, Acyclovir therapeutic use, Antiviral Agents therapeutic use, Cytomegalovirus Infections prevention & control, Ganciclovir therapeutic use, Graft Rejection prevention & control, Kidney Transplantation physiology, Valine analogs & derivatives, Valine therapeutic use
- Abstract
Background: Both oral ganciclovir and valacyclovir decrease the incidence of cytomegalovirus (CMV) disease after renal transplantation. Moreover, valacyclovir has been shown to reduce the risk of acute rejection. Our study was designed to compare the efficacy and safety of oral ganciclovir and valacyclovir in the prophylaxis of CMV disease after renal transplantation., Methods: A total of 83 patients were prospectively randomized to 3-month treatment with oral ganciclovir (3 g/day, n=36, GAN) or oral valacyclovir (8 g/day, n=35, VAL). A control group (DEF, n=12) was managed by deferred therapy., Results: No differences were found in demography, immunosuppression, or donor/recipient CMV serology. The 12-month incidence of CMV disease was 67% in the DEF group compared with 6% in the GAN group and 3% in the VAL group (P<0.001 GAN or VAL vs. DEF; P=0.575 GAN vs. VAL). The biopsy-confirmed acute rejection rate at 12 months was 12% in the VAL group compared with 34% in the GAN group (P=0.030) and 58% in the DEF group (P<0.001). The difference between the GAN and DEF groups was not significant (P=0.087). The average CMV-associated costs per patient were $3,072, $2,906, and $4,906 in the GAN, VAL, and DEF groups, respectively., Conclusions: Valacyclovir and oral ganciclovir are equally effective in the prevention of CMV disease after renal transplantation. Both regimens are cost-effective. Valacyclovir is associated with a significantly reduced risk of acute rejection compared with both ganciclovir prophylaxis and deferred therapy.
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- 2005
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12. Prospective comparison of valacyclovir and oral ganciclovir for prevention of cytomegalovirus disease in high-risk renal transplant recipients.
- Author
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Reischig T, Opatrný K Jr, Treska V, Mares J, Jindra P, and Svecová M
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- Acyclovir administration & dosage, Acyclovir adverse effects, Administration, Oral, Adult, Antiviral Agents adverse effects, Cytomegalovirus Infections economics, Cytomegalovirus Infections mortality, Female, Ganciclovir adverse effects, Graft Rejection drug therapy, Graft Survival, Health Care Costs, Humans, Immunosuppressive Agents therapeutic use, Male, Middle Aged, Postoperative Complications economics, Postoperative Complications prevention & control, Postoperative Complications virology, Prospective Studies, Risk Factors, Valacyclovir, Valine administration & dosage, Valine adverse effects, Viremia economics, Viremia mortality, Viremia prevention & control, Acyclovir analogs & derivatives, Antiviral Agents administration & dosage, Cytomegalovirus Infections prevention & control, Ganciclovir administration & dosage, Kidney Transplantation mortality, Valine analogs & derivatives
- Abstract
Aims: To compare the efficacy, costs and safety of oral ganciclovir and valacyclovir in the prophylaxis of cytomegalovirus (CMV) disease in renal transplant (RTx) recipients at high risk of CMV disease., Methods: A total of 83 patients were prospectively randomized to 3-month treatment with either oral ganciclovir (3 g/day) or oral valacyclovir (8 g/day). A 3rd group received no prophylaxis. Forty-nine patients were considered to be at high risk of CMV disease due to D+R- serologic status, OKT3/ATG treatment and/or acute rejection within 12 months after RTx. Twenty-three high-risk patients were treated with ganciclovir (GAN group), 17 patients with valacyclovir (VAL group), and 9 patients received no prophylaxis (C group)., Results: No significant differences were found among the groups in their demographic characteristics, immunosuppressive protocols, D/R CMV serology, or CMV risk factors. The 12-month incidence of CMV disease was 89% in the C group compared with 9% in the GAN group and 6% in the VAL group (p < 0.001, GAN or VAL vs. C; p = 0.713, GAN vs. VAL). Treatment failure (death, graft loss, CMV disease or withdrawal from study) occurred in 17, 6, and 89% in the GAN, VAL, and C groups, respectively (p < 0.001, GAN or VAL vs. C; p = 0.285, GAN vs. VAL). The average CMV-associated costs per patient were EUR 3,161, 3,757, and 7,247 in the GAN, VAL, and C groups, respectively (p = 0.027)., Conclusion: Valacyclovir and oral ganciclovir are equally effective in the prophylaxis of CMV disease in high-risk RTx patients. Both regimens are cost-effective and help reduce CMV-associated costs by nearly 50% compared with patients without prophylaxis.
- Published
- 2005
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13. A randomized prospective controlled trial of oral ganciclovir versus oral valacyclovir for prophylaxis of cytomegalovirus disease after renal transplantation.
- Author
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Reischig T, Opatrny K Jr, Bouda M, Treska V, Jindra P, and Svecova M
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- Acyclovir administration & dosage, Administration, Oral, Adult, Antiviral Agents administration & dosage, Antiviral Agents therapeutic use, Cadaver, Dose-Response Relationship, Drug, Female, Ganciclovir administration & dosage, Humans, Kidney Diseases classification, Kidney Diseases surgery, Living Donors, Male, Middle Aged, Postoperative Complications prevention & control, Prospective Studies, Renal Insufficiency etiology, Renal Insufficiency surgery, Tissue Donors, Valacyclovir, Valine administration & dosage, Acyclovir analogs & derivatives, Acyclovir therapeutic use, Cytomegalovirus Infections prevention & control, Ganciclovir therapeutic use, Kidney Transplantation adverse effects, Postoperative Complications virology, Valine analogs & derivatives, Valine therapeutic use
- Abstract
Oral ganciclovir and valacyclovir reduce the incidence of cytomegalovirus (CMV) disease after renal transplantation (RTx). Our study was designed to compare the efficacy, costs, and safety of oral ganciclovir and valacyclovir in the prophylaxis of CMV disease over the first 6 months after RTx. A total of 38 patients was randomized to 3-month treatment with either oral ganciclovir (1 g t.i.d., n=14, GAN group) or oral valacyclovir (2 g q.i.d., n=12, VAL group). A third group (C, n=12) received no prophylaxis. The patients were monitored by CMV-nested PCR in whole blood. No differences were found between the groups in their demographic characteristics, immunosuppressive protocols, or donor and recipient CMV serology. Thirty-six out of 38 (94.7%) recipients were CMV-seropositive. Over the 6-month post-RTx period, there were 13 episodes of CMV disease in eight (66.7%) patients of the C group compared with none in the GAN and VAL groups ( P=0.0005, GAN vs C; P=0.001, VAL vs C). The incidence of CMV viremia was 30.8%, 50.0%, and 91.7% in the GAN, VAL, and C groups, respectively ( P=0.004, GAN vs C; P=0.07, VAL vs C; P=NS, GAN vs VAL). Treatment failure (death, graft loss, CMV disease, or withdrawal from study) occurred in 14.3%, 0% and 66.7% in the GAN, VAL, and C groups, respectively ( P=0.014, GAN vs C; P=0.001, VAL vs C; P=NS, GAN vs VAL). The average CMV-associated costs per patient (in 2001 euros) were 2,449+/-1,178, 2,485+/-581, and 4,259+/-4,616 in the GAN, VAL, and C groups, respectively. Ganciclovir and valacyclovir were well tolerated, with ganciclovir having had to be withdrawn shortly in one patient only because of thrombocytopenia. In conclusion, oral ganciclovir and valacyclovir are equally safe and effective in the prophylaxis of CMV disease after RTx. Both are cost-effective and help reduce CMV-associated costs by some 40% compared with patients without prophylaxis.
- Published
- 2002
- Full Text
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