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Valganciclovir prophylaxis for CMV infection in thoracic transplant patients

Abstract number: P1779

Lefeuvre S., Guillemain R., Zekkour R., Berge M., Amrein C., Boussaud V., Charpentier C., Chevalier P., Billaud E.M.

Cytomegalovirus (CMV) infection is a very common opportunistic infection after solid organ transplantation. Intravenous Valganciclovir (vGCV), an haematotoxic drug with renal elimination pathway, remains the first-line treatment for CMV disease. Due to its poor bioavailability, oral GCV was replaced by an oral prodrug valganciclovir (vGCV) for prophylaxis.

Objectives: We analyzed In a retrospective study, the efficacy and safety of vGCV during and for 4 months after discontinuation of prophylaxis in heart (HT) and lung transplant patients with (CFLT) cystic fibrosis or not (LT).

Methods: Selected patients were HT, LT and CFLT, with a stable renal function (RF) receiving 900 mg vGCV daily for preventing CMV disease between 2005 and 2007. Prophylaxis was introduced in the early post transplantation period during respectively 3 to 6 months in HT and to 12 months in CFLT and LT. Donor (D) and recipient (R) CMV serostatus were collected. A GCV therapeutic drug monitoring (TDM) was realised to document efficient concentrations in the 0.5–1.5 mg/L range. Plasma GCV trough levels were measured by UV-LC assay. Moreover, efficacy was checked by pp65 antigenaemia (Ag) detection in peripheral blood leukocytes.

Results: 32 thoracic transplants (11 HT, 7 LT, 14 CFLT) were included into the study. CMV serostatus distribution was 53% D+/R-, 25% D-/R+ and 22% D+/R+. vGCV was maintained for 106±67 days in case of HT versus 270±85 days for LT and CFLT. 300 determinations of GCV through concentrations have been performed, representing 7 to 12 samples per patient. HT, LT and CFLT have received respectively 700±225, 915±60 and 820±150 mg per day, resulting in mean GCV trough level of 0.75±0.5 mg/L. Lower doses registered in HT were adapted to RF. The safety data indicated that 9 neutropenia were recorded but only 2 were attributable to vGCV. Three D+/R- CFLT patients presented a positive pp65 Ag, 1 during the vGCV prophylaxis and 2 within the 4 months after discontinuation. 2 patients developed CMV disease, corresponding to an incidence of 6%.

Conclusion: 900 mg vGCV daily, adapted to RF appeared effective and safe for long CMV prophylaxis, related to efficient exposure to GCV in thoracic transplant patients. These first results also confirmed that a regular TDM is not necessary in case of oral vGCV prophylaxis for patients with stable RF.

Session Details

Date: 16/05/2009
Time: 00:00-00:00
Session name: 19th European Congress of Clinical Microbiology and Infectious Diseases
Subject:
Location: Helsinki, Finland, 16 - 19 May 2009
Presentation type:
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