Safety and Varicella Outcomes in In Utero-Exposed Newborns and Preterm Infants Treated With Varicella Zoster Immune Globulin (VARIZIG): A Subgroup Analysis of an Expanded-Access Program.

Abstract

BACKGROUND:

Infants exposed to varicella zoster virus (VZV) in utero ≤5 days before or ≤48 hours after delivery and preterm infants are at high risk for varicella complications. An expanded-access program assessed varicella outcomes after administration of varicella zoster immune globulin (human) (VARIZIG) in a real-world setting.

METHODS:

In this open-label, expanded-access program, high-risk infants received ≤125 IU/10 kg of VARIZIG (NCT00338442). VZV outcomes and safety were assessed.

RESULTS:

There were 43 newborns exposed to VZV in utero and 80 preterm infants exposed to VZV; >80% received VARIZIG within 96 hours of reported exposure. When varicella outcomes were available, varicella occurred in 7 of 38 (18%) in utero-exposed newborns and zero of 65 preterm infants. Varicella-related complications were reported in 3 in utero-exposed newborns (3 with >100 lesions, 1 each with encephalitis and pneumonia). Adverse events were reported for 16% of in utero-exposed newborns and 25% of preterm infants, but few were considered related to VARIZIG. There were no deaths attributable to varicella or VARIZIG.

CONCLUSIONS:

Varicella incidence and morbidity were low in in utero-exposed infants and zero in preterm infants who received prophylactic VARIZIG. There were few VARIZIG-related safety concerns.

• Authors: Jennifer M Duchon, Myron J Levin, Anne A Gershon
• Journal: Journal of the Pediatric Infectious Diseases Society (J Pediatric Infect Dis Soc) Vol. 9 Issue 4 Pg. 449-453 (Sep 17 2020) ISSN: 2048-7207 [Electronic] England
• PMID: 31774916 (Publication Type: Journal Article)
• Copyright: © The Author(s) 2019. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society.

Chemical References

• Immune Sera
• varicella-zoster immune globulin

Topics

• Adult
• Child, Preschool
• Female
• Herpes Zoster (immunology, prevention & control)
• Humans
• Immune Sera (adverse effects, immunology)
• Infant
• Infant, Newborn
• Infant, Premature
• Infectious Disease Transmission, Vertical
• Male
• Patient Safety
• Post-Exposure Prophylaxis
• Pregnancy
• Pregnancy Complications, Infectious (immunology)