scholarly journals 1406. Comparison of Clinical Presentations and Burden of Respiratory Syncytial Virus in Infants Across Three Distinct Healthcare Settings

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S711-S711
Author(s):  
Danielle A Rankin ◽  
Zaid Haddadin ◽  
loren lipworth ◽  
Jon Fryzek ◽  
Mina Suh ◽  
...  

Abstract Background Respiratory syncytial virus (RSV) accounts for the majority of lower respiratory tract illnesses in hospitalized infants. In the U.S., RSV hospitalizations are well characterized; yet, emergency department (ED) and outpatient (OP) visits are underrecognized. We evaluated the burden of RSV across three distinct healthcare settings during one respiratory season. Methods From 12/16/19-4/30/20, we conducted a prospective RSV surveillance study among Davidson County, TN infants under one year who presented to an inpatient (IP), ED, or one of four OP clinics with either fever or any upper respiratory (i.e., cough, earache, nasal congestion, rhinorrhea, sore throat) and/or lower respiratory [i.e., wheezing, crackles, rales, diminished breath sounds, shortness of breath (SOB)] symptoms. Demographic and illness history were collected during parental/guardian interviews, followed by medical chart abstraction. Nasal swabs were collected and tested for RSV using Luminex® NxTAG RPP. Due to the COVID-19 pandemic, on 3/16/20 enrollment at three of the four OP clinics ceased. Results A total of 627 infants were screened, of whom 473 (75%) were confirmed eligible, 364 (77%) enrolled, 361 (99%) were tested for RSV of which 101 (28%) were RSV+ (IP=37, ED=18, OP=46) (Figure 1). Compared to RSV-negative subjects, RSV+ subjects were younger (6.6 vs. 4.9 months, p< 0.001), 56% were male and 48% white. By setting, infants in the OP setting were older than those seen in the IP and ED [(p=0.002), Figure 2]. Compared to infants in the OP setting, hospitalized infants were more likely to present with SOB and rhonchi/rales, but less likely to have only upper respiratory symptoms (Figure 3) and be African American (p=0.046). Infants in the IP setting had a higher proportion of clinical RSV diagnostic testing (73%) compared to the ED (39%) and OP (28%) settings (p< 0.001). Figure 1. Davidson County Infants with RSV by MMWR Week and Healthcare Setting (n=101) Figure 2. Cumulative Enrollment of Davidson County Infants with RSV by Age in Months and Healthcare Setting (n=101) Figure 3. Proportion of Davidson County Infants with RSV Showing each Clinical Symptom, by Healthcare Setting Conclusion Two-thirds of RSV+ infants sought care from either an OP or ED setting, with nearly all hospitalized infants presenting with both upper and lower respiratory symptoms. The underutilization of diagnostic testing in the OP settings may underestimate the true burden of RSV. Future studies are essential to document the true prevalence of RSV in order to assess the need and impact of new interventions (e.g., immunizations, antivirals). Disclosures Danielle A. Rankin, MPH, CIC, Sanofi Pasteur (Grant/Research Support, Research Grant or Support) Zaid Haddadin, MD, CDC (Grant/Research Support, Research Grant or Support)Quidel Corporation (Grant/Research Support, Research Grant or Support)sanofi pasteur (Grant/Research Support, Research Grant or Support) Jon Fryzek, PhD, MPH, EpidStrategies (Employee) Mina Suh, MPH, International Health, EpidStrategies (Employee) Donald S. Shepard, PhD, Sanofi Pasteur (Grant/Research Support) Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S430-S431
Author(s):  
Zaid Haddadin ◽  
Danielle A Rankin ◽  
Ahmad Yanis ◽  
Yanal Shawareb ◽  
Olla Hamdan ◽  
...  

Abstract Background Respiratory syncytial virus (RSV) is the leading cause of acute respiratory infections (ARI) hospitalizations in young children and is associated with increased severity compared to other viruses. The aim of this study was to evaluate the utilization of a rapid RSV diagnostic test and clinical characteristics and disease severity of children who were hospitalized during one respiratory season in Amman, Jordan. Methods Children less than two years hospitalized with fever and/or respiratory symptoms were recruited at Al-Bashir Government Hospital from January 8, 2020, to March 17, 2020. Nasal swabs were collected and tested by Sofia-2 RSV Fluorescent Immunoassay. Demographic information and clinical history were obtained through parental interviews. A validated severity score was used to assess disease severity, and the treating physician prospectively collected the necessary information to calculate the score at admission. Disease severity was categorized based on the total score into 0-5 mild, 6-9 moderate, and ≥ 10 severe. Molecular testing and medical chart reviews are still in process. Results A total of 532 subjects were enrolled, and nasal swabs were collected and tested from 458 (86%) of enrollees. The most common admission diagnoses were pneumonia (25%), bronchopneumonia (21%), bronchiolitis (19%) and sepsis (17%). Demographic and clinical characteristics are included in Table 1. Overall, 276 (60%) subjects were RSV-positive. The most common admission diagnoses were pneumonia (33%), sepsis (25%), bronchiolitis (24%) and bronchopneumonia (24%). Compared to RSV-negative children, RSV-positive children were younger (Table 1), and more likely to present with cough, nasal congestion, and appetite loss (Figure 1). There were no differences in severity score or direct intensive care unit admission between the two groups (Table 1). Figure 1. Symptom Distribution in RSV-Positive and RSV-Negative Subjects Conclusion Nearly 2/3 of children enrolled were RSV-positive via rapid diagnostic testing. The majority of RSV-ARI admissions were classified as mild. Further analysis of other clinical parameters, including oxygen use, intravenous fluids administration and length of stay, and molecular testing are needed to support these findings and further evaluate the utility of rapid diagnostic testing. Disclosures Zaid Haddadin, MD, CDC (Grant/Research Support, Research Grant or Support)Quidel Corporation (Grant/Research Support, Research Grant or Support)sanofi pasteur (Grant/Research Support, Research Grant or Support) Danielle A. Rankin, MPH, CIC, Sanofi Pasteur (Grant/Research Support, Research Grant or Support) Ahmad Yanis, MD, Quidel Corporation (Grant/Research Support) Yanal Shawareb, MD, Quidel (Grant/Research Support)Quidel (Grant/Research Support, Research Grant or Support, Sanofi) Olla Hamdan, BS, Quidel (Grant/Research Support, Research Grant or Support) Malek Saada, MD, Quidel Corporation (Grant/Research Support, Research Grant or Support) Sara Hilal, MD, Quidel Corporation (Grant/Research Support, Research Grant or Support) Ahmad Alhajajra, MD, Quidel Corporation (Grant/Research Support, Research Grant or Support) Basima Marar, MD, Quidel Corporation (Grant/Research Support, Research Grant or Support) Najwa Khuri-Bulos, MD, Quidel Corporation (Grant/Research Support, Research Grant or Support)


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S248-S249
Author(s):  
Leigh Howard ◽  
Kathryn Garguilo ◽  
Jessica Gillon ◽  
Steven Webber ◽  
Natasha B Halasa ◽  
...  

Abstract Background Little is known regarding the full spectrum of illness among children with SARS-CoV-2 infection across integrated healthcare settings, as many published pediatric cohorts focus on hospitalized patients with SARS-CoV-2 infection. Methods Active surveillance was performed for SARS-CoV-2 detections among symptomatic and asymptomatic children and adolescents ≤18 years of age in a quaternary care academic hospital laboratory in the Southeastern U.S. For symptomatic patients with a positive respiratory specimen for SARS-CoV-2 by polymerase chain reaction (PCR), and for neonates born to SARS-CoV-2-positive mothers, we performed phone follow-up and medical record review at days 2, 7, and 30 after diagnosis. Testing was initiated 3/12/20 for symptomatic patients and 5/4/20 for screening asymptomatic patients. Results By 6/14/20, SARS-CoV-2 tests were positive in 193/5306 (3.6%) specimens from unique patients ≤18 (Table 1), compared to 2653/36503 (7.2%) specimens in patients >18 years. Specimens from 181/2638 (6.8%) symptomatic and 12/2768 (0.4%) asymptomatic children were positive. Nine infants born to SARS-CoV-2 infected mothers had negative PCR tests at birth; 1 infant subsequently acquired SARS-CoV-2 infection at 5 weeks of age. Sociodemographic and clinical data for 181 SARS-CoV-2-positive symptomatic children are displayed in Table 2 and Figure 1. The most common symptoms were cough (59%), fever (50%), and rhinorrhea (39%). Nine/181 symptomatic patients (5%) were hospitalized, primarily for respiratory symptoms. Symptom resolution occurred by follow-up day 2 in 82/178 (46%) and day 7 in 128/164 (78%) patients with complete assessments to date. 131/181 (72%) of children had known SARS-CoV-2 positive contacts. We observed no cases of multisystem inflammatory syndrome in children. Conclusion In our community, pediatric SARS-CoV-2 prevalence was low, but was much higher among symptomatic than asymptomatic children. Symptoms were mild, and the duration of symptoms brief, in the majority of these patients captured within an integrated ambulatory and hospital-based healthcare system, capturing the full spectrum of the disease profile in this age group. Disclosures Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support)


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S491-S492
Author(s):  
Zaid Haddadin ◽  
Danielle A Rankin ◽  
loren lipworth ◽  
Jon Fryzek ◽  
Mina Suh ◽  
...  

Abstract Background Acute respiratory infections (ARI) are a major cause of morbidity and mortality in young children, with viral pathogens being the most common etiologies. However, due to limited and inconsistent clinical diagnostic viral testing in the outpatient (OP) setting compared to the inpatient (IP) setting, the actual burden and distribution of viral pathogens across these clinical settings remain largely underreported. We aimed to evaluate the frequency of common respiratory viruses in medically attended ARI in infants. Methods We conducted a prospective viral surveillance study in Davidson County, TN. Eligible infants under one year presenting with fever and/or respiratory symptoms were enrolled from OP, emergency department (ED), or IP settings. Nasal swabs were collected and tested for common viral pathogens using Luminex® NxTAG Respiratory Pathogen Panel and for SARS-CoV-2 using Luminex® NxTAG CoV extended panel. Results From 12/16/2019 to 4/30/2020, 364 infants were enrolled, and 361 (99%) had nasal swabs collected and tested. Of those, 295 (82%) had at least one virus detected; rhinovirus/enterovirus (RV/EV) [124 (42%)], respiratory syncytial virus (RSV) [101 (32%)], and influenza (flu) [44 (15%)] were the three most common pathogens detected. No samples tested positive for SARS-CoV-2. Overall, the mean age was 6.1 months, 50% were male, 45% White and 27% Hispanic. Figure 1 shows the total number of PCR viral testing results by month. RSV was the most frequent virus detected in the IP (63%) and ED (37%) settings, while RV/EV was the most common in the OP setting (Figure 2). Figure 3 displays viral seasonality by clinical setting, showing an abrupt decrease in virus-positive cases following the implementation of a stay-at-home order on March 23, 2020 in Nashville, TN. Distribution of Respiratory Viruses in Different Settings Distribution of Respiratory Viruses in Different Settings by Season Conclusion Most medical encounters in infants are due to viral pathogens, with RSV, RV/EV, and flu being the most common. However, distributions differed by clinical setting, with RSV being the most frequently detected in the IP and ED settings, and second to RV/EV in the OP setting. Continued active viral ARI surveillance in various clinical settings is warranted. Preventative measures such as vaccines and infection control measures deserve study to reduce viral ARI burden. Disclosures Zaid Haddadin, MD, CDC (Grant/Research Support, Research Grant or Support)Quidel Corporation (Grant/Research Support, Research Grant or Support)sanofi pasteur (Grant/Research Support, Research Grant or Support) Danielle A. Rankin, MPH, CIC, Sanofi Pasteur (Grant/Research Support, Research Grant or Support) Jon Fryzek, PhD, MPH, EpidStrategies (Employee) Mina Suh, MPH, International Health, EpidStrategies (Employee) Donald S. Shepard, PhD, Sanofi Pasteur (Grant/Research Support) Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support)


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S756-S757
Author(s):  
Zaid Haddadin ◽  
Danielle A Rankin ◽  
loren lipworth ◽  
Jon Fryzek ◽  
Mina Suh ◽  
...  

Abstract Background Viral acute respiratory infections (ARI) continues to be a significant cause of healthcare visits in young children. We evaluated the clinical presentation and disease severity of common respiratory viruses associated with medically attended ARI in infants. Methods We conducted a prospective viral surveillance study in Davidson County, TN. Infants under one year with fever and/or respiratory symptoms were enrolled from the outpatient (OP), emergency department (ED), or inpatient (IP) settings from 12/16/2019 through 4/30/2020. Nasal swabs were collected and tested for common viral pathogens using Luminex® NxTAG Respiratory Pathogen Panel. Demographic and clinical characteristics were collected through parent/guardian interviews and medical chart abstractions. Results In total, 364 participants were enrolled, and 361 (99%) had nasal swabs collected and tested. Overall, mean age was 6±3.3 months, 50% were female, 45% White, and 27% Hispanic. Of the 295 (82%) virus-positive specimens; the three most common viruses were rhinovirus/enterovirus (RV/EV), respiratory syncytial virus (RSV), and influenza (flu) [124, 101, and 44, respectively]. Compared to virus-negative infants, virus-positive infants were more likely to have more severe ARI symptoms and to be admitted to the intensive care unit (Table 1). Compared to other virus-positive infants: RV/EV-positive infants were more likely to be White, attend daycare, but less likely to present with respiratory distress, or require oxygen or admission; flu-positive infants were older and more likely to have systemic symptoms rather than ARI symptoms, and RSV-positive infants were more likely to present with respiratory distress, receive oxygen and be hospitalized (Table 1). Table 1. Demographic and Clinical Characteristics of Study Subjects Conclusion The majority of ARI in infants are due to respiratory viruses, with RSV, RV/EV, and flu accounting for over three-quarters of these viruses. The clinical presentations and disease severity differed across the clinical settings and the three main viruses, with RSV being most severe. To decrease the burden of medically attended viral ARI, preventive measures (i.e., developing new vaccines and antivirals), refining current vaccination strategies, and infection control measures are needed. Disclosures Zaid Haddadin, MD, CDC (Grant/Research Support, Research Grant or Support)Quidel Corporation (Grant/Research Support, Research Grant or Support)sanofi pasteur (Grant/Research Support, Research Grant or Support) Danielle A. Rankin, MPH, CIC, Sanofi Pasteur (Grant/Research Support, Research Grant or Support) Jon Fryzek, PhD, MPH, EpidStrategies (Employee) Mina Suh, MPH, International Health, EpidStrategies (Employee) Donald S. Shepard, PhD, Sanofi Pasteur (Grant/Research Support) Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support)


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S258-S259
Author(s):  
Shikha Garg ◽  
Charisse Nitura Cummings ◽  
Alissa O’Halloran ◽  
Pam Daily Kirley ◽  
Rachel Herlihy ◽  
...  

Abstract Background Influenza is most commonly associated with respiratory complications; however, nonrespiratory complications occur frequently among patients hospitalized with influenza. We used data from the Influenza Hospitalization Surveillance Network (FluSurv-NET) to describe complications recorded on discharge summaries of patients hospitalized with influenza. Methods We included children (0–17 years) and adults (≥18 years), who resided within a FluSurv-NET catchment area and were hospitalized with laboratory-confirmed influenza during 2016–2017. We abstracted data on underlying conditions and discharge diagnoses from medical charts. We calculated the frequency of respiratory and nonrespiratory complications in all age groups and used univariate and multivariable logistic regression to examine factors associated with select complications among adults. Results Among 17,489 patients, the most common respiratory complications were pneumonia (26%) and acute respiratory failure (23%) and the most common nonrespiratory complications were sepsis (16%) and acute renal failure (ARF) (12%). Complications varied by age group (figure). Pneumonia was the most common respiratory complication in all age groups except 0–4 years; among children aged 0–4 years bronchiolitis was most common (104/712; 15%). Among 97 children aged 0–4 years with bronchiolitis who underwent testing for respiratory syncytial virus (RSV), 37% had RSV. The most common nonrespiratory complication was seizures in children aged 0–17 years (17% had a history of prior seizures) and sepsis in adults. Among adults (n = 16,057), factors most strongly associated with ARF included chronic renal disease (adjusted odds ratio (AOR) 2.5; 95% confidence interval (95% CI) 2.2–2.8), male sex (AOR 1.5 95% CI 1.4–1.7) and age ≥65 years (AOR 1.4 95% CI 1.2–1.7); the factor most strongly associated with sepsis was chronic neuromuscular disease (AOR 1.5 95% CI 1.3–1.8). Conclusion Influenza hospitalizations are associated with a broad spectrum of complications including pneumonia, respiratory failure, sepsis, ARF and seizures. During the influenza season, astute clinicians should keep influenza in the differential diagnosis for patients with a wide range of presentations. :Disclosures. H. K. Talbot, sanofi pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none. E. J. Anderson, NovaVax: Grant Investigator, Research grant. Pfizer: Grant Investigator, Research grant. AbbVie: Consultant, Consulting fee. MedImmune: Investigator, Research support. PaxVax: Investigator, Research support. Micron: Investigator, Research support.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S268-S268 ◽  
Author(s):  
Lindsay Kim ◽  
Bryanna Cikesh ◽  
Pam Daily Kirley ◽  
Evan J Anderson ◽  
Seth Eckel ◽  
...  

Abstract Background Respiratory syncytial virus (RSV) vaccines are in clinical development for older adults. We described RSV infections among adults requiring hospitalization and risk factors for severe outcomes using a population-based platform, the Influenza Hospitalization Surveillance Network (FluSurv-NET). Methods Surveillance occurred October 1–April 30 (2014–2017) at sites located in seven states (California, Georgia, Michigan, Minnesota, New York, Oregon, and Tennessee) covering an annual catchment population of up to 13 million adults ≥18 years. Laboratory-confirmed RSV cases were identified using hospital and state public health laboratories, hospital infection preventionists, and/or reportable condition databases. Medical charts were reviewed for demographic and clinical data. International Classification of Diseases (ICD) discharge codes were abstracted. Odds ratios (Oregon) and 95% confidence intervals (CIs) were determined to assess risk factors for ICU hospitalization and deaths. Results A total of 2,326 hospitalized RSV cases were identified. Over half were ≥65 years (62%, n = 1,438/2,326), female (59%, n = 1,362/2,326), white (70%, n = 1,301/1,855), and had ≥3 underlying medical conditions (52%, n = 1,204/2,326). 20% (n = 398/2,000) were hospitalized in the ICU (median length of stay, 3 days; interquartile range, 1–6 days), and 5% (n = 96/2,001) died in the hospital. Congestive heart failure (CHF; OR: 1.4, 95% CI: 1.1–1.8) and chronic obstructive pulmonary disease (COPD; OR: 1.3, 95% CI: 1.1–1.7) were associated with ICU admission, while age ≥80 years (OR: 4.1, 95% CI: 1.8–12.1) and CHF (OR: 2.4, 95% CI: 1.6–3.6) were associated with in-hospital deaths. RSV-specific ICD codes were listed in the first 9 positions in only 44% (879/1,987) of cases. Conclusion To our knowledge, this is the largest US case series of RSV-infected hospitalized adults. Most cases were ≥65 years and had multiple underlying medical conditions. Older age, CHF, and COPD were associated with the most severe outcomes. Few cases had RSV-specific ICD codes, suggesting that administrative data underestimate adult RSV-related hospitalizations. Continued surveillance is needed to understand the epidemiology of RSV among adults as vaccine products move toward licensure. Disclosures E. J. Anderson, NovaVax: Grant Investigator, Research grant. Pfizer: Grant Investigator, Research grant. AbbVie: Consultant, Consulting fee. MedImmune: Investigator, Research support. PaxVax: Investigator, Research support. Micron: Investigator, Research support. H. K. Talbot, sanofi pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S392-S392
Author(s):  
Steven S Spires ◽  
Rebecca Rayburn-Reeves ◽  
Elizabeth Dodds Ashley ◽  
Jenna Clark ◽  
Avani P Desai ◽  
...  

Abstract Background The COVID-19 pandemic has brought vaccination to the forefront of discourse on public health. The rapid speed of COVID-19 vaccine development, utilization of novel technology, and an atmosphere of politicized misinformation have created a perfect storm for vaccine hesitancy. As early adopters of vaccination, HCWs set an example for the general population; as trusted sources of medical information, they educate and inform. However, comparatively little work has investigated HCWs' attitudes toward vaccination and how those attitudes drive their recommendation behavior. Methods We surveyed hospital employees about their personal reasons for hesitancy and beliefs about patient hesitancies and randomly assigned them to see one of three messages aimed at increasing vaccine confidence. Message themes included an appeal to return to normal life (Normalcy), a risk comparison between vaccinating or not (SDT), and an explanation of the speed of safe and effective vaccine development (Process). Results Of the 674 NC hospital employees who completed our survey in February 2021, 98% had been offered the COVID-19 vaccine, and 80% had already accepted. For the 20% who had not received the vaccine, the top reasons for hesitancy involved the speed of development and testing, and concerns of vaccine safety and effectiveness. We also found differences in susceptibility to misinformation and vaccine hesitancy across political affiliation, which was higher in Republicans compared to Democrats. HCWs were generally very comfortable recommending the COVID-19 vaccine to patients and supported the idea of sharing the message they read. Although the risk comparison message was most trusted personally, the process message was rated as both the most helpful to patients and the most likely to be shared with them (see Figure 1). This suggests that what is most appealing on a personal level is not necessarily what a HCW would recommend to their patients. Rating of personal opinions of the passages. On a scale from 1 to 7 with 1 = Strongly Disagree and 7 = Strongly Agree. This chart shows the average message ratings across the board when answering whether they thought the passages were understandable, helpful, correct, believable, and trustworthy. (Error bars are 95% CI) There was no significant difference across the messages. The Process message is seen as most helpful and is most likely to be shared with patient than the other messages On left, the average answer on a scale from 1 to 5 for “Do you think the passage you just read would help your patients feel more comfortable about getting the vaccine?” and on right, the average answer for “Would you share this passage with your patients?” Conclusion HCWs' high uptake and minimal hesitancy in recommending the COVID-19 vaccine is encouraging and merits further exploration for how to increase confidence in HCW who are hesitant to discuss and recommend vaccines to patients, as several highlighted the importance of respecting patient autonomy. Disclosures Rebecca Rayburn-Reeves, PhD, Centene Corporation (Grant/Research Support, Research Grant or Support) Jenna Clark, PhD, Centene Corporation (Grant/Research Support, Research Grant or Support) Jan Lindemans, PhD, Centene Corportation (Grant/Research Support, Scientific Research Study Investigator)


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S756-S756
Author(s):  
Jason Gantenberg ◽  
Nicole Zimmerman ◽  
Andrew R Zullo ◽  
Brendan Limone ◽  
Clarisse Demont ◽  
...  

Abstract Background RSV-associated lower respiratory tract infection (LRTI) is the leading cause of infant hospitalization. Most studies of RSV have focused on infants with underlying comorbidities, including prematurity. The purpose of this analysis is to describe the burden of RSV LRTI across all medical settings and in all infants experiencing their first RSV season. Methods Using de-identified claims data from two commercial (MarketScan Commercial, MSC; Optum Clinformatics, OC) and one public (MarketScan Medicaid, MSM) insurance database, we estimated the prevalence of MA RSV LRTI among infants born between April 1, 2016 and June 30, 2019 in their first RSV season. Estimates were made by gestational age, presence/absence of comorbidities, and setting (inpatient, emergency department and outpatient). Due to limited laboratory testing, we defined MA RSV LRTI using two sets of ICD-10-CM diagnosis codes: a specific definition (identifying RSV explicitly) and a sensitive definition that included unspecified bronchiolitis. The first specific diagnosis triggered a search for another MA RSV LRTI diagnosis (either specific or sensitive) within the next 7 days. In the sensitive analysis, the first diagnosis was allowed to meet the sensitive definition. Setting was recorded as the highest level of care attached to a MA RSV LRTI diagnosis within this 7-day period. Results Using the specific (sensitive) definitions, 4.2% (12.2%), 6.8% (16.8%), and 2.7% (7.2%) of newborns had an MA RSV LRTI diagnosis during their first respiratory season across the MSC, MSM, and OC datasets (Table 1). Term infants without comorbidities accounted for 77% (83%), 79% (86%), and 80 (81%) of all MA RSV LRTI, and 21% (10%), 19% (10%), and 21% (10%) of all infants with MA RSV LRTI had an inpatient hospital stay (Table 2). Term infants without comorbidities accounted for 69% (68%), 67% (79%), and 73% (73%) of all MA RSV LRTI inpatients (Table 2). Conclusion In commercial and public claims data, during their first RSV season, term infants without comorbidities accounted for a sizable majority of inpatient, emergency room, and outpatient encounters for RSV LRTI in the US. To address the burden of RSV LRTI, future RSV prevention efforts should target all infants. Funding Sanofi Pasteur, AstraZeneca Disclosures Jason Gantenberg, MPH, Sanofi Pasteur (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support) Nicole Zimmerman, MS, IBM Watson Health (Employee, Nicole Zimmerman is an employee of IBM, which was compensated by Sanofi to complete this work.)Sanofi (Other Financial or Material Support, Nicole Zimmerman is an employee of IBM, which was compensated by Sanofi to complete this work.) Andrew R. Zullo, PharmD, PhD, ScM, Sanofi Pasteur (Grant/Research Support, Research Grant or Support) Brendan Limone, PharmD, PharmD, Sanofi Pasteur (Other Financial or Material Support, IBM was contracted by Sanofi to perform analysis) Clarisse Demont, n/a, Sanofi Pasteur (Employee, Shareholder) Sandra S. Chaves, MD, MSc, Sanofi Pasteur (Employee) William V. La Via, MD, AstraZeneca (Shareholder)Sanofi Pasteur (Employee) Christopher Nelson, PhD, Epidemiology, Sanofi Pasteur (Employee) Christopher Rizzo, MD, Sanofi (Employee) David A. Savitz, PhD, Sanofi Pasteur (Grant/Research Support) Robertus Van Aalst, MSc, Sanofi Pasteur (Employee, Shareholder)


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S688-S688
Author(s):  
Cristina Tomatis Souverbielle ◽  
Fang Ye ◽  
Sara Mertz ◽  
Mark E Peeples ◽  
Octavio Ramilo ◽  
...  

Abstract Background The burden associated with RSV infection is substantial. Although RSV initially infects the upper respiratory tract, there is limited information of the mucosal concentrations of antibodies (Abs) directed to RSV specific proteins and whether patient’s age and disease severity influence production of mucosal Abs. Methods From 2017 to2019 we enrolled previously healthy children < 2 years of age hospitalized with RSV infection and obtained acute and convalescent (day; D30) nasopharyngeal (NP) samples to measure preF and postF specific IgG and IgA Abs by ELISA. Demographic and clinical data were collected and analyzed according to Abs responses. Results We enrolled 77 children (median [IQR] age: 2.8 [1.5-5.2] months; 49 % females) within the first 24 hours of hospitalization. Of those 25 (33%) patients required PICU care. A significant increase in convalescent IgG preF Abs titers was detected in 62 (81%) children, while IgA preF titers significantly increased in all but one child on D30. The magnitude of the increase was 56-fold higher for preF IgA versus preF IgG (p< 0.0001). PostF IgG and IgA titers were also increased on D30 but at significant lower levels. Infants < 3 months of age compared with those >3-24 months had significantly higher baseline preF and postF IgG Abs titers (p < 0.001) but not IgA antibodies. D30 preF and post F IgG titers were higher in children > 6 months of age (p < 0.0001) but only preF titers fold change significantly correlated with age (r=0.4, p< 0.0001). These correlations were not identified with IgA preF antibodies. There were no statistical differences in antibody titers at baseline and on D30 according to breastfeeding, and disease severity as defined by the need for PICU care. Conclusion Children hospitalized with RSV infection demonstrated significantly increased titers of mucosal preF and post F IgG and IgA specific Abs in convalescent samples. Baseline IgG Abs where higher in younger infants, which likely reflects maternally acquired antibodies. Age significantly correlated with Abs production, suggesting a more robust immune response in older children. Disclosures Mark E. Peeples, PhD, Janssen (Research Grant or Support)Pfizer (Research Grant or Support) Octavio Ramilo, MD, Adagio (Consultant)Bill & Melinda Gates Foundation (Grant/Research Support)Janssen (Grant/Research Support)Lilly (Consultant)Merck (Consultant, Grant/Research Support)NIH (Grant/Research Support)Pfizer (Consultant)SANOFI (Board Member) Asuncion Mejias, MD, PhD, MsCS, Janssen (Grant/Research Support, Advisor or Review Panel member)Merck (Grant/Research Support, Advisor or Review Panel member)Roche (Advisor or Review Panel member)Sanofi (Advisor or Review Panel member)


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S524-S525
Author(s):  
Albert Liu ◽  
Albert Liu ◽  
Robert Grant ◽  
Raphael J Landovitz ◽  
Raphael J Landovitz ◽  
...  

Abstract Background The use of daily F/TDF for HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV acquisition. Dried blood spot (DBS) tenofovir-diphosphate (TFV-DP) levels reflect TDF use over the past 6-8 weeks, providing an objective measure of adherence in people taking PrEP. Methods In a pooled analysis of 19 PrEP demonstration projects and clinical studies, 6,613 participants had at least one TFV-DP measurement in DBS and followed for at least 48 weeks and up to 96 weeks. We used a piecewise linear mixed-effects model to plot the least-square means with corresponding 95% confidence intervals (CI) of TFV-DP for adherence over time, and Poisson regressions to calculate HIV incidence rates (IR) by level of weighted average of TFV-DP. Results Of 6,613 participants, median age was 30 years (interquartile range 24−38), 5,449 (82%) were cisgender men, 806 (12%) were cisgender women, and 349 (5%) were transgender (316 transgender women, 2 transgender men, 31 unspecified). Adherence based on TFV-DP in DBS was consistently higher among participants who did not acquire HIV compared to those who did (Figure). Among all participants, 21%, 14%, 36%, and 29% has DBS consistent with taking < 2, 2−3, 4−6, and ≥7 tablets of F/TDF PrEP per week (Table). Sixty-nine participants acquired HIV, with a median PrEP exposure of 0.82 years and an overall HIV IR (95% CI) of 1.16 (0.92, 1.47) per 100 person years. There was a strong association between adherence and HIV incidence [among individuals who took < 2, 2−3, 4−6, and ≥7 tablets/week, the HIV IRs (95% CI) were 5.20 (4.03, 6.71), 0.38 (0.12, 1.18), 0.28 (0.12, 0.61), and 0.06 (0.01, 0.39), respectively. Overall IR (95% CI) of HIV infection among cisgender men was 1.25 (0.98, 1.60) per 100 patient-years. Four cisgender women and 2 transgender participants acquired HIV, corresponding to IRs (95% CI) of 0.71 (0.27, 1.90) and 0.63 (0.16, 2.53). Adherence by TFV-DP in DBS for F/TDF users who acquired HIV compared to those who did not. Note: ‘x’ on the Figure represents visit week when a new HIV infection was detected. HIV incidence rates (95% confidence intervals) by adherence to PrEP measured by level of TFV-DP in DBS up to 96 weeks after PrEP Initiation Conclusion This diverse, multi-national pooled analysis of F/TDF PrEP use provides the largest assessment to date of the adherence-HIV incidence relationship in people taking F/TDF for PrEP. The results suggest a high background HIV incidence in the pooled cohort and high efficacy in those adherent to PrEP. These findings support ongoing efforts to increase PrEP use among people who would benefit. Disclosures Albert Liu, MD, MPH, Gilead Sciences (Individual(s) Involved: Self): Gilead has donated study drug for studies I have led., Grant/Research Support, Other Financial or Material Support, Research Grant or Support; IAS-USA (Individual(s) Involved: Self): Honorarium for manuscript writing, Other Financial or Material Support; Viiv Healthcare (Individual(s) Involved: Self): Grant/Research Support, Research Grant or Support Raphael J. Landovitz, MD, MSc, Gilead Sciences (Individual(s) Involved: Self): Consultant; Janssen (Individual(s) Involved: Self): Consultant; Merck Inc (Individual(s) Involved: Self): Consultant; Roche (Individual(s) Involved: Self): Consultant Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) David Magnuson, PharmD, Gilead Sciences Inc (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Li Tao, MD, PhD, Gilead Sciences Inc (Employee, Shareholder)


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