bluuebunny/crossref_metadata_2025_split huggingface dataset:
468. Associations of Socioeconomic Status and Care Access Measures with COVID-19 Testing in Patients with Breast Cancer
Authors: Freeman Jincong Q , Li Xinyi , Lee Yong Gun , Akhiwu Ted O 
Published: November 2023

Abstract

Background
Breast cancer patients (BCpts) are vulnerable to COVID-19 infection and hospitalization. COVID-19 testing and early detection are critical but can be hindered by socioeconomic status (SES) and care access measures (CAM)-related barriers. Little is known about how SES and CAM affect COVID-19 testing in BCpts at the national level.

Methods
We analyzed data collected from stage I-IV BCpts in the 2020 National Cancer Database, a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. Multivariable logistic regression was used to examine the associated SES and CAM with COVID-19 testing.

Results
Of 115,948 BCpts (mean age 61.7 years [SD=13.2]), 75.5% were White, 12.3% Black, 3.8% Asian or Pacific Islander (API), 6.6% Hispanic, and 1.8% American Indian or Alaska Native (AIAN). Overall, 79.3% received a COVID-19 test. Compared with White BCpts, API (adjusted odds ratio [AOR]=1.15, 95% CI=1.05-1.26) or Hispanic (AOR=1.24, 95% CI=1.15-1.34) BCpts were more likely, while AIAN BCpts were less likely (AOR=0.89, 95% CI=0.79-0.99), to be tested. No significant differences in testing were observed between Black and White BCpts (AOR=0.98, 95% CI: 0.93-1.04). Uninsured BCpts were less likely than those insured to receive testing (AOR=0.82, 95% CI=0.72-0.93). BCpts residing in Medicaid non-expansion states had lower odds of testing than those in expansion states (AOR=0.89, 95% CI=0.86-0.92). BCpts with a median household income of &lt; $46,227 (AOR=0.79, 95% CI=0.74-0.83), $46,227-57,856 (AOR=0.82, 95% CI=0.78-0.86) or $57,857-74,062 (AOR=0.82, 95% CI=0.79-0.86) were less likely than those with ≥ $74,063 to get tested. BCpts in urban (AOR=0.81, 95% CI=0.77-0.86) or rural (AOR=0.69, 95% CI=0.61-0.78) areas had lower odds of testing than those in metro areas. Compared with BCpts seeking care at academic/research cancer programs, those at community (AOR=0.71, 95% CI=0.67-0.76) or comprehensive community (AOR=0.79, 95% CI=0.76-0.82) programs were less likely to receive a test.

Conclusion
In this cohort of BCpts, one in 5 were not tested for COVID-19, and they were more likely from a lower SES or to have greater CAM-related barriers. Equitable access to COVID-19 testing is needed to address barriers and better reach this population of BCpts.

Disclosures
All Authors: No reported disclosures
474. Real-World Experience of the Comparative Effectiveness and Safety of Remdesivir and Combination Therapy (Remdesivir and Monoclonal Antibodies) in Immunosuppressed Patients with Mild to Moderate COVID-19: A Retrospective Single-center Study in a Community Setting
Authors: Hirai Jun , Mori Nobuaki , Sakanashi Daisuke , Asai Nobuhiro , Hagihara Mao , Mikamo Hiroshige 
Published: November 2023

Abstract

Background
Although several treatment options have been developed for COVID-19, there are still significant challenges in treating certain immunosuppressed patient populations. The objective of this retrospective observational study was to evaluate and compare the effectiveness and safety of immunosuppressed COVID-19 patients treated with remdesivir alone or combination therapy (remdesivir and monoclonal antibodies).

Methods
We included immunosuppression patients who had at least one risk factor for progression to severe COVID-19 from July 2021 to March 2023. The definition of an immunosuppression patient was follows: an autoimmune disease with immunosuppressive therapy, a kidney transplant with an immunosuppressive agent, or having a solid tumor or blood cancer. REGN-COV2 (casirivimab and imdevimab) was prescribed during the Delta strain epidemic season while sotrovimab was prescribed during the Omicron BA1 strain epidemic season. Treatment for each group was initiated within 7 days of symptom onset. We evaluated the time to the resolution of fever over 24 hours after treatment initiation and the Ct value in the study patients.

Results
We enrolled 86 patients who met the inclusion criteria, of whom 35 received combination therapy (CT group) and 51 received remdesivir alone (MT group). No significant difference was observed between the two groups with regard to laboratory data and underlying diseases. There was no difference regarding the duration of remdesivir administration, non-vaccinated population, and number of vaccination between the two groups. A statistically significant reduction in fever of more than 24 hours was achieved in the CT group compared to the MT group (p = 0.01). The CT group patients showed a steeper viral load reduction with respect to the MT group (p = 0.026). Adverse events such as liver dysfunction and kidney disease occurred in only one patient in each group. On comparing both groups, the duration of hospital stay, the ratio of exacerbation, death by COVID-19, and 30-day all-cause mortality did not differ significantly.
The presentstudy cohort

Conclusion
By evaluating the effectiveness of combination therapy with remdesivir and monoclonal antibodies, our study has the potential to improve clinical outcomes and reduce the burden of COVID-19 in this vulnerable population.

Disclosures
Hiroshige Mikamo, M.D, Ph.D, Asahi Kasei Pharma Corporation: Grant/Research Support|Merck Sharp & Dohme: Honoraria|Pfizer Inc.: Grant/Research Support|Pfizer R&D Japan: Honoraria|Sumitomo Pharma Co., Ltd.: Grant/Research Support|Sumitomo Pharma Co., Ltd.: Honoraria
490. Identifying and Evaluating the Drivers of COVID-19 Vaccine Hesitancy Among Individuals with HIV in New Jersey
Authors: Occhiogrosso Jessica , Rijhwani Leena , Rijhwani Divya , Rajagopalan Aravind , Fox Theresa C , Marone Roseann , Burack Gail , Gaur Sunanda , Bhowmick Tanaya 
Published: November 2023

Abstract

Background
Vaccine hesitancy, defined as the “delay in the acceptance or refusal of vaccines despite availability,” has been a significant challenge to vaccine uptake during the COVID-19 pandemic. Few studies have examined COVID-19 vaccine hesitancy among Americans living with HIV, a population with increased vulnerability to severe infection.

Methods
We conducted a cross-sectional phone survey of 69 adults diagnosed with and receiving longitudinal care for HIV across 3 Ryan White HIV/AIDS Program-funded medical facilities in New Jersey. Surveys were administered from July 2022 to February 2023. Questions targeted COVID-19 vaccination status and concerns, factors that influenced vaccination decisions, and HIV stigma. Participant demographics and medical history were retrieved from the Ryan White Program’s CAREWare database. Data was summarized with descriptive statistics and bivariate correlations, and assessed for mean differences between “low” and “high” average vaccine hesitancy.

Results
Among 69 participants, 96% received ≥1 COVID-19 vaccine and 81% received ≥1 booster (Table 1). 87% were motivated to get vaccinated because it was “necessary due to their health status,” and 70% cited the healthcare team as a “very significant” influence on opinions regarding COVID-19 vaccination. 37 of 69 participants reported higher average vaccine hesitancy (avg. rating &gt; 2.5 out of 5) and thought the healthcare system was less likely to protect their privacy (p = 0.029). No significant difference was noted in HIV stigma, CD4 count, or years on ART between more vs. less hesitant groups. Additionally, participants who were strongly inclined to follow vaccine recommendations from their HIV care provider were more likely to believe that vaccination is important for disease prevention and protection (p &lt; 0.001 for both), and more likely to have received a booster (p &lt; 0.001).
Table 3: strength of associations between those who reported to "generally follow" what their doctor or health care provider recommends about vaccines for their health and specific beliefs about vaccination.

Conclusion
While most participants reported some degree of vaccine hesitancy, their level of hesitancy was not linked to disease-specific variables such as CD4 count, viral load, years on ART, or HIV stigma. However, most participants reported following vaccine recommendations from their HIV care provider, underscoring healthcare professionals’ critical role in vaccine education among people living with HIV.

Disclosures
Tanaya Bhowmick, MD, Shinogi: Advisor/Consultant
496. Maternal Participation in Enrollment Interview and Risk of Bias in a Multicenter Pediatric Network Evaluating COVID-19 Vaccine Effectiveness in Infants
Authors: Simeone Regina , Zambrano Laura D , Newhams Margaret M , Halasa Natasha B , Fleming-Dutra Katherine E , Orzel Amber , Wu Michael J , Randolph Adrienne G , Campbell Angela P 
Published: November 2023

Abstract

Background
The Overcoming COVID-19 network uses a case-control design to estimate effectiveness of maternal COVID-19 vaccination on COVID-19 associated hospitalization of infants. Vaccination history is asked in a maternal interview and verified with jurisdictional immunization information systems (IIS). In the absence of an interview, IIS data alone are used. These data may become less complete as the public health emergency ends and COVID-19 vaccines move to the commercial market. Vaccination status may rely more on interviews, potentially biasing VE estimates. We analyzed possible future participation bias.

Methods
Maternal interview participation was assessed for 699 case infants &lt; 6 months hospitalized with COVID-19 and 613 SARS-CoV-2 test-negative control infants &lt; 6 months with COVID-like illness admitted to 29 U.S. hospitals from December 19, 2021–January 31, 2023. To assess recent changes in participation, two Omicron subvariant periods were defined: Period 1 (December 19, 2021–July 18, 2022) and Period 2 (July 19, 2022–January 31, 2023). Interview participation percentages for vaccinated and unvaccinated cases and controls, overall and by subvariant, were used to calculate interview participation bias factors (BF) (Table 1). The BF can be used to adjust observed estimates of VE for potential participation bias.

Results
Overall, vaccination was more frequent among participating case (25%) vs. non-participating case (16%) mothers (Table 2). Vaccination status did not differ by interview participation among controls. Participation was highest in Period 1 (68% in vaccinated cases) and lowest in Period 2 (31% in vaccinated controls) (Table 3). During Period 1, the BF was 1.0, suggesting no participation bias would occur by limiting to interviewed participants. During Period 2, the BF was 1.9. Independent of other possible biases, differences in participation by case/control and vaccination status would be biased by a factor of 1.9, lowering the observed VE.

Conclusion
Participation in the interview differed by case/control and vaccination status during recent Omicron subvariant circulation. Independent of other biases, our results suggest that future estimates of maternal VE could be biased if future estimates of maternal VE include only women who complete an interview.

Disclosures
Regina Simeone, PhD, Pfizer: Stocks/Bonds Natasha B. Halasa, MD, MPH, Merck: Grant/Research Support|Quidell: Grant/Research Support|Quidell: donation of kits|Sanofi: Grant/Research Support|Sanofi: vaccine support
504. Individual and Neighborhood Factors Associated with Failure to Vaccinate Against COVID-19 Among Pregnant Persons
Authors: Zerbo Ousseny , Ray Thomas , Fireman Bruce , Layefsky Evan , Goddard Kristin , Ross Pat , Greenberg Mara , Klein Nicola P 
Published: November 2023

Abstract

Background
Pregnant persons are at increased risk of complication from COVID-19. Vaccine coverage among pregnant persons has been low. The overall goal of this study was to determine whether unvaccinated pregnant persons cluster geographically and to assess individual and neighborhood factors associated with failure to vaccinate.

Methods
The study setting was Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery organization that provides comprehensive care to approximately 4.4 million members. This study included a cohort of pregnant persons who delivered between December 15, 2020 and September 30, 2022. Pregnant persons were considered vaccinated if they received mRNA COVID-19 vaccines any time before or during pregnancy. We used spatial scan statistics to identify geographical clusters of unvaccinated pregnant persons and determined individual and neighborhood factors associated with failure to vaccinate using multivariate logistic regression.

Results
Among 85,852 pregnant persons residing in Northern California, 46.6% were unvaccinated. Spatial analysis identified 5 clusters with high prevalence of unvaccinated pregnant persons. The proportion of unvaccinated ranged from 53% to 62% within clusters compared with 39% outside clusters. In covariate-adjusted analyses, residence in a cluster decreased the odds of vaccination by 1.64 (95% confidence interval (CI): 1.59 - 1.69). The odds of vaccination also decreased with black race (OR=1.45, 95% CI: 1.37 - 1.54), subsidized insurance (OR = 1.32, 95% CI: 1.26 – 1.38) and living in neighborhoods with high proportion of adults with high school education or less. The Odds of vaccination decreased by 1.21 (95% CI: 1.15 – 1.26), 1.36 (95% CI 1.29 – 1.44) and 1.43 (95% CI 1.34 – 153) for pregnant persons living in neighborhoods where the proportion of adults with high school education or less was 20% to &lt; 30%, 30% to &lt; 43% and ≥43%, respectively.

Conclusion
Almost half of pregnant persons, members of Kaiser Permanente in Northern California, were unvaccinated against COVID-19. Unvaccinated pregnant persons clustered geographically and by some sociodemographic factors. Interventions to increase COVID-19 vaccine coverage among pregnant persons are needed, particularly among vulnerable pregnant populations.

Disclosures
Nicola P. Klein, MD, PhD, GlaxoSmithKline: Grant/Research Support|Merck: Grant/Research Support|Pfizer: Grant/Research Support|Sanofi Pasteur: Grant/Research Support
509. A Comparison of Tocilizumab and Baricitinib for Hospitalized Patients with Severe COVID-19
Authors: Aytoda Priyanka , Albrecht Benjamin , Green Sarah B , Harris Gavin , Busch Lindsay M , Sexton Mary Elizabeth , Wiley Zanthia , Rimawi Ramzy H 
Published: November 2023

Abstract

Background
Baricitinib (BARI) and tocilizumab (TOCI) are two FDA-approved immunomodulating agents for the treatment of COVID-19 patients with worsening respiratory status, but early studies suggest no differences in outcomes between the two therapies.

Methods
This is a single-center retrospective analysis of adult patients who received TOCI or BARI for severe COVID-19 from April 2021 to February 2022. Severe COVID-19 was defined as having a National Institute of Allergy and Infectious Disease (NIAID) Ordinal Scale (OS) score of 6 or 7 as described in the Table I. The primary outcome was days to clinical improvement defined as a reduction by ≥ 2 scores on the NIAID OS after the first dose of TOCI or BARI (Day 1) and analyzed using a stratified log-rank test with stratification by the Day 1 NIAID OS score of 6 or 7. Patients who did not show clinical improvement were removed from this analysis. Secondary outcomes include hospital and intensive care unit (ICU) length-of-stay (LOS) and adverse events (AE). Categorical variables were analyzed using Chi-square or Fisher’s exact test, and continuous variables were analyzed using Student’s t-test or Mann-Whitney U test as appropriate.

Results
A total of 258 patients met inclusion criteria (121 BARI; 137 TOCI). Of patients receiving NIV/HFO (n=224) or MV/ECMO (n=34) at baseline, 33.9% and 71% of patients did not show clinical improvement, respectively. The time to clinical improvement did not differ significantly between BARI and TOCI in patients with baseline NIV/HFO (11.9 vs. 12.6 days respectively; p=0.79). A significant difference in days to clinical improvement was observed in MV/ECMO patients who received BARI or TOCI (7.0 vs. 25.7 days respectively; p=0.04). Hospital LOS, ICU LOS, and AE were similar between groups. Mortality rates were higher in patients who had MV/ECMO at baseline compared to those who received NIV/HFO (50% vs 20.1%, p &gt;0.05), but there were no significant differences in mortality between treatment groups.

Conclusion
Days to clinical improvement did not differ between TOCI and BARI. A significant difference in days to clinical improvement was observed in the MV/ECMO group. However, application of this finding to clinical practice in patients with MV/ECMO is limited due to a small subgroup size and low rates of survival.

Disclosures
All Authors: No reported disclosures
537. Safety and Effectiveness of Ensitrelvir for the Treatment of COVID-19 in Japanese Clinical Practice: A Post-marketing Surveillance (Interim Analysis)
Authors: Ogura Eriko , Nakagawa Noriko , Hayashi Noriko , Tsukimura Eri , Takashima Satoru 
Published: November 2023

Abstract

Background
Ensitrelvir fumaric acid (ensitrelvir) is a novel anti-SARS-CoV-2 drug and an inhibitor of SARS-CoV-2 3CL protease. Emergency regulatory approval was obtained in Japan in November 2022. Post-marketing surveillance (PMS) is currently on-going to evaluate safety and effectiveness of ensitrelvir in Japanese real world clinical practice.

Methods
In the PMS, 3000 COVID-19 patients who were administered ensitrelvir for the first time in about 500 Japanese hospitals or clinics are to be enrolled and observed for 28 days after the first administration. Patient demographics, concomitant medications, other therapy for COVID-19, adverse events, and clinical course (body temperature, presence or absence of systemic symptoms, respiratory symptoms, and gastrointestinal symptoms) are to be investigated.

Results
Of the 234 cases collected by March 2023, 226 cases were included in the safety and effectiveness analysis population. Among the 226 cases, the average age was 43.5 years (the median age was 44.0 [12 - 91] years); 24 cases (10.6%) were aged 65 and over; and 115 cases (50.9%) were male. There were 44 cases (19.5%) with high-risk factors for severe illness. The severity of COVID-19 was mild in all cases.
Of the 226 cases in the safety analysis population, 34 events of non-serious adverse drug reactions were reported, and no cases/events of serious adverse drug reactions were reported. The major adverse drug reactions were diarrhea in 9 cases (4.0%), nausea in 4 cases (1.8%), and aggravation of bronchial asthma in 4 cases (1.8%). Two cases (0.9%) were hospitalized, and the reason for hospitalization was exacerbation of COVID-19 in both cases. No death cases were reported. The median time to resolution of fever was 36.0 hours in the standard-risk group (n=136) and 24.0 hours in the high-risk group (n=32). The median time to resolution of all symptoms was 144.0 hours in the standard-risk group (n=182) and 108.0 hours in the high-risk group (n=44).
In this presentation, results of the interim analysis on cases that have been collected by May 2023 will be reported.

Conclusion
Results of the interim analysis suggest that ensitrelvir is well tolerated and effective in patients with or without risk factors.

Disclosures
Eriko Ogura, MD, Shionogi & Co., Ltd.: I am an emplyee of Shionogi & Co., Ltd. Noriko Nakagawa, n/a, Shionogi & Co., Ltd.: I am an employee of Shionogi & Co., Ltd. Noriko Hayashi, n/a, Shionogi & Co., Ltd.: I am an emplyee of Shionogi & Co., Ltd.|Shionogi & Co., Ltd.: I am an emplyee of Shionogi & Co., Ltd. Eri Tsukimura, n/a, Shionogi Pharmacovigilance Center Co., Ltd.: I am an employee of Shionogi Pharmacovigilance Center Co., Ltd. Satoru Takashima, n/a, Shionogi & CO., LTD.: I'm an employee of Shionogi & CO., LTD.
543. Sex Differences in Clinical Presentation and Outcomes of Adults Hospitalized with COVID-19 Pneumonia After Administration of Infliximab, Abatacept or Cenicriviroc: Subgroup Analysis from the ACTIV-1 Master Protocol
Authors: Rauseo Adriana , Der Tatyana , Alicic Radica , Balani Bindu , Morse Caryn , Zakroysky Pearl , Shaw Linda , Atkinson Jane , Powderly William G 
Published: November 2023

Abstract

Background
A growing body of evidence suggests potential sex differences in the clinical outcomes of COVID-19. In this study we evaluated whether sex and baseline clinical variables were associated with treatment effect after receipt of immunomodulators vs placebo in a study population derived from ACTIV-1 IM clinical trial.

Methods
ACTIV-1 IM is a master protocol that evaluated infliximab, abatacept and cenicriviroc in addition to standard of care in adult patients hospitalized with moderate or severe SARS-CoV-2 infection through randomized, double-blind comparisons to shared placebo. We performed a subgroup analysis of the modified intention-to-treat cohort. Primary outcome was association of sex with time-to-recovery at day 28, key secondary outcomes were 28-day mortality and clinical status at day 14.

Results
A total of 1381 participants were included. There was no difference in treatment effect for primary endpoint of time-to-recovery based on sex for infliximab (RRR 1.14, 95% CI 0.95-1.37 for males and RRR 1.09, 95% CI 0.90-1.34 for females with interaction p=0.77), abatacept (RRR 1.14, 95% CI 0.95–1.37 for males and RRR 1.13, 95% CI 0.91-1.40 for females with interaction p=0.93) or cenicriviroc (RRR 0.99, 95% CI 0.79–1.24 for males, RRR 0.98, 95% CI 0.77-1.24 for females, interaction p=0.93) substudies. There was no difference in treatment effect by sex for secondary outcomes for infliximab and abatacept substudies. The cenicriviroc substudy was terminated early for futility and found no difference in treatment effects based on sex for secondary outcomes either.

Conclusion
There was no difference in treatment effect for infliximab, abatacept or cenicriviroc among males vs females. This suggests a more complex interplay of pathogen and host factors deserving further research to identify therapeutic targets for COVID-19.

Disclosures
Radica Alicic, MD, MSc, Boehringer Ingelheim Pharmaceuticals, Inc.: Advisor/Consultant Caryn Morse, MD, Gilead Sciences Inc.: Grant/Research Support|Janssen: Grant/Research Support|Laurent Pharma: Grant/Research Support|Moderna: Grant/Research Support|Ridgeback Bio: Grant/Research Support William G. Powderly, MD, Merck: Advisor/Consultant