A Multicenter Study of Valganciclovir Prophylaxis up to Day 120 in CMV‐Seropositive Lung Transplant Recipients

Seventy‐six cytomegalovirus (CMV)‐seropositive lung transplant recipients receiving valganciclovir (900 mg/day) for CMV prophylaxis were compared with a group of 87 patients receiving oral ganciclovir (3000 mg/day). Prophylaxis was administered to day 120 post‐transplantation and follow‐up was 1 yea...

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Published in:American journal of transplantation 2009-05, Vol.9 (5), p.1134-1141
Main Authors: Monforte, V., Lopez, C., Santos, F., Zurbano, F., De La Torre, M., Sole, A., Gavalda, J., Ussetti, P., Lama, R., Cifrian, J., Borro, J. M., Pastor, A., Len, O., Bravo, C., Roman, A.
Format: Article
Language:English
Subjects:
Adult
Antiviral Agents - adverse effects
Antiviral Agents - therapeutic use
Bacterial Infections - epidemiology
Basiliximab
Biological and medical sciences
Cytomegalovirus
Cytomegalovirus Infections - drug therapy
Cytomegalovirus Infections - epidemiology
Cytomegalovirus Infections - prevention & control
Female
Follow-Up Studies
ganciclovir
Ganciclovir - adverse effects
Ganciclovir - analogs & derivatives
Ganciclovir - therapeutic use
Graft Rejection - epidemiology
Histocompatibility Testing
Humans
Infectious diseases
Leukopenia - chemically induced
Leukopenia - epidemiology
Lung Diseases - classification
Lung Diseases - surgery
lung transplantation
Lung Transplantation - physiology
Male
Medical sciences
Middle Aged
Prevention and actions
prophylaxis
Public health. Hygiene
Public health. Hygiene-occupational medicine
Safety
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Valganciclovir
Viral diseases
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Summary:Seventy‐six cytomegalovirus (CMV)‐seropositive lung transplant recipients receiving valganciclovir (900 mg/day) for CMV prophylaxis were compared with a group of 87 patients receiving oral ganciclovir (3000 mg/day). Prophylaxis was administered to day 120 post‐transplantation and follow‐up was 1 year. In addition, a study was conducted on risk factors for CMV infection/disease. CMV disease incidence was 7.9% and 16.1% for valganciclovir and oral ganciclovir, respectively (p = 0.11). Patients receiving valganciclovir had fewer viral syndromes (2.6% vs. 11.5%, p < 0.05), a similar rate of tissue‐invasive disease (5.2% vs. 4.6%, p = ns), longer time‐to‐onset of CMV infection/disease (197.5 vs. 155.2 days, p < 0.05), and a lower probability of infection/disease while on prophylaxis (1.3% vs. 12.6%, p < 0.01). Nonetheless, leukopenia incidence was higher with valganciclovir (15.8% vs. 2.3%, p < 0.01), as was the need for treatment withdrawal due to adverse effects (11.8% vs. 1.1%, p < 0.01). CMV infection was similar in both groups (32.9% vs. 34.5%). Induction therapy with basiliximab and glucocorticosteroid treatment were independent risk factors for developing CMV infection/disease. In conclusion, valganciclovir prophylaxis results in a low incidence of CMV disease in lung transplant recipients and appears more effective than oral ganciclovir. Despite the comparatively higher incidence of adverse events with valganciclovir, the drug can be considered safe for prophylaxis. Valganciclovir prophylaxis results in a low incidence of CMV disease and appears more effective than oral ganciclovir.
ISSN:1600-6135
1600-6143
DOI:10.1111/j.1600-6143.2009.02574.x