Letter to the Editor
Dear Editor:

Recently, Medscape posted an article by Kathleen Lake entitled "New Prophylactic Strategy for Cytomegalovirus Disease." The article discussed, among other things, the pivotal trial for Valcyte (valganciclovir HCl tablets) in solid organ transplantation (PV16000) and the new FDA-approved valganciclovir HCl label based on the trial. The article, while thorough, omitted the entirety of valganciclovir HCl's new indication and did not highlight the outcomes of the liver transplant subpopulation presented in the label.

We want to ensure that the audience of this article is aware that valganciclovir HCl is indicated for the prevention of cytomegalovirus (CMV) disease in high-risk kidney, heart, and kidney-pancreas transplant recipients (eg, donor CMV-seropositive/recipient CMV-seronegative [(D+/R-)]). Valganciclovir HCl is not indicated for use in liver transplant recipients, and the safety and efficacy of valganciclovir HCl for the prevention of CMV disease in other solid organ transplant recipients, such as lung transplant recipients, have not been established.

In an organ subgroup analysis of PV16000, the liver transplant subpopulation showed a significantly higher incidence of tissue-invasive CMV disease in the valganciclovir HCl-treated group compared with the oral ganciclovir group.

Thank you,
Roche Laboratories