New Data Shows Frequent ICU Admissions from Severe RSV Disease among Preterm Infants in the First Three Months of Life

SENTINEL1 Respiratory Syncytial Virus (RSV) Data presented at IDWeek
2016

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced data from the second season of its SENTINEL1
study, the largest study ever to examine laboratory-confirmed
respiratory syncytial virus hospitalizations (RSVH) among US preterm
infants 29-35 weeks gestational age (wGA) who were <12 months of age at
the time of their RSVH admission.1,2 Infants enrolled did not
receive immunoprophylaxis (IP) within 35 days before the onset of RSV
disease symptoms during the 2014-2015 or 2015-2016 RSV seasons.1,2
Study results were presented at IDWeek 2016 in New Orleans, LA.

RSV is a leading cause of hospitalization for babies in the US during
their first year of life, creating a high unmet medical need, especially
among high-risk infants.3

At the 42 hospitals involved in the study during the 2015-2016 RSV
season, 678 infants were found to have been hospitalized with
community-acquired RSV, and 78% of these infants were <6 months of age
when hospitalized.2

Among those hospitalized, intensive care unit (ICU) admission was
required for 48% of infants and invasive mechanical ventilation (IMV)
was required for 19% of infants.2 ICU admission and IMV were
most frequent in infants ❤ months of age.2

  • Among infants 29-32 wGA and ❤ months, 69% were admitted to the ICU
    and 36% required IMV2
  • Among infants 33-34 wGA and ❤ months, 60% were admitted to the ICU
    and 30% required IMV2
  • Among infants 35 wGA and ❤ months, 53% were admitted to the ICU and
    24% required IMV2

The 2015-2016 study results are similar to those observed in the
2014-2015 RSV season of the SENTINEL1 study which found that RSV
hospitalizations, ICU admission and IMV are more frequent in preterm
infants at a younger chronologic age.2

Lead study investigator, Evan J. Anderson, MD, Associate Professor of
Pediatrics at Emory University School of Medicine, stated: “SENTINEL1
highlights the physical, emotional and financial burden severe RSV
disease may have on high-risk infants and their caregivers. The data
show the broader impact of the RSV disease burden on US preterm infants
that should be considered.”

Emotional Burden High Among Parents and Caregivers

In addition to the important insights regarding increased rates of ICU
admission and IMV from SENTINEL1, a separate analysis of the data
highlights the extended impact RSVH has on parents and caregivers, an
area where there are currently few contemporary data.

Self-reported responses were collected from parents and caregivers
participating in the SENTINEL1 study and found that RSVH have a
considerable impact on caregivers and their infants, including continued
medical concerns, emotional burden and financial implications, that
continued through one month post-discharge.4

  • For the 212 infants whose parents/guardians enrolled them in the study
    to provide detailed data regarding their experience, 86% of caregivers
    provided responses at discharge, with the highest percentage reporting
    impact on emotions (54%), routine disruptions (36%), family
    relationships (31%) and financial burdens (30%) at discharge4
  • At one month after discharge, caregivers expressed the highest impact
    on emotions (33%), routine disruptions (20%) and medical concerns (13%)4

The growing body of evidence from SENTINEL1 and other studies will help
the medical community better understand the current impact of severe RSV
disease on US preterm infants and their families.

Details around these data presentations can be accessed below or on the
IDWeek 2016 website here.

  • SENTINEL1: An Ongoing Multicenter Observational Study of Respiratory
    Syncytial Virus Hospitalizations Among US Infants Born at 29–35 Weeks’
    Gestational Age Not Receiving Immunoprophylaxis in 2014–2016 (Clinical
    Infectious Diseases: Respiratory Infections Session, Poster Number
    1279, Friday, October 28, 12:30-2:00 PM ET)
  • “Caregiver Impact of Respiratory Syncytial Virus Hospitalizations
    among US Preterm Infants 29–35 Weeks’ Gestational Age” (Clinical
    Infectious Diseases: Respiratory Infections Session, Poster Number
    1287, Friday, October 28, 12:30-2:00 PM ET)

NOTES TO EDITORS

About SENTINEL1

SENTINEL1 is an ongoing retrospective and prospective study aimed to
characterize RSV-confirmed hospitalizations among US preterm infants
born at 29-35 weeks gestation who did not receive immunoprophylaxis
within 35 days before the onset of RSV disease symptoms during the
2014-2015 and 2015-2016 RSV season.1 The eligibility criteria
for SENTINEL1 include preterm infants 29-35 wGA who were <12 months of
age at the time of their RSVH admission and had been hospitalized for
≥24 hours due to laboratory-confirmed RSV disease.1 SENTINEL1
evaluated gestational age, chronologic age, hospital length of stay
(LOS), ICU admission, ICU LOS, need for IMV, and survival.1

About IDWeek

IDWeek 2016™ is an annual meeting of the Infectious Diseases Society of
America (IDSA), the Society for Healthcare Epidemiology of America
(SHEA), the HIV Medicine Association (HIVMA) and the Pediatric
Infectious Diseases Society (PIDS). With the theme “Advancing Science,
Improving Care,” IDWeek features the latest science and bench-to-bedside
approaches in prevention, diagnosis, treatment, and epidemiology of
infectious diseases, including HIV, across the lifespan. IDWeek 2016
takes place October 26-30 at the Ernest N. Morial Convention Center in
New Orleans. For more information, visit www.idweek.org.

About RSV

RSV is a contagious, seasonal respiratory virus that nearly 100% of
children will contract, at varying levels of severity, by the age of two
and most will recover from within 1-2 weeks.5,6,7 In certain
high-risk babies, however, RSV can lead to a serious lung infection and
hospitalization.8,9 Preterm infants are at increased risk of
developing severe RSV disease because their lung volume is significantly
less than that of full-term infants, and their airways are smaller and
narrower than those of a baby born at term.10

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in three
main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information, please visit www.astrazeneca-us.com
and follow us on Twitter @AstraZenecaUS.

References

  1. Anderson E, Krilov L, DeVincenzo J, et al. SENTINEL1: An observational
    study of respiratory syncytial virus hospitalizations among US infants
    born at 29 to 35 weeks’ gestational age not receiving
    immunoprophylaxis. Am J Perinatol. In press.
  2. Anderson EJ, DeVincenzo JP, Checchia PA, et al. SENTINEL1: An Ongoing
    Multicenter Observational Study of Respiratory Syncytial Virus
    Hospitalizations Among US Infants Born at 29-35 Weeks’ Gestational Age
    Not Receiving Immunoprophylaxis in 2014-2016. Poster Number 1279.
    Poster presented at IDWeek 2016 Meeting, October 26-30, 2016.
  3. Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric
    hospitalizations, 1997 to 1999. Pediatr Infect Dis J. 2002;
    21:629-632.
  4. Pokrzywinski RM, Swett LL, Yi J, et al. Caregiver Impact of
    Respiratory Syncytial Virus Hospitalizations among US Preterm Infants
    29-35 Weeks’ Gestational Age. Poster Number 1287. Poster presented at
    IDWeek 2016 Meeting, October 26-30, 2016.
  5. Centers for Disease Control and Prevention. Infection and Incidence. http://www.cdc.gov/rsv/about/infection.html.
    Accessed October 14, 2016.
  6. Glezen WP, Taber LJ, Frank AL, Kasel JA. Risk of Primary Infection and
    Reinfection with Respiratory Syncytial Virus. Am J Dis Child.
    1986; 140:543-546.
  7. Hall CB, Weinberg GA, Iwane MK, et al. The Burden of Respiratory
    Syncytial Virus Infection in Young Children. N Engl J Med.
    2009; 360:588-598.
  8. Boyce TG, et al. Rates of hospitalizations for respiratory syncytial
    virus infection among children in Medicaid. J Pediatr. 2000;
    137:865-70.
  9. Centers for Disease Control and Prevention. Preterm Birth. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm.
    Accessed October 14, 2016.
  10. Langston C, Kida K, Reed M, Thurlbeck WM. Human lung growth in late
    gestation and in the neonate. Am Rev Respir Dis. 1984;
    129:607-613.

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Contacts

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or
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Bozarth +1 302-885-2677