bluuebunny/crossref_metadata_2025_split huggingface dataset:
487. Experience with Remdesivir for Treatment of SARS-CoV-2 in Patients with Liver Cirrhosis
Authors: Saunders-Hao Patricia , Jain Sumeet , Hirsch Bruce , Gautam-Goyal Pranisha 
Published: December 2021

Abstract

Background
Remdesivir is a nucleotide analogue antiviral that was FDA approved for the treatment of hospitalized patients with coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). Remdesivir has been associated with elevations in serum aminotransferase levels but most cases being mild to moderate and reversible upon discontinuation. Although national COVID-19 guidelines and the American Association for the Study of Liver Diseases (AASLD) currently recommend remdesivir for use in hospitalized patients requiring supplemental oxygen, data is limited using remdesivir in patients with chronic liver disease. Here, we describe our experience with remdesivir in patients with liver cirrhosis.

Methods
Patients with liver cirrhosis who received remdesivir were identified either prospectively or retrospectively by primary or secondary ICD-10 codes indicating liver disease. Data collected included patient demographics, underlying cause of cirrhosis, co-morbidities, Child-Pugh score, laboratory values (serum aminotransferase levels, serum creatinine) during and following remdesivir, adverse reactions attributed to remdesivir, and mortality (in-hospital, 30-day, and 90-day).

Results
A total of 4 patients with underlying liver cirrhosis completed a 5-day course of remdesivir treatment. On admission, Child-Pugh class was A for 1 patient, B for 2 patients, and C for 1 patient. Causes for cirrhosis were nonalcoholic steatohepatitis (NASH), hepatic amyloidosis, and chronic hepatitis B. There were no acute elevations in aminotransferase levels or adverse events attributed to remdesivir therapy. Mortality was high with 50% in-hospital mortality. Of the 2 other patients who survived to discharge, one was discharged to home hospice and the other was readmitted within 30 days and expired during that admission.

Conclusion
Since there is limited data available using remdesivir in patients with advanced liver disease, we did not identify any safety concerns related to remdesivir in our cirrhotic patients. Mortality was high illustrating the poor outcomes of patients with advanced liver disease and COVID-19. Patients with cirrhosis should be offered remdesivir if clinically appropriate.

Disclosures
All Authors: No reported disclosures
489. SARS-CoV-2 Seroprevalence and Antibody Response Among Pregnant People in Seattle, WA
Authors: LaCourse Sylvia , Kachikis Alisa , Kinderknecht Kelsey L , Galang Romeo R , Zapata Lauren B , Yamamoto Krissy M , Salerno Carol C , Greninger Alexander L , Englund Janet A , Drake Alison 
Published: December 2021

Abstract

Background
Antenatal care is a unique opportunity to assess SARS-CoV-2 seroprevalence and antibody response in pregnant people, including those with previously unknown infection.

Methods
Pregnant people were screened for SARS-CoV-2 IgG during antenatal care or delivery in Seattle, Washington with Abbott Architect chemiluminescent immunoassay which provides quantitative index (positive ≥1.4). Participants with IgG+ results or identified with RT-PCR+ results via medical records were invited to enroll in a longitudinal evaluation of antibody responses. We report preliminary results of an ongoing seroprevalence and longitudinal study with planned 18-month follow-up.

Results
Between September 9, 2020–May 7, 2021, we screened 1304 pregnant people; 62 (4.8%) tested SARS-CoV-2 IgG+, including 28 (45%) with known prior SARS-CoV-2 infection. Among participants testing IgG+, median age was 32 years (interquartile range [IQR] 26–35) and median gestational age was 21 weeks (IQR 12–38) at screening; median IgG index was 3.2 (IQR 2.1–4.9, range 1.4–9.9), including 3.9 (IQR 2.3–5.8) among those with vs. 2.7 (IQR 1.9–4.2) among those without prior RT-PCR+ results (p=0.05 by Wilcoxon rank-sum). Of 30 longitudinal study participants enrolled, 24 tested IgG+ at baseline (75% with prior RT-PCR+ result) and 6 tested IgG- on enrollment but were identified as previously RT-PCR+ via medical records; 24/30 (80%) reported previous symptoms. Of 24 participants testing IgG+ at baseline, 14 (58%) had first follow-up IgG results at median of 66 days (IQR 42–104) since initial testing, with median IgG index of 2.0 (IQR 1.0–3.8). 9/14 (64%) participants with repeat IgG testing remained IgG+ at first follow-up (≤280 days after first RT-PCR+ result for those with and ≥104 days after first IgG detection for those without prior RT-PCR+ results), while 5/14 (26%) had a negative Abbott IgG test at a median of 81 days (IQR 75–112) since initial testing.

Conclusion
Nearly half of pregnant people testing SARS-CoV-2 IgG+ reported no known prior SARS-CoV-2 diagnosis or symptoms. SARS-CoV-2 IgG antibody response and durability in pregnancy has implications for maternal and neonatal protection and susceptibility and highlights potential benefits of vaccination in this population.

Disclosures
Sylvia LaCourse, MD, Merck (Grant/Research Support) Alisa Kachikis, MD, MS, GlaxoSmithKline (Consultant)Pfizer (Consultant) Alexander L. Greninger, MD, PhD, Abbott (Grant/Research Support)Gilead (Grant/Research Support)Merck (Grant/Research Support) Janet A. Englund, MD, AstraZeneca (Consultant, Grant/Research Support)GlaxoSmithKline (Research Grant or Support)Meissa Vaccines (Consultant)Pfizer (Research Grant or Support)Sanofi Pasteur (Consultant)Teva Pharmaceuticals (Consultant) Alison Drake, PhD, MPH, Merck (Grant/Research Support)
490. Uptake and Perceptions of COVID-19 Vaccines Among US Pregnant Women
Authors: Regan Annette , Swathi Pallavi Aytha , Nosek Marcianna , Gu Ning Yan 
Published: December 2021

Abstract

Background
Compared to the non-pregnant population, pregnant persons are at increased risk for severe COVID-19 related illness, including higher rates of admission to intensive care and greater mortality. Despite the potential benefits of COVID-19 vaccines for pregnant persons, current guidelines for the use of COVID-19 vaccines during pregnancy are limited, and the uptake of COVID-19 vaccines among US pregnant adults is unclear.

Methods
As part of an ongoing national longitudinal cohort study, 1,372 pregnant and recently postpartum pregnant persons participated in an online baseline survey, including questions on COVID-19 vaccination status and perceptions of COVID-19 vaccines. Preliminary analyses were restricted to 1,041 individuals who were pregnant during vaccine availability (after 14 December 2020). Post-stratification survey weights were applied to ensure results are representative of the general population. Weighted percentages and odds ratios were estimated based on survey responses.

Results
39.4% (95% CI 33.7, 45.1%) of respondents received a COVID-19 vaccine during pregnancy. Predictors of vaccination included belief that COVID-19 was a serious disease (OR 2.49; 95% CI 1.41, 4.11) and concerns about giving birth during the COVID-19 pandemic (OR 1.83, 95% CI 1.10, 3.04). The most common reason for receiving a COVID-19 vaccine was to protect themselves (21.2%) or their baby (39.1%). Among unvaccinated respondents, 14.9% planned to receive a vaccine during their pregnancy and 35.3% after pregnancy, 28.6% had no intention of receiving a vaccine, and the remaining 21.1% were uncertain. Among those who never planned to vaccinate, the most common reason was concern about side effects (57.2%). Percent of pregnant persons receiving at least one dose of COVID-19 vaccine, by month of delivery (postpartum participants) or estimated month of delivery (pregnant participants).

Conclusion
Our results indicate that despite the lack of clear recommendations for vaccination during pregnancy, more than one-third of pregnant persons received a COVID-19 vaccine during pregnancy. Evaluation of the health effects of COVID-19 vaccination during pregnancy, including the ability to protect pregnant persons and their infants from infection, is needed.

Disclosures
All Authors: No reported disclosures
492. Impact of the COVID-19 Pandemic on Diabetes Surrogate Markers in a Population of People Living with HIV
Authors: Maxwell Tyler , Kanner Esther , Hernandez Nubriel , Molino Suzanne , Yager Jessica E , Ramdeen Shannon , Sharma Roopali 
Published: December 2021

Abstract

Background
COVID-19 has become a worldwide pandemic that brought changes in sociological, economic and health perspectives. The impact of the pandemic on health maintenance is not yet understood, but aspects of the lockdown are being assessed for their impact on society. Diabetes and HIV are diseases that require frequent follow-up to achieve outcomes. Changes to routines during the lockdown, such as physical activity, eating habits, and psychological burden, may result in complications for this patient population.

Methods
This is a multi-center, retrospective cohort study performed between October 2019 to October 2020 at two medical centers in Brooklyn, NY. All adult patients with diagnoses of diabetes and HIV were screened for inclusion. Exclusion criteria included pregnancy and long-term steroid use. Electronic medical records were reviewed to obtain demographic, laboratory data, and appointment retention data. The primary endpoint was the mean change in HbA1c (A1c) values before and after the pandemic. Endpoints were evaluated using paired T-tests and Wilcoxon Sign-Rank tests, where appropriate, and a repeated measures logistic regression model was used to analyze appointment retention rates.

Results
Baseline characteristics are summarized in Table 1. No significance was observed between baseline A1c values and those taken either up to 3 months (p= 0.862) or up to 6 months (p= 0.977) after the start of the pandemic, as shown in Table 2. Similarly, no difference was observed in HIV surrogate markers. A1c significantly decreased from between the 3-month and 6-month study dates, after the start of the pandemic (p= 0.022). Table 3 shows patients were more likely to fulfill a scheduled appointment during the pandemic with an odds ratio of 1.455 (95% CI, 1.119-1.891).

Conclusion
No significance was found in surrogate markers for health maintenance before and after the pandemic. Patients were more likely to keep an appointment after the start of the pandemic and A1c values significantly declined from 3 months to 6 months into the pandemic. Although COVID-19 did not appear to change overall health maintenance of T2DM within our population, our results imply that pandemic measures, such as telehealth appointments, positively affected appointment adherence, which is key to success in this population.

Disclosures
Jessica E. Yager, MD MPH, Abbott Laboratories (Shareholder)Amgen Inc (Shareholder)Becton Dickenson & Co (Shareholder)Edwards Lifesciences Corp (Shareholder)Gilead Sciences, Inc. (Grant/Research Support, Recipient of FOCUS grant)
494. Characteristics and Outcomes of COVID-19 in Hospitalized Native American Patients: A Single-Site Retrospective Analysis
Authors: Jones T Shaifer , Stone Myles , Nham Amy , Bratsch Nicole A , Thompson Trevor N , Jentoft Christopher , Close Ryan M 
Published: December 2021

Abstract

Background
COVID-19 continues to threaten public health, particularly in Native American (NA) communities, which experienced some of the highest rates of COVID-19 infection and mortality in the US. Although the risk factors and clinical characteristics of COVID-19 are well documented in the general population, there has been little research on NA patients.

Methods
We present descriptive data based on chart reviews of COVID-19 patients hospitalized between April 1 and July 31, 2020 at the Whiteriver Service Unit (WRSU), an Indian Health Service site on the Fort Apache Reservation.

Results
Of the 2,262 COVID-19 cases during the observation period, 490 (22%) were hospitalized and 35 (1.6%) died within 28 days. Compared to previous reports, hospitalized patients at WRSU were younger (median age 54), more likely to be female (55% female), and more likely to have comorbidities (92% at least 1, median 2). Patients under 50 (n=200) often had a history of alcohol abuse (51%) or polysubstance abuse (20%). One third of hospitalized patients (34%) were monitored at home and referred for treatment through a high-risk outreach program. Patients were admitted much earlier at WRSU than in other locations, with a median interval of 4 days from symptom onset to hospitalization compared to 7 days reported elsewhere, but over half were still transferred to higher care. Although WRSU patients had higher rates of comorbidities, the 28-day hospital mortality rate from COVID-19 was nearly half of what has been previously reported (35/490, 7% vs 15-20% reported elsewhere, p &lt; 0.001). This trend persisted after controlling for age. Multivariate logistic regression showed that increasing age, male sex, and high BMI were significantly associated with higher risk of death from COVID-19 (overall model p &lt; 0.001).
Characteristics and outcomes of hospitalized COVID-19 patients at WRSU

Conclusion
Hospitalized patients at WRSU tended to be younger but with more comorbidities than previous studies. This may reflect the fact that NAs tend to acquire comorbidities at younger ages than the general population. This may also reflect the high rates of substance abuse in younger patients, which could be an additional risk factor for severe COVID-19. We believe that the low mortality rates at WRSU are a result of our outreach program, which likely decreased the interval between symptom onset and medical treatment.

Disclosures
All Authors: No reported disclosures
495. Evaluation of Antigen Testing for Detection of COVID-19 Vaccine Breakthrough Cases in Long-Term Care
Authors: Linder Meghan , Humphrey-King Sarah , Pierce Rebecca , Hearn Sheri L , Sutton Melissa , Sevey Shane , Fontana John , Cieslak Paul , Tran Dat 
Published: December 2021

Abstract

Background
Long-term care facilities (LTCFs) are at high risk for severe COVID-19 outbreaks due to their congregate nature and vulnerable population. Oregon Health Authority (OHA) deployed point-of-care antigen (Ag) tests to promptly identify COVID-19 cases in LTCFs. However, their performance in identifying vaccine breakthrough cases has not been evaluated.

Methods
During 2/25/21–5/25/21, OHA supported testing of residents and staff for two outbreaks at a single LTCF. Paired nasal swabs were collected and tested for SARS-CoV-2 by CDC Influenza SARS-CoV-2 Multiplex PCR Assay (molecular test) and Abbott BinaxNOW COVID-19 Ag Card (Ag test) twice weekly during the outbreaks. Participants were considered fully vaccinated if ≥ 14 days had passed since completion of a vaccine series; all others were deemed unvaccinated. A vaccine breakthrough case was defined as a positive Ag or molecular test from a fully vaccinated person’s specimen. Performance characteristics of the Ag test were assessed, with molecular test as the reference standard. Cycle threshold (Ct) values were compared by one-sided independent t-tests.

Results
94 unvaccinated residents and staff provided 563 paired samples; SARS-CoV-2 was detected in 21 (12 by Ag and molecular test, 6 by molecular test only, 3 by Ag test only), yielding Ag test sensitivity of 66.7% (95% CI: 43.8–83.7%) and specificity of 99.4% (95% CI: 98.4–99.8%). Mean Ct values were higher for specimens positive by PCR but negative by Ag than those positive by both (30.0 vs. 20.7, P &lt; .01). 81 vaccinated persons provided 925 paired samples; SARS-CoV-2 was detected in 5 (1 by Ag and molecular test, 4 by molecular test only), yielding Ag test sensitivity of 20% (95% CI: 3.6–62.5%) and specificity of 100% (95% CI: 99.6–100%). Mean Ct values for specimens from vaccinated cases were higher than those from unvaccinated cases (30.2 vs. 23.8, P &lt; .05). The lone Ag-positive breakthrough case had a Ct of 20; all others had Ct &gt; 29.

Conclusion
Ag test performance and reduced sensitivity on specimens with high Ct values found in this population are consistent with published data. Molecular testing maximizes identification of vaccine breakthrough cases. More studies are needed to estimate the proportion of breakthrough cases missed by Ag testing and their risk of transmitting the virus in LTCFs.

Disclosures
All Authors: No reported disclosures
497. Moderate Versus High Dose Corticosteroids in Adult Patients with Severe COVID-19: Less Is More
Authors: Joshi Seema , Soman Sana , Jain Saniya , Yako Atheel , Hojeij Marwa , Massoud Louis , Alsaadi Ayman , Smith Zachary R , Alangaden George J , Kenney Rachel , Mayur Ramesh 
Published: December 2021

Abstract

Background
The early administration of corticosteroids (CS) in patients with severe COVID-19 (hospitalized with need for supplemental oxygen) has been the only therapy to improve survival. However, the optimal dosing of CS remains unclear. Beginning March 2020 methylprednisolone (MP) in a dose of 40mg twice daily (high dose CS - HDC) was adopted at our institution. Based on emerging trials, this dose of MP was reduced to 16mg twice daily (moderate dose CS – MDC) in November 2020. The study aims to evaluate the outcome difference in patients receiving HDC versus MDC.

Methods
This pre-post quasi-experimental study was done at Henry Ford Hospital, an 877-bed tertiary care hospital in Detroit, Michigan. Consecutive patients in the HDC group from September 1, 2020 to November 15, 2020 were compared to the MDC group from November 30, 2020 to January 20, 2021. Only hospitalized patients with severe COVID-19 were included. The primary outcome was 28-day mortality. Secondary outcomes included progression to mechanical ventilation, length of hospital stay, discharge on supplemental oxygen and CS-associated adverse events. Patient demographics were evaluated using descriptive statistics. Bivariate and multivariable logistic regression analysis was planned to test the association between primary outcome and exposure.

Results
470 patients were evaluated, 218 and 252 in the HDC and MDC groups respectively. Clinical characteristics and severity of illness on admission were comparable in both groups (Table 1). Among comorbidities - lung disease, cardiovascular disease and hypertension were higher in MDC. Antibiotic and tocilizumab use were lower in MDC. Significantly more patients in MDC group received oral CS. There was no difference in mortality between HDC and MDC through bivariate and multivariate analysis (14.7% and 13.5%, p &lt; 0.712, adjusted OR 0.913 [0.514-1.619]) (Table 2,3). Median length of hospital stay was 5 and 6 days in HDC and MDC respectively (p &lt; 0.001). There was no difference in CS-associated adverse events.

Conclusion
The survival in severe COVID-19 patients treated with MDC is comparable to HDC. Oral corticosteroids are an equally effective option.

Disclosures
Rachel Kenney, PharmD, Medtronic, Inc. (Other Financial or Material Support, spouse is an employee and shareholder)
501. Implementation and Outcomes of a Program to Coordinate and Administer Monoclonal Antibody Therapy to Long-Term Care Facility Residents with COVID-19
Authors: Watkins Andrew B , Brand Lisa M , Schwedhelm Michelle , Jensen Heather L , Scott Brandon , German Dan K , Strand Kyle P , Kamal-Ahmed Ishrat , Lawler James , Salman Ashraf M 
Published: December 2021

Abstract

Background
Long-term care facility (LTCF) residents are at increased risk of severe COVID-19, with CMS data indicating &gt; 20% mortality. BLAZE-1 trial noted lower hospitalization rates in high-risk patients receiving monoclonal antibody (mAb) vs placebo (4.2% vs 14.6%) for mild to moderate infections, making it a treatment option for LTCF residents; however, many LTCF lack staff to prepare and administer mAb therapy. To address this need, Region VII Disaster Health Response Ecosystem (R7DHRE) coordinated via NE Medical Emergency Operations Center (NEMEOC) an ASPR pilot project to facilitate infusion of COVID-19 mAb therapeutics for LTCF residents in the state.

Methods
R7DHRE partnered with Great Plains Health, Nebraska DHHS, Nebraska Antimicrobial Stewardship Assessment and Promotion Program (ASAP) and Infection Control Assessment and Promotion Program (ICAP) to surveil cases in the state, establish distribution/administration pathways, and educate providers on mAb therapeutics. A multi-hub-and-spoke model was created to allow LTCF to work with regional hospitals or pharmacy services to administer drug in their facilities, reducing time to therapy and transmission risk associated with patient transport. A centralized request process was created using a REDCap platform and verification of patient eligibility by ASAP. This request link, informational documents, fact sheets, and custom-built order form templates were hosted on a dedicated ASAP webpage, and details were shared during weekly ICAP LTCF webinars. Outcomes data, including 14- and 28-day COVID-related hospitalizations and mortality, were collected using databases from Nebraska Health Information Initiative and Nebraska DHHS.

Results
Through this program, 513 doses were administered to LTCF residents. Average time from symptom onset to infusion was 2.6 days. COVID- related hospitalization and mortality rates were lower than previously reported for LTCF residents (Table 1).
Table 1. Debographics and Outcomes of mAb Infusions

Conclusion
By utilizing existing relationships with LTCFs in the region, we established a program to promptly distribute, prepare, and administer monoclonal antibody therapy to LTCF residents in need, preventing COVID-related hospitalizations and deaths.

Disclosures
James Lawler, MD, MPH, FIDSA, Kinsa Health (Advisor or Review Panel member)Takeda Pharmaceuticals (Advisor or Review Panel member) M. Salman Ashraf, MBBS, Merck & Co. Inc (Grant/Research Support, I have recieved grant funding for an investigator initiated research project from Merck & Con. Inc. However, I do not see any direct conflict of interest related to the submitted abstract)