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Article: Similar reduction of cytomegalovirus DNA load by oral valganciclovir and intravenous ganciclovir on pre-emptive therapy after renal and renal-pancreas transplantation.

Kalpoe, Joyant S / Schippers, Emile F / Eling, Yoav / Sijpkens, Yvo W / de Fijter, Johan W / Kroes, Aloys C M

Antiviral therapy

2005  Volume 10, Issue 1, Page(s) 119–123

Abstract: Background: Pre-emptive treatment of CMV infection in transplant recipients aims at prevention of clinical disease by early detection. However, current treatment requires the intravenous (iv) administration of ganciclovir for 2 weeks, which is a ... ...

Abstract Background: Pre-emptive treatment of CMV infection in transplant recipients aims at prevention of clinical disease by early detection. However, current treatment requires the intravenous (iv) administration of ganciclovir for 2 weeks, which is a considerable burden for the patient. In this observational study, the efficacy of the new oral prodrug valganciclovir was compared with iv ganciclovir.
Methods: To facilitate the introduction of valganciclovir, a therapeutic guideline was developed to use this drug under controlled conditions with regard to safety in renal/renal-pancreas transplant recipients requiring CMV therapy. Subsequently, a group of 57 consecutive transplant recipients was evaluated. Onset and treatment of CMV infections were followed by frequent monitoring of CMV DNA in plasma by quantitative real-time PCR. Details of antiviral therapy were documented.
Results: In 15 out of 57 transplant recipients, a total of 27 anti-CMV treatment episodes were recorded: 18 with valganciclovir (900 mg twice daily) and nine with iv ganciclovir (5 mg/kg twice daily) as initial treatment. Median CMV DNA load reduction during treatment was 0.12 log10/day in the valganciclovir group and 0.09 log10/day in the ganciclovir group. There were no haematological side effects in any group and no patient developed signs of clinical CMV disease.
Conclusion: Similar reduction of CMV DNA load was observed during pre-emptive treatment with oral valganciclovir and iv ganciclovir in transplant recipients. Oral valganciclovir would provide an attractive and safe alternative for pre-emptive CMV treatment in renal/renal-pancreas transplant patients, however, confirmation in larger randomized studies would be desirable.
MeSH term(s) Administration, Oral ; Adult ; Aged ; Antiviral Agents/administration & dosage ; Cytomegalovirus/drug effects ; Cytomegalovirus/genetics ; Cytomegalovirus Infections/drug therapy ; Cytomegalovirus Infections/prevention & control ; Cytomegalovirus Infections/virology ; DNA, Viral/blood ; DNA, Viral/genetics ; Female ; Ganciclovir/administration & dosage ; Ganciclovir/analogs & derivatives ; Humans ; Injections, Intravenous ; Kidney Transplantation/adverse effects ; Male ; Middle Aged ; Opportunistic Infections/drug therapy ; Opportunistic Infections/prevention & control ; Opportunistic Infections/virology ; Pancreas Transplantation/adverse effects ; Safety
Chemical Substances Antiviral Agents ; DNA, Viral ; valganciclovir (GCU97FKN3R) ; Ganciclovir (P9G3CKZ4P5)
Language English
Publishing date 2005
Publishing country England
Document type Clinical Trial ; Comparative Study ; Journal Article
ZDB-ID 1339842-8
ISSN 1359-6535
ISSN 1359-6535
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