TREATMENT OF CMV INFECTION OR DISEASE IN SOLID ORGAN TRANSPLANT PATIENTS WITH VALGANCICLOVIR

Abstract

P810 Background: Valganciclovir (VGC) is a valyl ester of ganciclovir with much improved oral biodisponibility. It has proved successful for the prophylaxis against Cytomegalovirus (CMV) in high risk transplant recipients (CMV serostatus D+/R-), and for the treatment of newly diagnosed CMV retinitis in AIDS patients. We have recently used VGC for the treatment of CMV infection (viremia without symptoms) or disease (CMV syndrome or tissue-invasive disease) in kidney and lung transplant recipients. Methods: In 2003, 10 transplant recipients (7 kidney and 3 lung) were treated between 6 to 26 weeks after transplantation. CMV serostatus was D+/R- (n=7), D+/R+ (n=2), and D-/R+ (n=1). Three patients had received valaciclovir and 5 patients VGC prophylaxis during the first 3 months after transplantation. Four patients were treated for CMV infection and 6 for CMV disease (hepatitis n=1, colitis n=2, pneumonia n=1, CMV syndrome n=2). VGC was administered for 2 to 3 weeks (900 – 1800 mg per day, according to the renal function), followed by 2 to 4 weeks of secondary prophylaxis (450 – 900 mg per day, according to the renal function). Results: Clinically, all 6 symptomatic patients were cured. Microbiologically, treatment with VGC turned blood culture negative for CMV within 2 weeks in 10/10 patients, and was associated with a 2 log decrease in blood CMV DNA within 2 weeks in 3/3 tested patients. With a follow-up of 6 months, asymptomatic recurrent CMV viremia was noted in 5 cases, and CMV syndrome in one case. VGC was well tolerated in all patients, however an increase in transaminases was observed after 4 weeks of therapy in one case. Conclusions: Our preliminary experience strongly suggests that VGC is safe and effective to treat CMV infection/disease in organ transplant recipients, however the exact duration of therapy remains to be determined.