AstraZeneca Presents Respiratory Syncytial Virus (RSV) Study Results at IDWeek 2015

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In collaboration with physicians at 43 US hospitals, AstraZeneca today presented results from an ongoing observational study, SENTINEL1, at the IDWeek 2015 annual scientific meeting in San Diego, California. SENTINEL1 was designed to characterize RSV-confirmed hospitalizations among US preterm infants born at 29-35 weeks gestation who did not receive immunoprophylaxis during the 2014-2015 RSV season.1 In July 2014, new guidance was published that recommended against the use of immunoprophylaxis for respiratory syncytial virus (RSV) in preterm infants born at 29-35 weeks gestation who do not have chronic lung disease.2 The study results confirmed that among preterm infants 29-35 weeks gestation who did not receive immunoprophylaxis, RSV disease can be severe, often resulting in intensive care unit (ICU) admission and the need for mechanical ventilation (MV).1 "RSV disease is the most common serious infection preterm infants will face in the first months of life," said lead investigator Dr. Leonard Krilov, pediatric infectious disease specialist, Winthrop-University Hospital. "The SENTINEL1 study confirms that preterm infants born at 29-35 weeks gestation commonly have serious complications when hospitalized with RSV disease."1,3,4 The SENTINEL1 study collected data from 43 US hospitals from October 1, 2014, through April 30, 2015. In total, 709 RSV-confirmed hospitalizations were identified among eligible preterm infants born at 29-35 weeks gestation. SENTINEL1 represents the largest study ever conducted in the US of preterm infants hospitalized with laboratory-confirmed severe RSV disease.1 Among these hospitalized infants, 295 (42%) were admitted to the ICU and 140 (20%) required mechanical ventilation. Infants under six months of age accounted for the majority of RSV-confirmed hospitalizations (78%), ICU admissions (87%), and the need for MV (92%).1 Earlier gestational age and younger chronologic age were associated with a higher risk of RSV-confirmed ICU admissions and need for mechanical ventilation.1 Among infants <3 months, 69% of infants 29-32 weeks gestation, 52% of infants 33-34 weeks gestation, and 38% of infants 35 weeks gestation were admitted to the ICU.1 Among infants <3 months, 45% of infants 29-32 weeks gestation, 25% of infants 33-34 weeks gestation, and 19% of infants 35 weeks gestation required MV.1 Adjusting for their prevalence in US births, RSV hospitalizations among infants 29–32 and 33–34 weeks gestation were 2.0-fold (95% CI: 1.6, 2.4) and 1.5-fold (95% CI: 1.2, 1.8) more frequent, respectively, than RSV hospitalizations among infants 35 weeks gestation.1 "The SENTINEL1 data adds significantly to the existing research on the risk of severe RSV disease in US preterm infants," said Dr. Krilov. "It is my hope – and the hope of many concerned clinicians – that physicians carefully consider these data when identifying which of their preterm infants are at high risk for severe RSV disease during the upcoming RSV season."
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