BACKGROUND: Cytomegalovirus (CMV) prophylaxis may prevent CMV indirect effects in renal transplant recipients. This study aimed to compare the efficacy of valganciclovir and valacyclovir prophylaxis for CMV after renal transplantation with the focus on chronic histologic damage within the graft. METHODS: From November 2007 through April 2012, adult renal transplant recipients were randomized, in an open-label, single-center study, at a 1:1 ratio to 3-month prophylaxis with valganciclovir (n = 60) or valacyclovir (n = 59). The primary endpoint was moderate-to-severe interstitial fibrosis and tubular atrophy assessed by protocol biopsy at 3 years evaluated by a single pathologist blinded to the study group. The analysis was conducted in an intention-to-treat population. RESULTS: Among the 101 patients who had a protocol biopsy specimen available, the risk of moderate-to-severe interstitial fibrosis and tubular atrophy was significantly lower in those treated with valganciclovir (22% versus 34%; adjusted odds ratio, 0.31; 95% confidence interval, 0.11-0.90; P = 0.032 by multivariate logistic regression). The incidence of CMV disease (9% versus 2%; P = 0.115) and CMV DNAemia (36% versus 42%; P = 0.361) were not different at 3 years. CONCLUSIONS: Valganciclovir prophylaxis, as compared with valacyclovir, was associated with a reduced risk of moderate-to-severe interstitial fibrosis and tubular atrophy in patients after renal transplantation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12610000016033 ). Registered on September 26, 2007.

Biomedical Centre Faculty of Medicine in Pilsen Charles University 32300 Pilsen Czech Republic

Department of Hemato oncology Teaching Hospital 30460 Pilsen Czech Republic

Department of Internal Medicine 1 Faculty of Medicine in Pilsen Charles University Czech Republic and Teaching Hospital 30460 Pilsen Czech Republic

Department of Pathology Faculty of Medicine in Pilsen Charles University Czech Republic and Teaching Hospital 30460 Pilsen Czech Republic

Division of Information Technologies and Statistics Faculty of Medicine in Pilsen Charles University 32300 Pilsen Czech Republic

Transplant Laboratory Institute for Clinical and Experimental Medicine 14021 Prague Czech Republic

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The Fourth International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation

A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients