Medical Professional Publications

Potential Shift in Care for CMV-Infected Neonates

(From the May 2015 Issue of PediatricsOnline)

Newborns with symptomatic congenital cytomegalovirus (CMV) disease treated with oral valganciclovir for six months showed modestly improved hearing and developmental outcomes at 12 months of age, compared to neonates treated for six weeks, according to a study published in the New England Journal of Medicine.

It is imperative to identify babies with the infection because treatment is beneficial, says Pablo Sánchez, MD, a neonatologist and pediatric infectious diseases specialist and principal investigator in the Center for Perinatal Research at The Research Institute at Nationwide Children's Hospital and an author of the study.

"Longer treatment of neonates with clinical, laboratory or radiographic abnormalities of congenital CMV infection is likely to be the new recommendation," says Dr. Sánchez, who is also a professor of Pediatrics at The Ohio State University College of Medicine.

The study was done by the Collaborative Antiviral Study Group (CASG) at 31 sites, building on earlier work showing that six weeks of treatment with intravenous ganciclovir in neonates with congenital CMV infection involving the central nervous system improved hearing outcomes in these infants. Dr. Sánchez participated in the study while at the University of Texas Southwestern Medical Center in Dallas.

Congenital CMV infection affects about 0.4 to 1 percent of all newborns worldwide and is the most common nongenetic cause of hearing loss in childhood, accounting for 5-8 percent of neonates with hearing loss at birth. This chronic disease is also the leading viral cause of mental retardation.

The Centers for Disease Control and Prevention estimates that more than 5,000 children in the United States suffer permanent damage from CMV annually. The disease also may cause vision loss, seizures, problems in the liver, spleen and lungs and, ultimately, neurodevelopmental impairment with disabilities.

In this study, 96 neonates were given valganciclovir orally for six weeks and, after a random draw, half continued receiving the antiviral drug and half received a placebo during the next 4.5 months.

At six months, the researchers found no statistical difference in hearing outcomes between the groups. But in follow-up assessments at one year, 73 percent of those who received longer treatment either maintained normal hearing or had improved hearing, compared to 57 percent of those who received the placebo after the shorter treatment. After two years, the difference was 77 percent compared to 64 percent.

During the two-year assessment, the group treated for six months also showed better neurodevelopment than the group treated for six weeks, scoring higher on portions of the Bayley Scales of Infant and Toddler Development.

At each assessment, children who received longer treatment had lower viral loads in whole blood.

Though beneficial, valganciclovir is associated with neutropenia, or low neutrophil count, normally the most numerous type of white blood cells in the circulation. At six weeks, 19 percent of the children had neutropenia, compared to 63 percent of participants who received intravenous treatment in the earlier study, indicating reduced risk with oral treatment.

Dr. Sánchez continues investigating the disease at Nationwide Children's and The Ohio State University.

Pediatricians need to know about the findings, Dr. Sánchez says. "We're treating infants longer. The study has had an impact on the care of these infants. But we must identify them first in order to provide them the benefits!"


Kimberlin DW, Jester PM, Sánchez PJ, Ahmed A, Arav-Boger R, Michaels MG,  Ashouri N, Englund JA, Estrada B, Jacobs RF, Romero JR, Sood SK, Whitworth MS, Abzug MJ, Caserta MT, Fowlers S, Lujan-Zilbermann J, Storch GA, DeBlasi RL, Han JY, Palmer A, Weiner LB, Bocchini JA, Dennehy PH, Finn A, Griffiths PD, Luck S, Gutierrez K, Halasa N, Homans J, Shane AL, Sharland M, Simonsen K, Vanchiere JA, Woods CR, Sabo DL, Aban I, Kuo H, James SH, Prichard, MN, Griffin J, Giles D, Acosta EP, Whitley RJ; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Valganciclovir for symptomatic congenital cytomegalovirus disease. New England Journal of Medicine. 2015 March 5, 372(10):933-943.

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