Oral acyclovir lowered risk for developmental delays in infants with HSV

VANCOUVER — Infants with herpes simplex virus treated with suppressive oral acyclovir therapy for 6 months were less likely to suffer from neurodevelopmental outcomes and had fewer skin lesion recurrences when compared with those assigned placebo, according to new study findings presented by David W. Kimberlin, MD.

“Infants assigned [acyclovir] had fewer developmental delays when compared with infants not assigned the drug,” Kimberlin, of the University of Alabama at Birmingham, and an Infectious Diseases in Children Editorial Board member, said during a press conference at the 48th Annual Meeting of the Infectious Disease Society of America held here.

Although neonatal HSV is rare and significant improvements have been made in management of the disease, most improvements have been made in mortality only, not morbidity, according to Kimberlin. “Therefore, infants who survived the disease had damaged brains and difficulty meeting developmental milestones.”

For this reason, the Kimberlin and colleagues conducted two identical, parallel, phase 3 double-blind, placebo-controlled trials including 74 infants with central nervous system disease (n=45) or skin, eye, mouth disease (n=29).

Infants were randomly assigned to 300 mg/m² oral acyclovir suppression three times daily for 6 months or placebo. Cutaneous recurrences were treated; blinded study medication was discontinued and acyclovir was administered in infants with a second skin recurrence.

Compared with infants assigned placebo, infants with central nervous system disease assigned to treatment had significantly higher mean Bayley Scales of Infant Development Mental Scores at 1 year (68.12 vs. 88.24; P=.046).

The researchers noted that the time to blinded study medication discontinuation was >2 months longer for infants treated with acyclovir vs. placebo (P=.009). Moreover, neutropenia incidence and degree did not differ between the two groups.

Disclosure: Dr. Kimberlin’s institution, The University of Alabama, receives payment for participation in clinical trials sponsored by GlaxoSmithKline, Cellex and Cubist. He is also an Infectious Diseases in Children Editorial Board member

When we think of neonatal HSV, we are thinking of one major problem, and that is neurological impairment in children who have the disease. This is one of the most stressing of all circumstances for a couple and the recurrence of skin vesicles is a reminder to the couple that they gave this disease to their baby. One of the offshoots of this study would be to look prospectively at whether or not this improves the well-being of the relationship between the parents, because they won’t see the recurrence of the lesions. A second component of this is that the 3 month-old who is in day care is taken out of day care as soon as they have a lesion , which means parents will lose time away from work. I am sure that Dr. Kimberlin’s group will look further into this down the road.

–Richard Whitley, MD

President, IDSA
Director of the Division of Pediatric Infectious Diseases,
University of Alabama, Birmingham

For more information:

Kimberlin DW. #810. Presented at: the IDSA 48th Annual Meeting; Oct. 21-24, 2010; Vancouver, B.C.