Neonatal Herpes Simplex Virus Infection Can Be Treated With Acyclovir
The results from a recent clinical trial led to a label expansion for an adult antiviral for the treatment of herpes simplex virus (HSV).
Based on this study’s data, newborn infants up to 3 months of age, who are infected with HSV, can now be treated with Acyclovir.
This is important news since newborns can become infected with the herpes virus during pregnancy, labor, delivery or shortly after birth if the mother develops genital herpes near the end of her pregnancy.
An HSV infection in newborns can cause death or long-term problems, such as blindness and damage to the brain, says the NIH. Manifestations of neonatal HSV generally occur between the 1st and 3rd weeks of life.
As an example of post-delivery infection, a previous meta-study reviewed 6 published studies which documented HSV-1 infection in neonatal males after circumcision with direct oral suction. One study described 11 cases in New York City and estimated a statistically significant risk ratio associated with oral suction based on 5 of those cases.
The data that informed this label change came from a study funded by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Results from these studies provide information on the most appropriate use of these therapies and may inform an update to the drug’s label by the U.S. Food and Drug Administration.
Perdita Taylor-Zapata, M.D., program lead for the Best Pharmaceuticals for Children Act (BPCA) at NICHD, said in a press release, “With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients.”
NICHD’s BPCA program supports the Pediatric Trials Network (PTN), which studies drugs and therapies commonly prescribed for infants and children but never specifically tested in them.
Results from the PTN study that generated data for Acyclovir’s label change is available online at NICHD’s Data and Specimen Hub.
For more information, visit NICHD’s website.
For more information about NIH and its programs, visit NIH.
Note: Historically, Acyclovir has been prescribed to adults. It will not cure herpes however, it does help relieve the pain and discomfort and helps the sores, if any, heal faster, says this National Institutes of Health (NIH) press release.
- Acyclovir labeling now includes details for treating premature infants infected with herpes virus
- Safety and Efficacy of High-Dose Acyclovir in Infants with HSV or Suspected HSV (BPCA ACY02)
- Genital Herpes - CDC Fact Sheet
- Guidance on Management of Asymptomatic Neonates Born to Women With Active Genital Herpes Lesions
- Neonatal Herpes Simplex Virus Type 1 Infection and Jewish Ritual Circumcision With Oral Suction: A Systematic Review