The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group has found that treatment with the anti-viral medication valganciclovir for six months improves hearing and developmental outcomes over a two-year period for infants with congenital cytomegalovirus (CMV) infection. Roberta L. DeBiasi, MD, MS, Chief of the Division of Pediatric Infectious Diseases, Children's National Health System, is co-author of the study published in the New England Journal of Medicine.
Congenital CMV infection is a condition that can occur when a pregnant mother suffers a primary or reactivated infection. It is the most common congenital infection worldwide, affecting about one percent of all births in the US, and the most common cause of sensorineuronal deafness.
A total of 10 percent of congenitally infected neonates have symptoms of the disease at birth, of whom 35 percent have sensorineuronal hearing loss and up to two-thirds have neurologic deficits such as intellectual disability, seizures, or paresis/paralysis.
The medication, valganciclovir, has been deemed safe and effective for babies, is administered by mouth, and resulted in improved hearing and neurodevelopmental outcomes measured at one and two years of age when given for six months.
With the availability of oral valganciclovir, "a child won't have to be in a hospital with an intravenous catheter for six weeks," Dr. DeBiasi says. "With this treatment, you can have the baby at home, and a normal newborn situation. We see the patients in our outpatient clinic to follow their exam and lab testing closely, but they can live a normal home life. It gives the parents a lot of hope."
"Compared with patients who received shorter therapy, patients who received longer therapy had 3.0 times the odds of having improved hearing or protection of normal hearing at 12 months and 2.6 times the odds at 24 months," Dr. DeBiasi and co-authors wrote in the study.
Six months of therapy resulted in significantly higher scores for achievement of neurodevelopmental milestones related to infants' language and communication abilities, and also a trend for higher scores for milestones related to fine and gross motor skills, Dr. DeBiasi says.
By having the option to give the antiviral medicine orally, it is a much greater convenience for parents and families, Dr. DeBiasi says. Previously, the study group found that a related antiviral drug, ganciclovir, which was given intravenously over a 6-week period, also was associated with improved hearing outcomes compared to no treatment, but there were side effects, and the babies had to stay in a hospital.
The studies reflect overall improvements in pharmacological treatments for congenital CMV, noting "less than 15 years ago there was no studied treatment for congenital CMV," Dr. DeBiasi says.
"Since 90 percent of infected infants have no symptoms at birth, a large proportion of parents never know their baby is infected; they are completely well at birth, but can then be found to have a hearing or developmental deficit later," she adds.
"This study doesn't show that the drug can prevent all hearing and developmental deficits, but we can determine if longer treatment might result in even better outcomes for these babies," Dr. DeBiasi says.