COMPLICATIONS - INFECTIONS

F. Saliba¹, R. Guillemain², A. Fourrier³, N. Tagieva⁴, C. Legendre^5
1Centre Hepato-biliaire, AP-HP Hopital Paul Brousse, Villejuif/FRANCE, ²Thoracic Transplantation, European Georges Pompidou Hospital, Paris 8/FRANCE, ³, Inserm U 657, Bordeaux/FRANCE, ⁴Medical Affaires, Roche, Neuilly sur Seinne/FRANCE, ⁵, Université Paris Descartes & Hôpital Necker, Paris/FRANCE

Body: Cytomegalovirus (CMV) remains one of the most common pathogens to affect the solid-organ transplant (SOT) recipient through direct or indirect effects. ORVAL, a large cohort of SOT patients, aimed todescribe the targeted population receiving valganciclovir (VGCV) to prevent CMV infection with regard to treatment regimens, both length and dosage adjustment to renal function.

Adult patients who received a single or a combined live or cadaveric organ allograft less than 6 months post-transplantation were included in the study at the time of VGCV treatment initiation. Thisdescriptive analysis includes 440 patients and their 3 month follow-up, and consists of 245 kidney (55.7%), 87 liver (19.8%), 63 heart (14.3%), 36 lung (8.2%), 9 combined (2.0 %) recipients. Thedonor-recipient CMV serostatus was represented similarly by D+/R- (n=151, 35.4%) and D+/R+ (n=145, 34.0%), then by D-/R+ (n=116, 27.2%) and D-/R- (n=14, 3.3%). 71.4% patients received VGCVprophylaxis, 20.4% recipients were initiated on pre-emptive therapy, and 8.2% recipients initiated VGCV as the treatment of CMV disease. Patients on prophylaxis comprised of 127D⁺/R^-, 173 - R⁺ and 8 - D^-/R^-. Data available for these patients show that VGCV prophylaxis dosage is based upon the renal function at inclusionin 148/282 recipients (52.5%) and in 134/256 (52.3%) - at follow-up visit. 21 of 440 patients experienced CMV infection/disease during the follow-up period of which 15 patients (4.7%) receivingprophylaxis. VGCV dosage was adjusted to kidney function in 6 of them. CMV infection and disease responded to IV ganciclovir and VGCV treatment. Neutropenia (PNN < 1000/mm³) wasobserved in 28 patients receiving prophylaxis (9.0%). Among them, 10 received VGCV dose not adjusted to the creatinine clearance.

Conclusions. Present data indicate that the majority of SOT recipients (71.4%) received VGCV prophylaxis. In only half of them VGCV dosage was adjusted to the renal function at thetreatment initiation and first follow up visit. These data highlight the current challenge to improve VGCV management in SOT recipients in regards to dose adjustment for patients with renalimpairment.

Disclosure: All authors have declared no conflicts of interest.