Long-term oral ganciclovir prophylaxis for prevention of cytomegalovirus infection and disease in cytomegalovirus high-risk renal transplant recipients.
BACKGROUND
Although specific therapy is available with ganciclovir, cytomegalovirus (CMV) disease remains a major problem after renal transplantation especially in CMV seronegative recipients of organs of seropositive donors (D+R-).


METHODS
In an open-labeled prospective controlled trial we evaluated the effect of long-term oral ganciclovir prophylaxis (3 g/day for 3 months posttransplantation) in a cohort of 31 CMV-high risk (D+R-) renal transplant recipients (GC) compared with a cohort of 28 high-risk patients with targeted CMV prophylaxis (CO) receiving i.v. ganciclovir during antirejection therapy. Primary end-points were CMV infection, diagnosed by pp65 antigenemia assay or serologic method, and CMV disease. Additionally severity of CMV disease quantified by a scoring system was evaluated.


RESULTS
CMV prophylaxis significantly reduced the incidence of CMV infection (CO: 75%, GC: 45%; P<.05) and CMV disease (CO: 60%, GC: 29%; P<.05) without relevant side effects and without any clinical suspicion of ganciclovir resistance. Severity of CMV disease as quantified by a scoring system was reduced from 8.3+/-6.7 points in controls to 3.3+/-2.6 points in ganciclovir-treated patients (P<.05). Mortality did not differ significantly between the two groups (CO: n=3, GC: n=1; NS). However, there was one lethal CMV disease and a second death possibly attributable to CMV disease in the control group, whereas in ganciclovir-treated patients there was no CMV-associated fatal outcome.


CONCLUSIONS
Long-term oral ganciclovir prophylaxis is effective and safe in CMV high-risk renal transplant recipients.
Kletzmayr
J
J
Department of Medicine, University of Vienna, Austria. josef.kletzmayr@nephro.imed3.akh-wien.ac.at
Kreuzwieser
E
E
Watkins-Riedel
T
T
Berlakovich
G
G
Kovarik
J
J
Klauser
R
R
D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage*; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors
D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D015774:Ganciclovir