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

Autor: Jennifer M. Duchon, Anne A. Gershon, Myron J. Levin
Rok vydání: 2019
Předmět:
Male
Pediatrics
viruses
medicine.disease_cause
varicella
0302 clinical medicine
Pregnancy
postexposure
030212 general & internal medicine
Pregnancy Complications
Infectious
Chickenpox
integumentary system
biology
Incidence (epidemiology)
virus diseases
General Medicine
AcademicSubjects/MED00290
Infectious Diseases
In utero
Child
Preschool
Female
Patient Safety
Post-Exposure Prophylaxis
Infant
Premature
Adult
Hyperimmune globulin
medicine.medical_specialty
030231 tropical medicine
Herpes Zoster
03 medical and health sciences
medicine
Humans
Adverse effect
business.industry
Immune Sera
Infant
Newborn
Varicella zoster immune globulin
Varicella zoster virus
Infant
Original Articles
medicine.disease
hyperimmune globulin
Infectious Disease Transmission
Vertical
Pneumonia
Pediatrics
Perinatology and Child Health
biology.protein
passive immunization
AcademicSubjects/MED00670
preterm
business
Zdroj: Journal of the Pediatric Infectious Diseases Society
ISSN: 2048-7207
DOI: 10.1093/jpids/piz070
Popis: 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.
Infants born prematurely or to women who develop varicella zoster virus ≤5 days before or ≤48 hours after delivery and who were treated with varicella zoster immune globulin (VARIZIG) had a low incidence of varicella and varicella-related morbidity, regardless of administration
Databáze: OpenAIRE
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