Is oral treatment of CMV-infections with valganciclovir after heart transplantation sufficient?

Abstract

Background: CMV-infection and CMV-disease is a common adverse event after heart transplantation (HTx). Todate oral formulations of virostatics had a limited bioavailability. Therefore state of the art therapy of CMV-infections used to be intravenous application of ganciclovir. Patients had to be hosptalized and intravenous application was associated with the risk of catheter-related complications. Methods: In this study 12 patients after HTx with manifest CMVinfections were treated with the new oral formulation of ganciclovir (Valcyte), a valylester prodrug of ganciclovir, achieving similar plasma concentrations when compared to intravenous treatment. CMVinfection was defined as positive CMV-Clonab(pp65) or positive CMV-PCR. Valcyte was adminstered according to creatinine clearance until PCR or Clonab proved to be negative (at least for two weeks). During treatment patients were screened every second day, using venous blood sampling and measurement of PCR and Clonab(pp65). Results: Survival during follow up was 100%. All patients tolerated the medication well, only one patient showed leucopenia and medication had to be stopped. Mean duration of administration was 50,3 days with a mean dosis of 231,7 712 mg/d; in all patients the infections were treated effectively. Creatinine levels, glutamate-oxalacetate-transaminase, glutamat-pyruvate-transaminase did not increase significantly during follow up. Conclusion: The findings of these study indicate that the oral formulation of ganciclovir is an effective alternative for treating CMV-infections after HTx. It is well tolerated and avoids the risk of catheter-related complications, associated with long term daily intravenous therapy administration as well as the costs for hospitalization.