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9/26/2014  |   1:00 PM - 2:00 PM   |  Ballroom A-B

Plenary II
Diagnosis and Treatment of Congenital Cytomegalovirus (CMV) Disease

Congenital CMV infection can result in symptomatic disease at birth, or in asymptomatic infection. Diagnosis of symptomatic CMV disease is relatively straightforward, since those patients have manifestations that drive the diagnostic approach. Conversely, diagnosis of asymptomatic CMV infection can only be achieved through broad-based screening programs since those patients are normal in appearance. Data on the treatment of congenital CMV infection are only available for babies with symptomatic disease. A randomized controlled trial conducted in the 1990s by the Collaborative Antiviral Study Group (CASG) demonstrated that six weeks of intravenous ganciclovir to babies with symptomatic congenital CMV disease protects against hearing deterioration over the first six months of life. The dose of oral valganciclovir that produces similar blood concentrations of ganciclovir as does intravenous ganciclovir was identified in a subsequent CASG trial. Recently, CASG completed a multicenter study in the U.S. and the U.K. that assessed whether six months of oral valganciclovir therapy results in better hearing and neurodevelopmental outcomes than six weeks of oral valganciclovir therapy. This study did not demonstrate a difference in hearing outcomes at 6 months between the shorter and longer treatment groups, but some measures of hearing improved at 12 and 24 months among those subjects receiving six months of antiviral therapy compared with six weeks of treatment. Neurodevelopmental outcomes were also improved at 24 months in the group receiving the longer course of treatment. The main toxicity of ganciclovir or valganciclovir is neutropenia, but in the infant population oral valganciclovir produces lower rates of neutropenia than does intravenous ganciclovir. In animal models, ganciclovir is carcinogenic and gonadotoxic, these toxicities have not been seen in humans. Based upon the CASG trials, only infants with symptomatic congenital CMV disease should be considered for antiviral therapy. Patients should be monitored for toxicity throughout the treatment period.

David Kimberlin (Primary Presenter), dkimberlin@uab.edu;
Dr. Kimberlin holds the Sergio Stagno Endowed Chair in Pediatric Infectious Diseases at the University of Alabama at Birmingham, where he is Co-Director of the Division of Pediatric Infectious Diseases. Dr. Kimberlin is Principal Investigator of the Collaborative Antiviral Study Group (CASG) who are contracted to evaluate novel therapeutic and diagnostic opportunities for management of neonatal herpes simplex virus (HSV) disease and congenital cytomegalovirus (CMV) infection. Among other commitments, Dr. Kimberlin is the AAP Red Book liaison to the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), President of the Pediatric Infectious Diseases Society (PIDS), and Director of Subspecialty Medical Education for the UAB Department of Pediatrics. He has received numerous education awards, including the 2003 Ralph E. Tiller, M.D., Distinguished Faculty Award, recognizing the faculty member that the Senior Pediatric Resident class believes has contributed the most to their overall education and training experience.


Financial - Receives Grants,Other financial benefit for Independent contractor from GSK.   Receives Grants,Other financial benefit for Independent contractor from Gilead.  

Nonfinancial - No relevant nonfinancial relationship exist.


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