Racial and ethnic minority groups and individuals with limited educational attainment experience a disproportionate burden of diabetes. Prediabetes represents a high-risk state for developing type 2 diabetes, but most adults with prediabetes are unaware of having the condition. Uncovering whether racial, ethnic, or educational disparities also occur in the prediabetes stage could help inform strategies to support health equity in preventing type 2 diabetes and its complications. We examined the prevalence of prediabetes and prediabetes awareness, with corresponding prevalence ratios according to race, ethnicity, and educational attainment. This study was a pooled cross-sectional analysis of the National Health and Nutrition Examination Survey data from 2011 to March 2020. The final sample comprised 10,262 U.S. adults who self-reported being Asian, Black, Hispanic, or White. Prediabetes was defined using hemoglobin A1c and fasting plasma glucose values. Those with prediabetes were classified as "aware" or "unaware" based on survey responses. We calculated prevalence ratios (PR) to assess the relationship between race, ethnicity, and educational attainment with prediabetes and prediabetes awareness, controlling for sociodemographic, health and healthcare-related, and clinical characteristics. In fully adjusted logistic regression models, Asian, Black, and Hispanic adults had a statistically significant higher risk of prediabetes than White adults (PR:1.26 [1.18,1.35], PR:1.17 [1.08,1.25], and PR:1.10 [1.02,1.19], respectively). Adults completing less than high school and high school had a significantly higher risk of prediabetes compared to those with a college degree (PR:1.14 [1.02,1.26] and PR:1.12 [1.01,1.23], respectively). We also found that Black and Hispanic adults had higher rates of prediabetes awareness in the fully adjusted model than White adults (PR:1.27 [1.07,1.50] and PR:1.33 [1.02,1.72], respectively). The rates of prediabetes awareness were consistently lower among those with less than a high school education relative to individuals who completed college (fully-adjusted model PR:0.66 [0.47,0.92]). Disparities in prediabetes among racial and ethnic minority groups and adults with low educational attainment suggest challenges and opportunities for promoting health equity in high-risk groups and expanding awareness of prediabetes in the United States.

Abstract Background Cytomegalovirus (CMV) is a latent virus that can cause morbidity and mortality among immunocompromised (IC) individuals. No studies have examined how CMV testing changed throughout the COVID-19 pandemic among IC individuals in the United States (US). This study aimed to estimate CMV testing rates among IC adults (18-94 years), adolescents (12-17 years), and children (0-11 years) during the COVID-19 pandemic. Methods This observational cohort study included insured individuals from the US and was conducted using administrative medical and pharmacy claims from HealthVerity from December 2017-May 2022. IC adults, adolescents, and children entered the cohort after 6 months of continuous enrollment and were followed until disenrollment or end of study period. CMV testing was captured using CPT codes (serology and PCR) and was limited to no more than 1 test per day with ≥6 days required between tests. The rate of CMV testing (per 100,000 person-months) was estimated over three time periods defined by key points in the COVID-19 pandemic: pre-COVID-19-era, 06/01/2018-03/31/2020; pre-vaccine-COVID-19-era, 04/01/2020-12/31/2020; and vaccine-COVID-19-era, 01/01/2021-05/31/2022. Results The sample included 735,251 IC adults, of whom 4.8% (N=35,391) had ≥1 CMV test over follow-up (median follow-up, 566 days); 12,203 IC adolescents, of whom 15.5% (N=1,896) had ≥1 CMV test over follow-up (median follow-up, 582 days); and 15,854 IC children, of whom 14.7% (N=2,324) had ≥1 CMV test over follow-up (median follow-up, 702 days). The mean rate of CMV tests per 100,000 person-months for IC adults was 1,660 in the pre-COVID-19-era, 1,040 in the pre-vaccine-COVID-19-era, and 983 in the vaccine-COVID-19-era. Similarly, rates of CMV testing declined among IC adolescents and children (adolescents: 7,391 in pre-COVID-19-era, 4,717 in pre-vaccine-COVID-19-era, and 4,219 in vaccine-COVID-19-era; children: 7,556 in pre-COVID-19-era, 4,467 in pre-vaccine-COVID-19-era, and 4,026 in vaccine-COVID-19-era). The highest testing rates were among those with a history of stem cell transplantation in all age cohorts. Conclusion CMV test utilization decreased during the COVID-19 pandemic era in the US and remained low through the early COVID-19 vaccine era. Disclosures Sandeep Basnet, MD, Moderna Therapeutics: Stocks/Bonds Brent Arakaki, BS, Aetion, Inc.: Employee Katherine E. Mues, PhD, Aetion, Inc.: Employee John D. Diaz-Decaro, PhD, MS, Moderna Therapeutics: Stocks/Bonds

Abstract Background With the development of combined influenza and COVID-19 vaccines, there is a need to understand contemporary patterns of both COVID-19 and influenza vaccine administration in the real world. This study aimed to describe patterns and assess predictors of COVID-19 and influenza vaccine administration among insured, influenza-vaccinated adults in the US from 2020 to 2022.Figure 1.Study SchemaFigure 2.Multivariable Odds Ratios for Factors Associated With Observed Vaccine Pattern in Follow-up Methods A cohort of adults ≥18 years with evidence of an influenza vaccination administered between August 1, 2020, and July 31, 2021 (index date) was generated using open and closed administrative claims sourced from HealthVerity. Fig 1 includes additional inclusion and exclusion criteria, subject characteristics, and follow-up windows. Baseline characteristics and time-to-subsequent vaccine administration after index date were assessed via descriptive statistics. Multinomial logistic regression was used to assess the association between subject characteristics and receipt of subsequent influenza and COVID-19 vaccines. Results Of 3,043,095 influenza vaccinated adults, 13.7% had a subsequent influenza vaccination, 21.1% had a subsequent COVID-19 vaccination, and 50.7% had both through July 31, 2022. Following the index date, the median (IQR) time to a subsequent influenza vaccine was 373 (353, 396) days and 185 (144, 383) days for a subsequent COVID-19 vaccine. Among those who received both vaccines, most (64.1%) received a COVID-19 vaccine followed by influenza. Prior influenza vaccine was associated with subsequent receipt of both vaccines vs influenza only (OR, 95% CI: 1.18, 1.18-1.19). Adults ≥65 years and those considered high-risk for serious complications were slightly less likely to receive both vaccines compared to influenza only (Fig 2; OR, 95% CI, ≥65 years: 0.93, 0.92-0.94; high-risk: 0.91, 0.90-0.92). Outcome misclassification could be driving these results. Conclusion During influenza seasons impacted by the COVID-19 pandemic, evidence of prior preventive services and immunizations were associated with subsequent influenza and COVID-19 vaccine administration. As the pandemic subsides, there will be a continued need to assess COVID-19 and influenza vaccination patterns to inform future vaccination campaigns, including combination influenza and COVID-19 vaccines. Disclosures Christopher Bush, MPH, Aetion, Inc.: Employee|Aetion, Inc.: Stocks/Bonds Katherine E. Mues, PhD, Aetion, Inc.: Employee Shaina Desai, MPH, Aetion, Inc.: Employee Brent Arakaki, BS, Aetion, Inc.: Employee Priyadarshani Dharia, PhD, MD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Parinaz Ghaswalla, PhD, Moderna, Inc: Employee|Moderna, Inc: Stocks/Bonds Yoonyoung Park, ScD, Moderna, Inc.: Employee|Moderna, Inc.: Stocks/Bonds

Abstract Background Herpes simplex virus type-2 (HSV-2) is the most frequent cause of genital herpes (GH) in the United States (US). There is no cure for HSV-2, but antiviral drugs can reduce outbreaks. Limited epidemiologic data exist on the contemporary burden of GH and treatment. The objective of this study was to estimate the annual GH prevalence and antiviral treatment rates. Methods This observational study utilized cohorts to calculate annual period prevalence rates of GH and included US administrative claims data from HealthVerity medical and pharmacy claims of continuously enrolled insured individuals. The crude and age-sex standardized prevalence rates of GH and recurrent GH were calculated from 01/01/2019 to 12/31/2021, by calendar year. GH was defined as >1 ICD-10 diagnosis code. Recurrent GH was defined as >2 GH diagnosis codes, at least 28 days apart, or >1 GH diagnosis code followed by at least 2 non-overlapping antiviral drug claims. Among those with GH, the proportion of patients untreated or on episodic or suppressive antiviral treatment was estimated. Episodic treatment was defined as <6 months of antiviral treatment, and suppressive treatment was defined >6 months of antiviral treatment, within each calendar year. Analyses were stratified by age, sex, and immunocompromised status. Results From 2019 to 2021, the age-sex standardized prevalence rates of GH ranged from 236 to 280 per 100,000 person-years (py) and from 81 to 98 per 100,000 py for recurrent GH. The prevalence rates of GH and recurrent GH were highest among females, those 25-29 years of age, and in immunocompromised individuals. Approximately one-third of patients with GH were untreated (32%-35%) in a given year. Among those treated for GH, the majority received episodic antiviral treatment (80%) rather than suppressive treatment (20%). Conclusion GH prevalence rates were 236 to 280 per 100,000 py and recurrent GH was one-third of this. GH and recurrent GH were more common in females, young adults, and immunocompromised individuals. Approximately two-thirds of GH patients were treated with antivirals, and the majority of these received episodic treatment. Disclosures Emma Viscidi, PhD, MHS, Moderna: Employee|Moderna: Stocks/Bonds Alan Embry, PhD, Moderna Therapeutics: Stocks/Bonds Brent Arakaki, BS, Aetion, Inc.: Employee

Abstract Background An estimated one in three adults in the United States (US) will develop Herpes zoster (HZ) during their lifetime, with substantially increased risk after age 50. Approximately 15% of individuals with HZ develop postherpetic neuralgia (PHN). HZ is vaccine-preventable, and vaccination is currently recommended for those 50 years of age and older, as well as individuals 19 years of age and older with weakened immune systems. Contemporary data on HZ vaccination, and the burden of HZ and PHN in US adults, is needed. Methods This observational cohort study was conducted using administrative medical and pharmacy claims data from HealthVerity and included insured individuals (commercial, Medicare Advantage, or Medicaid plans) across the US. Among patients with continuous enrollment from 01/01/2019 to 05/31/2022, the distribution of patients with 1 and 2 doses of Shingrix (Recombinant zoster vaccine) was estimated. Crude and US age-sex standardized incidence rates of HZ and PHN were calculated from 01/01/2019 to 12/31/2021, by calendar year, in persons >19 years. HZ was defined as >1 ICD-10 diagnosis code for HZ. PHN was defined as >1 ICD-10 diagnosis code for PHN. Analyses were stratified by age, sex, and immunocompromised status. Results Among those >50 years (N=25,286,865), 4.3% (N=1,087,066) received 1 dose and 9.0% (N=2,273,827) received 2 doses of Shingrix anytime from 01/01/2019 to 05/31/2022. The standardized annual incidence rates of HZ from 2019-2021 ranged from 542 to 685 per 100,000 person-years (py) and from 35 to 38 per 100,000 py for PHN. The incidence rates of HZ and PHN were higher among females, older adults, and immunocompromised individuals. Conclusion In this analysis in a US claims database, 9% of persons aged 50+ years received 2 doses of the Shingrix vaccine. Herpes zoster and PHN were more frequent among older adults, females, and immunocompromised individuals. This study provides contemporary, representative estimates of the incidence of herpes zoster and PHN, as well as the frequency of herpes zoster vaccination, which is important information on disease burden in the US. Disclosures Alan Embry, PhD, Moderna Therapeutics: Stocks/Bonds Brent Arakaki, BS, Aetion, Inc.: Employee Emma Viscidi, PhD, MHS, Moderna: Employee|Moderna: Stocks/Bonds

This cohort study investigates rates of cytomegalovirus testing before and during the COVID-19 pandemic among individuals who were immunocompromised.

Adherence to imatinib in chronic myeloid leukemia (CML) patients is estimated to be as low as 70% despite its clinical benefit, and our understanding of the impact of nonadherence in this population is limited. This study presents a novel application of the Alternating Conditional Estimation (ACE) algorithm in newly diagnosed CML patients to map the full dose-response curve (DRC) and determine how the strength of this curve varies over time. We applied the ACE algorithm alongside a backward elimination procedure to detect the presence of time dependence and nonlinearity in the relationship between imatinib adherence and time-to-remission. An extended Cox model allowing for the flexible modeling of identified effects via unpenalized B-splines was subsequently fit and assessed. The substantial improvement in model fit associated with the extended Cox approach suggests that traditional Cox proportional hazards model assumptions do not hold in this setting. Results indicate that the DRC for imatinib is non-linearly increasing, with an attenuated effect above a 74% adherence rate. The strength of this effect on remission varied over time and was strongest in the initial months of treatment, reaching a peak around 90 days post-initiation (log hazard ratio: 2.12, 95% confidence interval: 1.47 to 2.66). Most patients that achieved remission did so by 4 months (120 days) with consistently high adherence, suggesting that this could be a critical time and duration for realizing treatment benefit and patient monitoring. Findings regarding the relationship between adherence and remission can additionally help guide the design of future studies.

AbstractIntroductionTo compare the real-world effectiveness of a third dose of mRNA-1273 versus a third dose of BNT162b2 against breakthrough COVID-19 hospitalizations among adults age ≥65 years who completed a primary series of an mRNA-based COVID-19 vaccine (regardless of which primary series was received).Materials and methodsThis observational comparative vaccine effectiveness (VE) study was conducted using administrative claims data from the US HealthVerity database (September 22, 2021, to August 31, 2022). A third dose of mRNA-1273 versus BNT162b2 was assessed for preventing COVID-19 hospitalizations and medically attended COVID-19 among adults ≥65 years. Inverse probability of treatment weighting was applied to balance baseline characteristics between vaccine groups. Incidence rates from patient-level data and hazard ratios (HRs) with 95% confidence intervals (CIs) using weighted Cox proportional hazards models were calculated to estimate relative VE for each outcome.ResultsOverall, 94,587 and 92,377 individuals received a third dose of mRNA-1273 and BNT162b2, respectively. Among the weighted population, the median age was 69 years (interquartile range, 66-74), 53% were female, and 46% were commercially insured. COVID-19 hospitalization rates per 1000 person-years (PYs) were 5.61 (95% CI, 5.13-6.09) for mRNA-1273 and 7.06 (95% CI, 6.54-7.57) for BNT162b2 (HR, 0.82; 0.69-0.98). Medically attended COVID-19 rates per 1000 PYs (95% CI) were 95.05 (95% CI, 93.03-97.06) for mRNA-1273 and 106.55 (95% CI, 104.53-108.57) for BNT162b2 (HR, 0.93; 0.89-0.98).ConclusionsResults from this observational comparative VE database study provide evidence that among older adults, a third dose of mRNA-1273 was more effective in preventing breakthrough COVID-19 hospitalization and medically attended COVID-19 infection compared with a third dose of BNT162b2.

To estimate the incidence rates (IR) of prespecified outcomes of interest in pediatric patients (1month to < 1year) treated with intravenous (IV) pantoprazole using Optum's longitudinal electronic health records database (Optum Market Clarity) from the United States (US). This real-world, non-interventional, retrospective cohort study was conducted from 01 January 2007 to 31 December 2020 in patients who received IV pantoprazole. Premature patients and those weighing < 2.36kg were excluded. Patients were categorized based on diagnosis of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) into: Subgroup 1 (GERD and EE), Subgroup 2 (GERD and no EE), and Subgroup 3 (absence of GERD and EE). Overall IRs (per 1000 person-years [PY]) and 95% confidence intervals (CI) of outcomes were estimated (overall and subgroups) and stratified by duration of IV pantoprazole treatment (< 4days versus ≥ 4days). Of 1879 eligible patients, none were identified in Subgroup 1; 851 (45.3%) and 1028 (54.7%) patients were identified in Subgroups 2 and 3, respectively. IRs of outcomes of interest ranged from 0.0 to 742.8 per 1000 PY. IRs were highest for vomiting (742.80), diarrhea (377.77), abdominal distension (214.31), hyponatremia (204.99), and hypokalemia (203.49). IRs were comparable between Subgroups 2 and 3. For most outcomes, IRs were higher among patients treated with IV pantoprazole for ≥ 4days versus those treated for < 4days. These results are consistent with the known safety profile of pantoprazole and emphasize the utility of using real-world data from pediatric populations for assessment of safety outcomes.