bluuebunny/crossref_metadata_2025_split huggingface dataset:
2497. Analysis of Social Determinants of Health (SDOH) and their Implications for Hepatitis C Treatment in People Who Inject Drugs: The Case of Baltimore
Authors: Corro Luis A Gonzalez , Falade-Nwulia Oluwaseun , Page Kathleen R , Lucas Gregory 
Published: November 2023

Abstract

Background
Of 3.5 million people living with HCV in the US, nearly 60% are people who inject drugs (PWID). Despite the availability of a cure for HCV, uptake remains low in PWID. We set out to study the social determinants of health (SDOH) that impact the HCV care cascade.

Methods
We conducted a secondary analysis of baseline data from 720 PWID in a cluster-randomized trial. We recruited PWID via an outreach van from 12 drug-affected areas in Baltimore City. Inclusion criteria included injection in the prior month or needle sharing in the past 6 months. An intake visit included a survey and a blood draw for HCV testing (serology reflexed to HCV RNA). Focusing on SDOH, we analyzed factors related to self-report of i) awareness of HCV infection (in the subgroup with active or treated HCV) and ii) prior HCV treatment (in the subgroup that was aware of their HCV infection). We used descriptive statistics and logistic regression for statistical analyses.

Results
The 342 PWID included in our study had a median age of 52 years and most were male and Black. 53% injected daily and 67% reported receptive needle sharing in the past 6 months. Of 251 who were aware of their HCV infection, 34% reported treatment.
Women were more likely to be aware of their status but less likely to be treated. Older age and Black race were both associated with increased odds of HCV treatment (with evidence of confounding as the median age was 8 years lower in white vs. Black people). Having a primary care provider and HIV+ status (a likely proxy for care access) were both significantly tied to higher odds of awareness and of treatment. Unhoused people had 51% lower odds of HCV treatment (vs. stably housed). Finally, we found a positive link to social support: people who reported that other PWID had shared their HCV+ status with them had 2.3-fold higher odds of awareness of their own status. Similarly, people with ≥ 3 (median) close people to talk to had over twice the odds of HCV treatment (vs. &lt; 3) in an unadjusted model.

Conclusion
In this study of street recruited PWID, we observed a lower treatment uptake in women despite greater HCV infection awareness. SDOH categories with significant associations to the HCV care cascade included finances, stigma, support system, healthcare usage, and housing status. Strategies to not only identify but address SDOH are vital to end HCV.

Disclosures
Oluwaseun Falade-Nwulia, MBBS ,MPH, Abbvie Inc: Grant/Research Support|Gilead Sciences: Advisor/Consultant
2500. An Audit of Hepatocellular Carcinoma Surveillance amongst Patients with Chronic Hepatitis B Attending an Irish Tertiary Centre
Authors: Heeney Aoife , Chianain Aine Ni , McNally Cora 
Published: November 2023

Abstract

Background
The association between chronic hepatitis B (CHB) and hepatocellular carcinoma (HCC) is well established, however it can be challenging to identify those who require surveillance. The European Association for the Study of the Liver (EASL) guidelines recommend 6-monthly liver ultrasound (US) as the optimal surveillance method and using the PAGE-B score for HCC risk stratification. This score offers good predictability for HCC whilst on nucleoside analogue therapy, and it also appears reliable in untreated patients. It has also been validated for individuals with HIV/HBV coinfection. We aimed to assess the compliance of an Irish tertiary hospital with the EASL guidelines for HCC surveillance.

Methods
We carried out a retrospective review of electronic medical records of patients with CHB attending the infectious diseases outpatient clinic in Beaumont Hospital, Dublin, Ireland.

Results
70 patients were included, of which 20 were co-infected with HIV. Of the 50 patients with CHB monoinfection, 4% (n=2) had cirrhosis and 20% (n=10) were on treatment. 98% (n=49) were undergoing surveillance with 90% undergoing 12-monthly US. We analysed each patient's PAGE-B score from their most recent clinic data and 6 (12%) were stratified as high risk, 24 (48%) as medium risk and 20 (40%) as low risk. Of those coinfected with HIV, 15% (n=3) patients had cirrhosis and all patients were on anti-viral therapy. 7 patients (35%) were undergoing HCC surveillance. PAGE-B scores stratified 5 patients (25%) as high risk, 10 (50%) as medium risk and 5 (25%) as low risk. [Table 1 and 2]

Conclusion
The majority of patients with CHB monoinfection are receiving HCC surveillance with annual US. Using the PAGE-B score we identified 40% that are low risk and for which regular surveillance may be deferred. Those who were stratified as medium or high risk would benefit from more frequent 6-monthly US. This audit highlights the benefit of risk stratification in the allocation of resources. There was a lack of surveillance in our coinfected population despite 15 patients (75%) being stratified as medium or high risk. This may be due to clinicians focusing on HIV-associated issues during clinic visits and highlights the importance of addressing both infections when reviewing these patients.

Disclosures
All Authors: No reported disclosures
2501. Trends in viral hepatitis and hepatocellular carcinoma in New York City, 2001–2018
Authors: Latham Ned H , Anger Holly , Bocour Angelica , Qiao Baozhen , Insaf Tabassum , McPherson Tristan D 
Published: November 2023

Abstract

Background
In New York City (NYC), an estimated 243,000 people live with chronic hepatitis B virus (HBV) infection and 86,000 people live with chronic hepatitis C virus (HCV) infection, representing 2.9% and 1% of the population, respectively. HBV and HCV can cause liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Early diagnosis improves HCC survival, and regular screening of people with HBV and other risk factors (e.g., family history of HCC or active liver inflammation) or HCV with cirrhosis is recommended. We aimed to describe recent trends in viral hepatitis and HCC in NYC.

Methods
We generated a retrospective cohort of NYC residents with HCC by matching New York State Cancer Registry data with NYC Health Department viral hepatitis surveillance data. We included all HCC cases diagnosed from 2001-2018 in the analyses, except those reported solely by Veterans Affairs hospitals or other state Cancer Registries. We defined people as having HBV and/or HCV if they met the Council for State and Territorial Epidemiologists’ probable or confirmed case definition before, or within 30 days of, their HCC diagnosis. We analyzed annual incidence of HCC stratified by viral hepatitis status (HBV, HCV, coinfection, neither), and the proportion of patients diagnosed with HCC at the local stage (vs. regional or distant stage).

Results
Between 2001–2018, 13,209 NYC residents were diagnosed with HCC; 2,456 (18.6%) had HBV, 5,379 (40.7%) had HCV, and 282 (2.1%) had HBV/HCV coinfection (Table 1). Incident HCC cases increased from 495 in 2001 to a peak of 878 cases in 2012 (Figure 1). The number of HCC cases with HBV or no viral hepatitis was relatively stable over the period, while HCC cases with HCV increased steadily until 2012, then declined slightly from 2016 to 2018. The proportion of HCC cases diagnosed at the local stage generally increased for people with HBV (48.3 to 60.7%), HCV (52.6% to 59.3%), and neither infection (41.4 to 57.6%).Figure 1.Trends in viral hepatitis status of incident hepatocellular carcinoma (HCC) cases among New York City residents, 2001–2018. HBV = hepatitis B virus HCV = hepatitis C virus HCC = hepatocellular carcinomaTable 1.Characteristics of people diagnosed with hepatocellular carcinoma with and without viral hepatitis in New York City, 2001–2018.IQR = interquartile range HCC = hepatocellular carcinoma Due to rounding, category percentages do not all sum to 100.

Conclusion
Recent declines in HCC among NYC residents reflect declines in HCC cases with HCV. Despite increases in the proportion of HCC cases diagnosed at the local stage, opportunities to improve screening remain. Additional analyses accounting for antiviral treatment, cirrhosis, alcohol intake, and mortality, would assist in further informing HCC prevention efforts.

Disclosures
All Authors: No reported disclosures
139. Clinical Predictors of a Positive MPox PCR: A Framework for Diagnostic Stewardship
Authors: Gonzales Adrienne M , Yeh Rose , Rostane ikram , Ratliff Hunter , Wanger Audrey , Ostrosky-Zeichner Luis 
Published: November 2023

Abstract

Background
In July 2022, an outbreak of MPox was reported in the United States as part of a world-wide health emergency. Healthcare settings in the US started to see possible cases, and the public health and clinical diagnostics infrastructure was quickly overwhelmed. As the concept of diagnostic stewardship is becoming increasingly more important, we sought to identify clinical information obtainable at presentation that would predict a positive MPox PCR in order to streamline testing and optimize resource utilization.
Table 1
RR and diagnostic performance for single and combined clinical factors resulting in a positive MPox PCR

Methods
The charts of 146 patients presenting for MPox testing in a large healthcare system in Texas in July and August 2022 were reviewed to identify clinical factors upon presentation that would correlate with a positive lesion PCR.

Results
49.3% of patients tested positive. The mean (SD) age of patients was 31.9 (8.41) years. The mean (SD) time of symptoms was 5.47 (5.08) days. The mean (SD) time from last sexual encounter was 17.6 (11.01) days. Table 1 shows the RR and diagnostic performance for each clinical factor resulting in a positive MPox PCR as well as the RR for those with 2, 3, and 4 combined high risk clinical factors.

Conclusion
Male gender, non-heterosexual sexual orientation, recent sexual encounter, painful lesions, contact with a known MPox case, systemic symptoms, and shorter symptom duration less than or equal to 6 days increased the risk of a positive Mpox PCR result and may be used to prioritize testing in a resource constrained environment. Patients presenting with a combination of 2, 3, and 4 risk factors further increased the likelihood of a positive test. Risk factors can be used for diagnostic stewardship in MPox testing. Further research will focus on creation and prospective validation of clinical prediction rules.

Disclosures
Luis Ostrosky-Zeichner, MD, FACP, FIDSA, FSHEA, FECMM, CMQ, Astellas: Grant/Research Support|Cidara: Advisor/Consultant|Cidara: Advisor/Consultant|F2G: Advisor/Consultant|Gilead: Advisor/Consultant|Gilead: Grant/Research Support|GSK: Advisor/Consultant|Melinta: Advisor/Consultant|NIH: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Pfizer: Honoraria|Pulmocide: Grant/Research Support|Scynexis: Grant/Research Support|T2 Biosystems: Grant/Research Support|Viracor: Advisor/Consultant
2503. Re-engagement in Care for Patients with Positive Hepatitis C Virus Antibody Test: A Descriptive Study at a Large University Hospital
Authors: Mendoza Denise , Ryan Keenan L , Deming Paulina , Cabos Heather , Bacon Kristin , Jakeman Bernadette 
Published: November 2023

Abstract

Background
An HCV micro-elimination project conducted at the University of New Mexico Hospital (UNMH) found a large number of patients with a positive HCV antibody test but no confirmatory HCV RNA test. The purpose of this study was to 1) conduct a telemedicine intervention to re-engage patients with a positive HCV antibody test and no confirmatory HCV RNA test and 2) investigate patient understanding of HCV testing and treatment and identify barriers that impeded patient access to care.

Methods
Through the hospital electronic medical record system, patients with positive HCV antibody tests were identified at UNMH in Albuquerque, NM, USA. Patients were eligible for study inclusion if they were aged &gt; 18 years and had a positive HCV antibody test with no confirmatory HCV RNA documented between January 2019-December 2020. Eligible patients were contacted by phone and asked to participate in a survey on questions addressing socio-demographics, patient awareness of HCV antibody results, knowledge of HCV, and knowledge of current oral HCV treatment options. At survey completion, patients were offered HCV confirmatory testing. Study investigators followed-up with patients who chose to obtain confirmatory testing to provide results and, if appropriate, to refer patients for HCV treatment. Data were analyzed using descriptive statistics to describe the study population. Re-engagement was measured based on the completion of the HCV RNA.

Methods
Inclusion/Exclusion Criteria

Results
Study investigators attempted to contact 454 patients. From the screened charts, 49% were not reached, 5% passed away, 6% declined, and 4% agreed to participate in the survey. The median age was 51 years. 60% were male and 55% were white. 82% had an annual income of &lt; $35k. All but one of the participants were aware of their HCV antibody test, but many were not aware of chronicity of the virus and available oral treatments. 15 patients had received outside follow up testing and/or treatment. 5 participants were successfully re-engaged in care and received confirmatory testing.
Screening Table
Patient Characteristics

Conclusion
This study highlights the complexity of reaching this patient population to re-engage patients in care for HCV, which is likely due to a number of previously identified socioeconomic factors. This further supports HCV programs that engage patients in care prior to hospital discharge.

Disclosures
Keenan L. Ryan, PharmD, PhC, PharmCon: Honoraria Paulina Deming, PharmD, Gilead: Advisor/Consultant
2507. Sex and race disparities in hepatocellular carcinoma surveillance in patients with chronic hepatitis B: a single center retrospective review
Authors: Reiche William , Cooper Stephen , Destache Christopher , Sidhu Suhail , Schutte Bryce , Keirns Darby , mac Elezabeth , Ng Ian , Buaisha Haitam , Velagapudi Manasa 
Published: November 2023

Abstract

Background
The management of patients with chronic hepatitis B (CHB) is complex and involves interdisciplinary care across multiple medical specialties. As a result of this complexity, patients with CHB often do not receive adequate monitoring including HCC surveillance with abdominal ultrasonography (AUS). Previous studies have identified multiple factors associated with decreased HCC surveillance. We aimed to study race and sex disparities in HCC surveillance in patients with CHB during the COVID-19 pandemic.

Methods
We performed a single center retrospective cohort study of patients treated for CHB between January 2018 and January 2022 in Gastroenterology and Infectious Diseases clinics at our institution. HCC surveillance trends for both sexes were further stratified by 6-month time intervals throughout the study period to compare surveillance during the COVID-19 surge at our region and after the surge. The COVID-19 pandemic surge was defined as time 1/1/2020-6/30/2021. Differences between sex and race were evaluated using the chi-square test, Fisher's exact test, and continuous variables were analyzed using analysis of variance (ANOVA).

Results
A total of 223 adult patient records between January 2018 and January 2022 were evaluated. In total 37% females were adequately screened for HCC in any of the 6-month time frames compared to 26% for males, p &gt;0.05. During the COVID-19 surge, surveillance rates were reduced in both males and females; however, men had significantly reduced HCC screening compared to women (men 38% compared to women 47%, P = 0.011, Figure 1). When comparing COVID-19 HCC screening, stratified by race, 20% Asians, 34% African Americans, and 22% Caucasians were screened by AUS, P = 0.069(Figure 2).
Patient Demographics
ID, infectious diseases clinic; GI, gastroenterology clinic; SD, standard deviation

Conclusion
Males received significantly less HCC surveillance compared to females. These differences continued during the COVID-19 pandemic surge. Obtaining appropriate surveillance is important and identifying disparities enables treating physicians to work on measures to mitigate them.

Disclosures
All Authors: No reported disclosures
2511. Screening for Hepatitis B Virus (HBV) and Tuberculosis (TB) Infection among Non-U.S.-Born Adults from High HBV and TB Burden Countries
Authors: Skarbinski Jacek , Ni Yuching , Wick Jenna M , Chitnis Amit S , Krueger Amy L , Jaganath Devan , Wong Robert J , Halmer Nicole 
Published: November 2023

Abstract

Background
Hepatitis B virus (HBV) infection and tuberculosis (TB) infection both disproportionately affect non-U.S.–born persons from countries with hepatitis B surface antigen (HBsAg) seroprevalence ≥2% or TB incidence rates ≥20/100,000 population. Early identification and treatment of chronic HBV and TB infection are critical to reduce morbidity and mortality, but little is known about HBV and TB screening among non-U.S.–born persons in the United States.

Methods
In a cross-sectional study using electronic health record data, we assessed HBV and TB infection screening practices among Kaiser Permanente Northern California eligible members aged ≥18 years born in countries with intermediate to high burdens of both HBV and TB infection. HBV screening was defined as testing for HBV surface antigen and HBV core antibody. TB infection screening was defined as testing with interferon gamma release assay or tuberculin skin test. We calculated the proportion of individuals from intermediate and high HBV-TB burden countries who had HBV or TB infection screening and the proportion of patients positive for HBV or TB infection.

Results
Of 498,339 non-U.S.–born adults, 275,708 (55.3%) were born in intermediate or high HBV-TB burden countries. Most patients were aged ≥50 years (65.3%) and 23.5% had diabetes. Among persons born in intermediate or high HBV-TB burden countries, 67.1% were screened for HBV infection, 29.4% were screened for TB infection, and only 23.7% were screened for both HBV and TB infection. Among all persons born in intermediate or high HBV-TB burden countries (both screened and unscreened), 3.7% had HBV infection and 10.1% had TB infection. Among 231,431 persons born in intermediate or high HBV-TB burden countries without current or prior HBV infection, 72.9% had received at least one HBV vaccine dose.

Conclusion
Among non-U.S.–born adults from intermediate or high HBV-TB burden countries, we found low screening proportions, intermediate prevalence of chronic HBV infection and high prevalence of TB infection. Given the large population of persons from intermediate or high HBV-TB burden countries in Kaiser Permanente Northern California, screening for both infections at the same time could improve early diagnosis and treatment for both conditions.

Disclosures
Jacek Skarbinski, MD, Genentech: Grant/Research Support|Gilead Sciences: Grant/Research Support Robert J. Wong, MD, MS, Gilead Sciences: Grant/Research Support
2512. A Decade in Review: An Analysis of the Qualified Infectious Disease Product (QIDP) Designation
Authors: Atillasoy Cem , Elmansy Lina , Gourlias Panagiotis 
Published: November 2023

Abstract

Background
The development of new antibiotics is a critical public health need, as antibiotic-resistant infections are responsible for tens of thousands of deaths each year in the U.S. In response, the QIDP (Qualified Infectious Disease Product) designation was established by the FDA under the Generating Antibiotic Incentives Now (GAIN) Act in 2012. The program incentivizes the development of new drugs to treat serious or life-threatening infections caused by bacteria or fungi that are resistant to existing treatments. These incentives include priority review and 5 additional years of market exclusivity for drugs that receive QIDP designation and are subsequently approved by the FDA.

Methods
We analyzed the FDA Database entitled, “Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals” for antimicrobial therapies approved after 2012. Antimicrobial therapies were defined as antibiotics and antifungals, excluding antivirals and antiparasitics which are ineligible for QIDP. We compared the status of the QIDP designation in drugs that gained FDA approval over two 5-year periods (2013-2017 vs. 2018-2022). We also analyzed the types of infections and pathogens targeted by these drugs.

Results
Since the GAIN Act in 2012, there have been 25 antimicrobial therapies approved, 20 with the QIDP designation (Table 1). 9 drugs with QIDP status were approved (out of 13 antimicrobials) from 2013-2017; whereas 2018-2022 had 11 drugs approved with QIDP status (out of 12 antimicrobials) (Figure 1). There was no significant difference in QIDP approvals over the two periods (69% vs. 92%, p=0.32).
Of the 20 drugs approved with the QIDP designation, 9 are indicated to treat genitourinary infections, 6 to treat gastrointestinal infections, 5 to treat skin infections, 3 to treat pulmonary infections and only 1 to treat systemic infections. Furthermore, 15 of the drugs targeted bacterial pathogens, 4 targeted fungal pathogens and 1 targeted mycobacteria (Table 2).

Conclusion
Our findings indicate that the QIDP designation has been moderately effective in generating renewed interest in the development of antibiotics. Additional strategies are needed to encourage continued infectious disease R&D efforts, especially around areas of unmet need such as systemic infection and fungal pathogens.

Disclosures
All Authors: No reported disclosures
2514. Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza
Authors: Flanagan Shawn , Ong Voon , Baguet Tristan , Rojas Roxana E , Wang Sy-Shi , Equils Ozlem 
Published: November 2023

Abstract

Background
CD388 is a novel antiviral drug-Fc conjugate (DFC) designed to deliver universal prevention of seasonal and pandemic influenza. Nonclinical studies have shown CD388 was effective prophylactically against a wide range of seasonal and pandemic influenza A and B strains in lethal and nonlethal mouse models of infection.

Methods
The design of the ongoing blinded CD388 First in Human study, which is being conducted in healthy subjects is shown in Figure 1. CD388 for injection (100 mg/mL) was administered by intramuscular (IM) or subcutaneous (SQ) routes of administration. Single dose pharmacokinetics were determined for subjects in the 50 and 150 mg cohorts of each dosing route at protocol specified nominal time points; alias subject numbers were used to maintain blind. Plasma CD388 concentrations were determined for subjects randomized to receive CD388 using a validated hybrid immunoassay LC-MS method with lower limit of quantitation (LLOQ) of 0.1 µg/mL.

Results
CD388 appeared to be well absorbed by IM or SQ routes of administration with maximum plasma concentrations (Tmax) appearing from 2 to 13 days post dose, and quantifiable concentrations ( &gt;LLOQ) lasting for several weeks to months (Figures 2 to 4). Mean apparent half-life of elimination was ∼ 50 days. Increases in CD388 exposures were approximately dose proportional for both routes (Figures 2 to 4).
No dose limiting local or systemic safety concerns were noted from review of ongoing blinded safety data and the study is proceeding at doses higher than those reported herein.

Conclusion
Plasma concentrations of CD388, were similar following intramuscular or subcutaneous routes of administration and were sustained. No safety concerns have been noted in this ongoing study.

Disclosures
Shawn Flanagan, PhD, Cidara Therapeutics: Salaried Employee|Cidara Therapeutics: Stocks/Bonds Voon Ong, Executive Director, Cidara Therapeutics: Stocks/Bonds Tristan Baguet, PharmD, Johnson & Johnson: Employee Roxana E. Rojas, M.D., Ph.D., Janssen: Employee|Janssen: Stocks/Bonds Sy-Shi Wang, Ph.D., Janssen Pharmaceutical: Employee Ozlem Equils, MD, Cidara Therapeutics: Employee|Cidara Therapeutics: Stocks/Bonds