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Pol. Merkur. Lek (Pol. Med. J.), 2013, XXXV/205: 010-013 Maximize

Pol. Merkur. Lek (Pol. Med. J.), 2013, XXXV/205: 010-013

Title: Clinical efficacy and safety of prolonged use of the valganciclovir for the treatment of cytomegalovirus disease in patients after kidney transplantation 

Authors: Kawalec P., Szkultecka-Dębek M., Maks J., Paszulewicz A., Kawęczyńska-Lasoń A., Pilc A.

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02/205

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SUMMARY IN POLISH & ENGLISH. FULL ARTICLE ONLY IN POLISH.

Clinical efficacy and safety of prolonged use of the valganciclovir for the treatment of cytomegalovirus disease in patients after kidney transplantation


Kawalec P.1,2, Szkultecka-Dębek M.3, Maks J.2, Paszulewicz A.2, Kawęczyńska-Lasoń A.3, Pilc A.1,4

1Jagiellonian University of Cracow, Poland, Faculty of Health Sciences, Institute of Public Health, Department of Drug Management; 2Centre HTA Sp. z o.o. Sp. k. in Cracow, Poland; 3Roche Polska Sp. z o.o. in Warsaw, Poland; 4Polish Academy of Sciences, Institute of Pharmacology in Cracow, Poland

Cytomegalovirus infection is particularly dangerous for patients undergoing solid organs transplantation. Among these patients cytomegalovirus disease (CMV) may occur. CMV disease is associated with increased mortality, organ damage and reduced graft survival.
The aim of the study
was to determine the clinical outcomes (clinical efficacy and safety profile) for the use of valganciclovir administered for 200 days compared to standard period of 100 days in the prevention of cytomegalovirus disease in seronegative patients after kidney transplantation from infected donor (high risk patients).
Material and methods
. A systematic review of literature published during the period: 1st January 1966 – 31st October 2010, was performed in order to assess the efficacy and safety of valganciclovir in the treatment of cytomegalovirus disease. Databases MEDLINE (PubMed), EMBASE and Cochrane were searched.
Results
. A systematic review yielded 1 randomized and 3 nonrandomized clinical trials. 200 days prophylaxis with valganciclovir significantly decreased a risk of: cytomegalovirus disease, CMV viral load, opportunistic infections; percentage of patients with high viral load was also significantly decreased compared to 100 days therapy. The safety profile of extended therapy was similar to that observed within 100 days prophylaxis. The higher risk of leucopenia in the 200 days than 100 days group was the only one adverse event that met statistical significance. The results of non-randomized trials were comparable to those mentioned above.
Conclusion
. Prolonged prophylaxis of cytomegalovirus till 200 days in high-risk patients (D+/B-) is safe and provides significant therapeutic benefits.

Key words: CMV, cytomegalovirus disease, kidney transplantation, valganciclovir

Pol. Merk. Lek., 2013, XXXV, 205, 10