scholarly journals 1393. Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States (US)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S706-S706
Author(s):  
Tanaz Petigara ◽  
Ya-Ting Chen ◽  
Zhiwen Liu ◽  
Michelle Goveia ◽  
David Johnson ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
The United States ◽  
Vaccination Schedule ◽  
Provider Type ◽  
Factors Associated ◽  
Study Investigator ◽  
Region Of Residence ◽  
Birth Dose ◽  
To Receive

Abstract Background The US vaccination schedule includes DTaP, IPV, Hib and HepB doses in the first 6 months of life. A previous analysis found variability in the timing of HepB doses in infants receiving DTaP-IPV/Hib. We explored factors associated with co-administration of DTaP-IPV/Hib and HepB on the same day. Methods This was a retrospective study using the MarketScan® commercial claims and encounters database. Infants born from 1 July 2010 - 30 June 2016, continuously enrolled in an insurance plan for ≥ 13 months and receiving ≥ 3 DTaP-IPV/Hib doses were included. Infants were assessed for HepB claims relative to the first and third DTaP-IPV/Hib doses. Because a HepB birth dose was assumed, the first HepB claim from 29 - 169 days following birth was counted as Dose 2, and the second claim from 170 days - 12 months as Dose 3. Associations between demographic, provider, and insurance characteristics, receipt of other pediatric vaccines, and co-administration of DTaP-IPV/Hib and HepB were analyzed using multivariate logistic regression. Results Among 165,553 infants who received a first DTaP-IPV/Hib dose, 60.7% received HepB Dose 2 on the same day. Among 162,217 infants who received a third DTaP-IPV/Hib dose, 45.1% received HepB Dose 3 on the same day. Infants in the Northeast were less likely (OR=0.38, 95%CI=0.36-0.39), while those in the West were more likely (OR=1.41, 95%CI=1.36-1.46) than infants in the South to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day. Infants vaccinated by pediatricians (OR=0.54, 95%CI=0.53-0.55) were less likely to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day compared to infants vaccinated by family physicians. Infants who received PCV on the same day as the first dose of DTaP-IPV/Hib were more likely to receive HepB Dose 2 (OR=6.96, 95%CI=6.30-7.70) that day. These factors were also associated with co-administration of the third dose of DTaP-IPV/Hib and HepB Dose 3. Conclusion Differences in co-administration of DTaP-IPV/Hib and HepB were associated with region of residence, provider type and co-administration of PCV. The reasons underlying these differences merit exploration. A hexavalent vaccine containing DTaP, IPV, Hib, and HepB could improve timeliness of HepB vaccination, while reducing the number of injections during infancy. Disclosures Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Zhiwen Liu, PhD, Merck & Co., Inc., (Employee) Michelle Goveia, MD, Merck & Co., Inc (Employee, Shareholder) David Johnson, MD, MPH, Sanofi Pasteur (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator)

scholarly journals 1399. Parental Perceptions of the Childhood Vaccination Schedule and Combination Vaccines in the United States (US)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S708-S708
Author(s):  
Tanaz Petigara ◽  
Xinyi Ng ◽  
Ya-Ting Chen ◽  
Jyoti Aggarwal ◽  
Jenna Bhaloo ◽  
...  
Keyword(s):  
Online Survey ◽  
Research Study ◽  
Scientific Research ◽  
The United States ◽  
Vaccination Schedule ◽  
Childhood Vaccination ◽  
Multiple Injections ◽  
Study Investigator ◽  
Vaccine Schedule ◽  
Combination Vaccines

Abstract Background Ten different vaccine series are recommended by the US Advisory Committee on Immunization Practices from birth to 18 months. Combination vaccines can reduce the number of injections and visits required to complete the schedule in a timely manner. There is limited current information on parents’ perception of the vaccine schedule and combination vaccines. Methods An online survey was completed by 100 parents who had at least one child under 2 years, were involved in vaccination decisions, and had accompanied their child to a vaccination appointment. Parents who reported not ever vaccinating their children were excluded. Parents’ perception of, and adherence to, the recommended schedule, communication with providers, and knowledge of combination vaccines were collected. Descriptive analyses were performed. Results Ninety-six percent of parents (mean age=30.7 years; range 19.0-50.0; 91% white) reported their provider as a source of vaccination information, followed by internet searches (63%), family and friends (45%). Most (84%) followed all their provider’s recommendations and trusted the information given to them (87%). State day care and pre-school requirements influenced vaccination decisions for nearly 80% of parents. Over 80% of parents thought it is important to protect against diseases covered by the vaccination schedule. One-third had at some time asked to delay or not administer vaccines; depending on the vaccine, up to 50% ultimately had their child vaccinated as recommended. Top reasons for delaying vaccination were to avoid crying and pain from multiple injections (82%), and the concern that too many vaccines would overwhelm the immune system (64%). Top reasons for refusal were religious views (57%) and the belief that the vaccine was not needed (52%). On average, parents would accept their child receiving 3 injections in one visit. Most parents were aware of combination vaccines (84%); however, one-third reported that their child had not received, or they were unaware of their child receiving, a combination vaccine. Conclusion Providers are in a strong position to influence vaccination decisions by parents. Whereas parents are motivated to avoid the pain of multiple injections, many are unaware that their children are receiving combination vaccines. Disclosures Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder) Xinyi Ng, PhD, Merck & Co., Inc. (Consultant) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Jyoti Aggarwal, MHS, Merck & Co., Inc. (Consultant) Jenna Bhaloo, MPH, Merck & Co., Inc. (Consultant) Michelle Goveia, MD, Merck & Co., Inc (Employee, Shareholder) David Johnson, MD, MPH, Sanofi Pasteur (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator)

scholarly journals 1386. Current Estimates of the Impact of Routine Childhood Immunizations in Reducing Vaccine-Preventable Diseases in the United States

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S703-S703
Author(s):  
Elizabeth M La ◽  
Justin Carrico ◽  
Sandra E Talbird ◽  
Ya-Ting Chen ◽  
Mawuli K Nyaku ◽  
...  
Keyword(s):  
United States ◽  
Research Study ◽  
Disease Incidence ◽  
Age Groups ◽  
Scientific Research ◽  
The United States ◽  
Annual Number ◽  
Study Investigator ◽  
Routine Childhood ◽  
The Impact

Abstract Background Routine immunizations for children aged 10 years and younger in the United States (US) currently cover 14 diseases. Updated estimates of public health impact are needed, given changes in disease epidemiology, evolving recommendations, and the dynamic nature of compliance with the immunization schedule. Methods Pre-vaccine disease incidence was estimated before each routine vaccine was recommended, with average values across multiple years obtained directly from published literature or calculated based on disease surveillance data or annual case estimates from the published literature. Pre-vaccine incidence then was compared to current, post-vaccine incidence, which was generally calculated as average values over the most recent 5 years of available incidence data. Overall incidence estimates and estimates by age group were calculated. Differences in pre- and post-vaccine disease incidence rates were used to calculate the annual number of cases averted, based on 2019 US population estimates. This analysis did not separately estimate the proportion of disease incidence reduction that may be attributed to adult vaccines or booster doses. Results Post-vaccine disease incidence decreased overall and for all age groups across all diseases evaluated (Table 1). Decreases ranged from 17.4% for influenza to 100.0% for polio (Figure 1). Over 90% reduction in incidence was achieved for 10 of the 14 diseases evaluated (including reduction in incidence of rotavirus hospitalizations). Overall post-vaccine disease incidence estimates were highest for influenza, rotavirus, and varicella. Estimated annual cases averted by vaccination in 2019 ranged from 1,269 for tetanus to more than 4.2 million for varicella. Table 1. Pre- and Post-Vaccine Disease Incidence Estimates, Annual Cases, and 2019 Cases Averted, by Disease Figure 1. Percentage Reduction in Disease Incidence Post-Vaccine, by Disease Conclusion Routine childhood immunization in the US continues to result in high, sustained reduction in disease across all vaccines and for all age groups evaluated. Disclosures Elizabeth M. La, PhD, RTI Health Solutions (Employee) Justin Carrico, BS, GlaxoSmithKline (Consultant) Sandra E. Talbird, MSPH, RTI Health Solutions (Employee) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Mawuli K. Nyaku, DrPh, Merck & Co. Inc. (Employee, Shareholder) Cristina Carias, PhD, Merck (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator) Craig S. Roberts, PharmD, MPA, MBA, Merck & Co., Inc (Employee, Shareholder)

scholarly journals 32. Host Immune-Protein Signature Combining TRAIL, IP-10 and CRP for Early and Accurate Prediction of Severe COVID-19 Outcome

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S22-S23
Author(s):  
Alon Angel ◽  
Niv Samuel Mastboim ◽  
Oded Shaham ◽  
Tahel Ilan Ber ◽  
Roy Navon ◽  
...  
Keyword(s):  
At Risk ◽  
Board Member ◽  
Research Study ◽  
Scientific Research ◽  
The United States ◽  
Blood Draw ◽  
Predictive Tool ◽  
Derivation Cohort ◽  
Study Investigator ◽  
Patients At Risk

Abstract Background Accurately identifying COVID-19 patients at-risk to deteriorate remains challenging. Dysregulated immune responses impact disease progression and development of life-threatening complications. Tools integrating host immune-protein expression have proven useful in determining infection etiology and hold potential for prognosticating disease severity. Methods Adults with COVID-19 were enrolled at medical centers in Israel, Germany, and the United States (Figure 1). Severe outcome was defined as intensive care unit admission, non-invasive or invasive ventilation, or death. Tumor necrosis factor related apoptosis inducing ligand (TRAIL), interferon gamma inducible protein-10 (IP-10) and C-reactive protein (CRP) were measured using an analyzer providing values within 15 minutes (MeMed Key®). A signature indicating the likelihood of severe outcome was derived generating a score (0-100). Description of derivation cohort RT-PCR, reverse transcription polymerase chain reaction. Results Between March and November 2020, 518 COVID-19 patients were enrolled, of whom 394 were eligible, 29% meeting a severe outcome. Age ranged between 19-98 (median 61.5), with 59.1% male. Patients meeting severe outcomes exhibited higher levels of CRP and IP-10 and lower levels of TRAIL (Figure 2; p < 0.001). Likelihood of severe outcome increased significantly (p < 0.001) with higher scores. The signature’s area under the receiver operating characteristic curve (AUC) was 0.86 (95% confidence interval: 0.81-0.91). Performance was not confounded by age, sex, or comorbidities and was superior to IL-6 (AUC 0.77; p = 0.033) and CRP (AUC 0.78; p < 0.001). Clinical deterioration proximal to blood draw was associated with higher signature score. Scores of patients meeting a first outcome over 3 days after blood draw were significantly (p < 0.001) higher than scores of non-severe patients (Figure 3). Moreover, the signature differentiated patients who further deteriorated after meeting a severe outcome from those who improved (p = 0.004) and projected 14-day survival probabilities (p < 0.001; Figure 4). TRAIL, IP-10, CRP and the severity signature score are differentially expressed in severe and non-severe COVID-19 infection Dots represent patients and boxes denote median and interquartile range (IQR) The signature score of patients meeting a severe outcome on or after the day of blood draw is significantly (p < 0.001) higher than the signature score of non-severe patients. Dots represents patients and boxes denote median and IQR Kaplan-Meier survival estimates for signature score bins Conclusion The derived signature combined with a rapid measurement platform has potential to serve as an accurate predictive tool for early detection of COVID-19 patients at risk for severe outcome, facilitating timely care escalation and de-escalation and appropriate resource allocation. Disclosures Alon Angel, n/a, MeMed (Employee, Shareholder) Niv Samuel Mastboim, BSc, MeMed (Employee, Shareholder) Oded Shaham, PhD, MeMed (Employee, Shareholder) Tahel Ilan Ber, MD, MeMed (Employee, Shareholder) Roy Navon, MSc, MeMed (Employee, Shareholder) Einav Simon, PhD, MeMed (Employee, Shareholder) Michal Rosenberg, PhD, MeMed (Employee) Yael Israeli, PhD, MeMed (Employee) Mary Hainrichson, PhD, MeMed (Employee, Shareholder) Noa Avni, PhD, MeMed (Employee) Eran Reiner, MD, MeMed (Employee) Kfir Oved, MD, PhD, MeMed (Board Member, Employee, Shareholder) Ilya Kagan, MD, MeMed (Scientific Research Study Investigator) Shaul Lev, M.D, MeMed (Scientific Research Study Investigator) Dror Diker, MD, MeMed (Scientific Research Study Investigator) Amir Jarjou’i, MD, MeMed (Scientific Research Study Investigator) Ramzi Kurd, MD, MeMed (Scientific Research Study Investigator) Guy Danziger, MD, MeMed (Scientific Research Study Investigator) Cihan Papan, MD, MeMed (Scientific Research Study Investigator) Sergey Motov, MD, MeMed (Scientific Research Study Investigator) Maanit Shapira, Ph.D, MeMed (Scientific Research Study Investigator) Tanya Gottlieb, PhD, MeMed (Employee, Shareholder) Eran Eden, PhD, MeMed (Board Member, Employee, Shareholder)

scholarly journals 1394. Impact of 7-Valent and 13-Valent Pneumococcal Conjugate Vaccines in the United States: A Systematic Literature Review

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S706-S706
Author(s):  
Kristin Kistler ◽  
Evelyn F Gomez-Espinosa ◽  
Kelly Sutton ◽  
Ruth Chapman ◽  
Desmond Dillon-Murphy ◽  
...  
Keyword(s):  
United States ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Pneumococcal Disease ◽  
Research Study ◽  
Scientific Research ◽  
The United States ◽  
Conjugate Vaccines ◽  
Pneumococcal Conjugate Vaccines ◽  
Study Investigator

Abstract Background The availability of 7-valent (PCV7) and 13-valent (PCV13) pneumococcal conjugate vaccines (PCVs) in the United States (US) since 2000 and 2010, respectively, has substantially reduced the occurrence, morbidity and mortality of pneumococcal disease. This systematic literature review aimed to assess the impact of the PCVs in reducing the pneumococcal disease burden since their introduction. Methods We searched Embase and Medline and disease-surveillance websites for observational studies of US participants < 19 years, published 1999–2019 and reporting incidence or prevalence of acute otitis media, invasive pneumococcal disease, meningitis, or pneumococcal disease-related morbidity, mortality, healthcare resource utilization (HCRU) or costs. Results Of 499 citations identified from the databases and other sources, 125 met inclusion criteria (Figure), all indicating clear reductions in multiple manifestations of pneumococcal disease with PCV7 and PCV13 use. However, variations across studies in outcomes reported, study years, and age strata, confounded assessment of vaccine impact on specific pneumococcal disease outcomes and key burden indicators, such as tympanostomy tube placement and antibiotic prescriptions. Conclusion PCVs have greatly decreased multiple manifestations of pneumococcal disease in the US. However, granular data on the frequency and morbidity associated with specific pneumococcal diseases and on associated HCRU are needed to quantify the public-health impact of these vaccines. Disclosures Kristin Kistler, PhD, Evidera, Inc. (Employee, Evidera, Inc. received the funding to conduct this study.) Evelyn F. Gomez-Espinosa, BSc, PhD, Evidera Inc (Employee, Scientific Research Study Investigator)Pfizer Inc (Consultant, Scientific Research Study Investigator) Kelly Sutton, PhD, Evidera (Other Financial or Material Support, Evidera, Inc. received the funding to conduct this study.) Ruth Chapman, MSc, PhD, Evidera, Inc, (Evidera, Inc. received the funding to conduct this study.) (Consultant) Desmond Dillon-Murphy, MSc, PhD, Evidera, Inc. (Evidera, Inc. received the funding to conduct this study.) (Consultant) Matthew Wasserman, MSc., Pfizer Inc. (Employee)

scholarly journals 26. Factors Associated with Meningococcal Vaccination among Patients with Newly Diagnosed High-Risk Conditions

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S37-S37
Author(s):  
Parinaz Ghaswalla ◽  
Lindsay Bengtson ◽  
Gary S Marshall ◽  
Ami R Buikema ◽  
Tim Bancroft ◽  
...  
Keyword(s):  
High Risk ◽  
Index Date ◽  
Research Study ◽  
Scientific Research ◽  
Administrative Claims ◽  
Pneumococcal Vaccines ◽  
Research Database ◽  
Newly Diagnosed ◽  
Factors Associated ◽  
Study Investigator

Abstract Background Vaccination is recommended for persons at increased risk for invasive meningococcal disease (IMD) due to complement component deficiency (CD), asplenia or human immunodeficiency virus (HIV) infection. However, uptake of quadrivalent conjugate and polysaccharide meningococcal vaccines (MenACWY) one year following a new high-risk diagnosis is very low (doi:10.1093/ofid/ofz360.2403). This retrospective cohort study identified factors associated with MenACWY vaccination among patients newly diagnosed with CD or HIV. Methods Patients identified from a large US commercial administrative claims database (Optum Research Database) with continuous enrollment for ≥12 months before and ≥6 months after appearance of an incident high-risk diagnosis through the end of the study period (3/31/2018) were considered eligible (Figure). Cox proportional hazards regression models were used to identify characteristics associated with time to receipt of ≥1 dose of MenACWY during time periods corresponding with Advisory Committee on Immunization Practices (ACIP) recommendations. Results The CD cohort consisted of 1,470 (mean=40.9 years of age) patients and the HIV cohort of 1,208 (38.8 years). Only 7.9% and 20.8% of patients with CD or HIV, respectively, received ≥1 dose of MenACWY between their index date and the end of the study period. A strong association between receipt of MenACWY and pneumococcal vaccines was seen for CD [hazard ratio (HR): 3.2; 95% CI: 1.8–5.7] and HIV [23.0; 13.9–38.1]. Age (11–18 years; for CD only) and having a well-care visit after the index date (for CD and HIV) was associated with higher likelihood of vaccination. Vaccination rates for HIV were lowest in the South. Conclusion The association of MenACWY vaccination with age in patients with CD suggests confusion between routine age-based and high-risk recommendations, whereas in patients with CD or HIV, the association with pneumococcal vaccines suggests that providers recognize the overlap in risk factors for IMD and pneumococcal disease. Ensuring healthcare access for these vulnerable patients and educating providers about high-risk recommendations is crucial. Funding GlaxoSmithKline Biologicals SA (study identifier: HO-18-19581) Disclosures Parinaz Ghaswalla, PhD, ORCID: 0000-0002-2883-5590, GlaxoSmithKline (Employee, Shareholder) Lindsay Bengtson, PhD, MPH, Optum (Employee, I am an employee of Optum. Optum was paid by GSK for this work. My employment at Optum is not contingent upon this work.) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator) Ami R. Buikema, MPH, Optum (Employee, I am an employee of Optum. Optum was paid by GSK for this work. My employment at Optum is not contingent upon this work.) Tim Bancroft, PhD, Optum (Employee, I am an employee of Optum. Optum was paid by GSK for this work. My employment at Optum is not contingent upon this work.) Krista Schladweiler, PhD, Optum (Employee, I am an employee of Optum. Optum was paid by GSK for this work. My employment at Optum is not contingent upon this work.) Eleena Koep, MS, Optum (Employee) Patricia Novy, PhD, GSK (Employee, Shareholder) Cosmina Hogea, PhD, GlaxoSmithKline (Employee, Shareholder)

scholarly journals 1150. Pediatric Osteoarticular Infections Caused by Mycobacteria Tuberculosis Complex: A Twenty-Six Year Review of Cases in San Diego, California

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S666-S667
Author(s):  
Ian Drobish ◽  
Nanda Ramchandar ◽  
Vanessa Raabe ◽  
Alice Pong ◽  
John S Bradley ◽  
...  
Keyword(s):  
Research Study ◽  
Bone Biopsy ◽  
Scientific Research ◽  
The United States ◽  
Sample Type ◽  
Tuberculosis Complex ◽  
Osteoarticular Infections ◽  
Study Investigator ◽  
Mycobacteria Tuberculosis ◽  
Culture Yield

Abstract Background Osteoarticular infections (OAI) account for 10-20% of extrapulmonary Mycobacteria tuberculosis (MTB) complex infections in children. Given the rarity of MTB OAI, the epidemiology, disease manifestations, and treatment are poorly characterized. We describe 21 children treated for MTB complex OAI over a 26-year period at a tertiary pediatric center in southern California. Methods We conducted a retrospective review of children diagnosed with MTB complex OAI and cared for between 31 Dec 1992 to 31 Dec 2018 at a single tertiary care pediatric hospital with close proximity to the United States-Mexico border. Results We identified 21 children with MTB complex OAI during the study period (Table 1). Concurrent pulmonary disease (4.8%), meningitis (9.5%), and intra-abdominal involvement (14.3%) were all observed. MTB complex was identified by culture from operative samples in 15/21 children (71.4%); 8/15 (51.3%) cultures were positive for Mycobacterium bovis. Of the eight cases of vertebral OAI (the most common site), one was culture-positive for M. bovis. Open bone biopsy was the most common procedure for procurement of a tissue sample and had the highest culture yield (Table 2). The median duration of antimicrobial therapy was 52 weeks (IQR 52-58). Successful completion of therapy was documented in 15 children (71.4%). Seven children (33.3%) experienced long term sequelae related to their infection. Table 1. Twenty-one children with Mycobacteria tuberculosis complex osteoarticular infections. Table 2. Surgical sample type and percent positivity. Conclusion Among the 21 children with MTB complex OAI assessed, 8 of 15 (53.3%) children with a positive tissue culture had M. bovis (intrinsically resistant to pyrazinamide), representing a higher percentage than in previous reports and potentially reflecting its presence in unpasteurized dairy products in the California-Baja region. Local epidemiological trends in endemic MTB complex species should be considered when evaluating and managing MTB complex OAI. Bone biopsy produced the highest culture yield in this study. Given the rarity of this disease, multicenter collaborative studies are needed to improve our understanding of the presentation and management of pediatric MTB complex OAI. Disclosures Vanessa Raabe, MD, MSc, Pfizer (Scientific Research Study Investigator, Other Financial or Material Support, Editorial support)Sanofi (Scientific Research Study Investigator)

scholarly journals 835. Improvement in Diet Attenuates Antiretroviral Therapy (ART) Associated Weight Gain in Persons with Human Immunodeficiency Virus (PWH)

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S509-S510
Author(s):  
Yesha Patel ◽  
Anjali Doshi ◽  
Anna Levesque ◽  
Shelsie Lindor ◽  
Robert Moranville ◽  
...  
Keyword(s):  
Weight Gain ◽  
Combination Therapy ◽  
Weight Change ◽  
Regression Models ◽  
Research Study ◽  
Scientific Research ◽  
Secondary Outcome ◽  
Factors Associated ◽  
Study Investigator

Abstract Background Weight gain among PWH on ART is a growing clinical concern. We explore factors associated with weight gain at The Ohio State University Wexner Medical Center Infectious Diseases Clinic. Methods This was a single-center, retrospective, cohort study of adult PWH on ART for at least 3 months seen at our clinic from 1/1/2015 to 1/1/2019. Patients with CD4+ T cell count < 200 cells/mm3, viral load >200 copies/mL, history of malignancy, or pregnancy were excluded. 870 patients met criteria. Patient demographics, lifestyle factors, medical co-morbidities, concurrent medications, and ART regimens were documented during the study period. The primary outcome was percent weight change over the follow up period. Secondary outcome was the odds of > 5kg weight gain over the study period. The effects of concurrent medications, medical comorbidities, ART combinations, and self-reported lifestyle behaviors on these outcomes were modeled using mixed effect linear and logistic regression analysis. Results At baseline, 83.6% were male, 29.2% were African American, and 65.6% had a body mass index ≥ 25 kg/m. Over a mean follow up of 1.86 years, the study population gained a mean percent weight of 2.12 ± 0.21% (p< 0.001) with an odds of weight gain >5kg of 0.293 (p< 0.001). Male sex and increasing age were significantly associated with a decrease in percent weight over the study period as reflected in the table below. Diet was also significantly associated with a decrease in percent weight change over the study period of -1.99 ± 0.47 %, p= < 0.001 and a lower odds of > 5kg of weight gain (OR= 0.70, 95% CI= 0.50 – 0.97, p=0.03). In regression models, combination therapy with tenofovir alafenamide (TAF) and integrase strand transfer inhibitor (INSTI) containing regimens were significantly associated with an increase in percent weight over the study period. Other significant factors including demographics and ART regimens are noted in Table 1. Table 1. Multivariable Regression Models* Conclusion Weight gain in PWH is multifactorial. Key factors associated with weight gain include combination therapy with TAF, particularly when combined with an INSTI. This data highlights the influential role of diet in PWH at risk of ART-associated weight gain. Disclosures Carlos Malvestutto, M.D., Lilly (Scientific Research Study Investigator)Regeneron Inc. (Scientific Research Study Investigator)ViiV Healthcare (Advisor or Review Panel member)

scholarly journals 1157. Clinical Safety, Efficacy, and Pharmacokinetics of Fosmanogepix, a Novel First-in-class Antifungal, in Patients with Renal Insufficiency: Subset Analysis from a Phase 2 Candidemia Trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S605-S605
Author(s):  
Pierre Bulpa ◽  
Galia Rahav ◽  
Ilana Oren ◽  
Mickaël Aoun ◽  
George R Thompson ◽  
...  
Keyword(s):  
Renal Function ◽  
Renal Insufficiency ◽  
Antifungal Agents ◽  
Research Study ◽  
Scientific Research ◽  
Panel Member ◽  
Antifungal Treatment ◽  
Successful Outcome ◽  
Review Panel ◽  
Study Investigator

Abstract Background Fosmanogepix (FMGX) is a first-in-class antifungal agent, with a unique MOA targeting the fungal enzyme Gwt1, and broad-spectrum activity against yeasts and molds, including fungi resistant to other antifungal agents. Patients with candidemia often have underlying renal insufficiency or are receiving medications that affect renal function. This analysis evaluated outcomes in patients with varying degrees of renal insufficiency. Methods This global, multicenter, open-label, non-comparative study evaluated the safety and efficacy of FMGX for first-line treatment of candidemia. Patients with a recent diagnosis of candidemia defined as positive blood culture for Candida spp within 96 hrs prior to study entry with ≤ 2 days of prior antifungal treatment were eligible, including those with renal insufficiency. Patients with neutropenia, C. krusei infection, deep-seated Candida infections or receiving hemodialysis were excluded. Subjects were treated with FMGX for up to 14 days: 1000 mg IV BID for 1 day, then 600 mg IV QD for at least 2 days, followed by either 600 mg IV QD or 700 mg PO QD. Patients requiring antifungal treatment beyond 14 days received fluconazole. The primary efficacy endpoint was outcome at end of study treatment (EOST) as determined by an independent data review committee. Successful outcome was defined as survival with clearance of Candida from blood cultures with no additional antifungal treatment. Results 14/21 (66%) subjects had some degree of renal insufficiency: 7 had mild renal insufficiency (GFR:60-89), 5 had moderate renal insufficiency (GFR:30-59), and 2 had severe renal insufficiency (GFR:15-29). 12/14 (86%) completed study treatment, and treatment was successful at EOST in 12/14 (86%) subjects. Decline in renal function was not observed at EOST. 4 had worsening of renal function during the follow-up period; none required dialysis. Renal impairment did not increase exposure of FMGX. There were no treatment-related adverse events. Conclusion FMGX demonstrated high level treatment success with no evidence of drug-related nephrotoxicity, with no dose adjustments required. These preliminary data support the continued evaluation of FMGX in patients with candidemia and renal dysfunction as an alternative to potentially nephrotoxic antifungal agents. Disclosures Pierre Bulpa, MD, Amplyx Pharmaceuticals (Scientific Research Study Investigator) Galia Rahav, MD, AstraZeneca (Scientific Research Study Investigator) Mickaël Aoun, MD, Amplyx Pharmaceuticals (Scientific Research Study Investigator) Peter Pappas, MD, SCYNEXIS, Inc. (Consultant, Advisor or Review Panel member, Research Grant or Support) Bart Jan Kullberg, MD, FRCP, FIDSA, Amplyx (Advisor or Review Panel member) Sara Barbat, BSN, RN, Amplyx Pharmaceuticals (Employee) Pamela Wedel, BSc, Amplyx Pharmaceuticals (Employee) Haran T. Schlamm, MD, Amplyx (Consultant) Michael Hodges, BSc. MD, Amplyx Pharmaceuticals Inc. (Employee)

scholarly journals 1608. Efficacy of Ceftolozane/Tazobactam for Multidrug-Resistant Gram-Negative Infections in Multiple Urban Hospitals

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S798-S799
Author(s):  
Nicolo Cabrera ◽  
Truc T Tran ◽  
Travis J Carlson ◽  
Faris Alnezary ◽  
William R Miller ◽  
...  
Keyword(s):  
Research Study ◽  
Clinical Success ◽  
Significant Proportion ◽  
Scientific Research ◽  
Panel Member ◽  
Multidrug Resistant ◽  
Outcome Data ◽  
Research Support ◽  
Gram Negative ◽  
Study Investigator

Abstract Background Ceftolozane/tazobactam (C/T) is a novel cephalosporin/beta-lactamase inhibitor combination developed for use against multidrug-resistant (MDR) Gram-negative infections, particularly Pseudomonas aeruginosa (PA). C/T is approved for complicated urinary tract and intraabdominal infections as well as hospital-acquired/ventilator-associated bacterial pneumonias. However, comprehensive clinical characterization of patients treated with C/T in non-FDA-approved indications is limited. Methods Patients ≥18 years who received C/T for ≥48 hours while hospitalized in 9 acute care centers in Houston, TX from January 2016 through September 2018 were included. Demographic, microbiologic, treatment and clinical outcome data were retrospectively collected by chart review. In patients who received multiple inpatient courses of C/T, only the first course with C/T was assessed. Results 210 patients met inclusion criteria: 58% were non-white, 35% were female and 13% were immunocompromised. Median age was 61 years (IQR, 48 to 69). Median Charlson comorbidity index was 5 (IQR, 2 to 6). At the onset of the index episode, a significant proportion of patients required intensive care unit admission (44%), mechanical ventilation (37%) and pressor support (22%). Respiratory sources were the most common (50%) followed by urine (15%). Positive cultures were documented in 93% of the cases and PA was found in 86%. Majority (95%) of PA which were MDR. C/T use was guided by susceptibility testing of the index isolate in ca. 52%. In 5.7% of cases, C/T was used to escalate therapy without any documented C/T-susceptible organism. Half (51%) of the cohort received initial dosing appropriate for renal function while 36% receiving a lower than recommended dose. Clinical success (i.e., recovery from infection-related signs and symptoms) occured in 77%. The in-hospital mortality rate in our cohort was 15% with 26 of 31 deaths deemed infection-related. Conclusion We report a large multicenter observational cohort that received C/T. A 77% clinical success with the use of C/T was documented. These data support the use of C/T in critically ill patients infected with MDR PA. Disclosures William R. Miller, MD, Entasis Therapeutics (Scientific Research Study Investigator)Merck (Grant/Research Support)Shionogi (Advisor or Review Panel member) Laura A. Puzniak, PhD, Merck (Employee) Cesar A. Arias, MD, MSc, PhD, FIDSA, Entasis Therapeutics (Scientific Research Study Investigator)MeMed (Scientific Research Study Investigator)Merck (Grant/Research Support)

scholarly journals 798. Metronidazole Exposure Prior to Clostridiodes difficile Infection (CDI) is a Risk Factor for Severe C. difficile Disease in Cancer Patients

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S442-S443
Author(s):  
Denise Marie A Francisco ◽  
Liangliang Zhang ◽  
Ying Jiang ◽  
Adilene Olvera ◽  
Eduardo Yepez Guevara ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Cancer Patients ◽  
Research Study ◽  
Research Support ◽  
Factors Associated ◽  
Patients With Cancer ◽  
Study Investigator ◽  
Severity Levels ◽  
Permutation Analysis

Abstract Background Antibiotic use is a risk factor for CDI. Few studies have correlated use of prior antibiotics with CDI severity in cancer patients. This study identified clinical and microbiology risk factors associated with severe CDI in patients with cancer. We hypothesized that previous antibiotic exposure and microbiome composition at time of CDI presentation, are risk factors for severe disease in cancer patients. Methods This non-interventional, prospective, single-center cohort study examined patients with cancer who had their first episode or first recurrence of CDI between Oct 27, 2016 and Jul 1, 2019. C. difficile was identified using nucleic acid amplification testing. Multivariate analysis was used to determine significant clinical risk factors for severe CDI as defined in the 2018 IDSA/SHEA guidelines. Alpha, and beta diversities were calculated to measure the average species diversity and the overall microbial composition. Differential abundance analysis and progressive permutation analysis were used to single out the significant microbial features that differed across CDI severity levels. Results Patient (n=200) demographics show mean age of 60 yrs., 53% female, majority White (76%) and non-Hispanic (85%). Prior 90 day metronidazole use (Odds Ratio OR 4.68 [1.47-14.91] p0.009) was a significant risk factor for severe CDI. Other factors included Horn’s Index > 2 (OR 7.75 [1.05-57.35] p0.045), Leukocytosis (OR 1.29 [1.16-1.43] p< 0.001), Neutropenia (OR 6.01 [1.34-26.89] p0.019) and Serum Creatinine >0.95 mg/dL (OR 25.30 [8.08-79.17] p< 0.001). Overall, there were no significant differences in alpha and beta diversity between severity levels. However, when identifying individual microbial features, the high presence of Bacteroides uniformis, Ruminococceae, Citrobacter koseri and Salmonella were associated with protection from severe CDI (p< 0.05). Table 1 - Results of multivariate logistic regression analysis of factors associated with severe CDI Figure 1. Microbiome features identified by progressive permutation analysis as seen in a volcano plot. Conclusion A number of risk factors for severe CDI were identified among this population, including prior 90 day metronidazole use. Also, increased relative abundance of Bacteroides uniformis, Ruminococceae, Citrobacter koseri and Salmonella were linked to protection from severe CDI. Reducing metronidazole use in patients with cancer may help prevent subsequent severe CDI. Disclosures Adilene Olvera, MPH MLS (ASCP), MERK (Grant/Research Support, Scientific Research Study Investigator) Kevin W. Garey, PharmD, MS, FASHP, Merck & Co. (Grant/Research Support, Scientific Research Study Investigator) Ryan J. Dillon, MSc, Merck & Co., Inc., (Employee) Engels N. Obi, PhD, Merck & Co. (Employee)

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