title: Similar reduction of cytomegalovirus DNA load by oral valganciclovir and intravenous ganciclovir on pre-emptive therapy after renal and renal-pancreas transplantation.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands. J.S.Kalpoe@lumc.nl
authors.forename: Joyant S
authors.initials: JS
authors.lastname: Kalpoe
authors.forename: Emile F
authors.initials: EF
authors.lastname: Schippers
authors.forename: Yoav
authors.initials: Y
authors.lastname: Eling
authors.forename: Yvo W
authors.initials: YW
authors.lastname: Sijpkens
authors.forename: Johan W
authors.initials: JW
authors.lastname: de Fijter
authors.forename: Aloys C M
authors.initials: AC
authors.lastname: Kroes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D003587:Cytomegalovirus / Q000187:drug effects* / Q000235:genetics; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000821:virology; D004279:DNA, Viral / Q000097:blood* / Q000235:genetics; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006801:Humans; D007275:Injections, Intravenous; D016030:Kidney Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000188:drug therapy / Q000517:prevention & control / Q000821:virology; D016035:Pancreas Transplantation / Q000009:adverse effects; D012449:Safety; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D000077562:Valganciclovir; D015774:Ganciclovir