February 12, 2019
1 min read

Acyclovir labeling now includes premature infants with HSV

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Photo of Perdita Taylor-Zapata
Perdita Taylor-Zapata

The NIH recently announced that the labeling for the antiviral acyclovir has been updated to include information for health care providers on the recommended usage and dosage in newborns aged 3 months and younger who are infected with herpes simplex virus. The drug is typically prescribed to adults with HSV infections.

The label change is supported by data from a study sponsored by the NIH Best Pharmaceuticals for Children Act (BPCA) program at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The study “provides valuable and updated dosing and safety information on the use of this medication in a most vulnerable population — preterm newborns,” Perdita Taylor-Zapata, MD, program lead for the PBCA at the NICHD, told Infectious Diseases in Children. “For decades, pediatric data in many medication labels have been limited, with this phenomenon being magnified in the neonatal population. The information from this study will give clinicians more accurate information on the right dose for their patients, along with additional safety data that can be used to monitor the effects of the drug on their patients. “

Although HSV causes genital herpes in adults, the virus can infect newborns during pregnancy, labor and deliver or shortly after birth if the mother develops genital herpes near the end of her pregnancy. The infection in newborns can lead to long-term problems, including blindness and damage to the brain and other organs. The virus can also lead to death, according to the NIH.

The BPCA trial was an observational, retrospective study that analyzed safety data on infants who had been admitted to NICUs and received acyclovir as standard of care for confirmed HSV infection. The sources of the data included the Pediatrix Medical Group database and medical charts from four clinical sites (n = 49). The researchers also reviewed safety data from two major clinical trials of acyclovir in neonatal HSV infection.

The NICHD’s BPCA program supports the Pediatric Trials Network, which studies drugs and therapies that are commonly prescribed for infants and children but were never specifically tested in them, according to the NIH. – by Bruce Thiel


NIH. Safety and efficacy of high-dose acyclovir in infants with HSV or suspected HSV (BPCA ACY02) - 6.23 MB. https://dash.nichd.nih.gov/study/15895. Accessed February 12, 2019.

Disclosure: Taylor-Zapata reports no relevant financial disclosures.