6 results on '"Frament J"'
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2. Serial SARS-CoV-2 Antibody Titers in Vaccinated Dialysis Patients: Prevalence of Unrecognized Infection and Duration of Seroresponse.
- Author
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Hsu CM, Weiner DE, Manley HJ, Li NC, Miskulin D, Harford A, Sanders R, Ladik V, Frament J, Argyropoulos C, Abreo K, Chin A, Gladish R, Salman L, Johnson D, and Lacson EK Jr
- Abstract
Rationale & Objective: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are likely underdiagnosed, but the degree of underdiagnosis among patients receiving maintenance dialysis is unknown. The durability of the immune response after the third vaccine dose in this population also remains uncertain. This descriptive study tracked antibody levels to (1) assess the rate of undiagnosed infections and (2) characterize seroresponse durability after the third dose., Study Design: Retrospective observational study., Setting & Participants: SARS-CoV-2-vaccinated patients receiving maintenance dialysis through a national dialysis provider. Immunoglobulin G spike antibodies [anti-spike immunoglobulin (Ig) G] titers were assessed monthly after vaccination., Exposures: Two and 3 doses of SARS-CoV-2 vaccine., Outcomes: Undiagnosed and diagnosed SARS-CoV-2 infections; anti-spike IgG titers over time., Analytical Approach: Undiagnosed SARS-CoV-2 infections were identified as an increase in anti-spike IgG titer of ≥100 BAU/mL, not associated with receipt of vaccine or diagnosed SARS-CoV-2 infection (by polymerase chain reaction test or antigen test). In descriptive analyses, anti-spike IgG titers were followed over time., Results: Among 2,703 patients without previous coronavirus disease 2019 (COVID-19) who received an initial 2-dose vaccine series, 271 had diagnosed SARS-CoV-2 infections (3.4 per 10,000 patient-days) and 129 had undiagnosed SARS-CoV-2 infections (1.6 per 10,000 patient-days). Among 1,894 patients without previous COVID-19 who received a third vaccine dose, 316 had diagnosed SARS-CoV-2 infections (7.0 per 10,000 patient-days) and 173 had undiagnosed SARS-CoV-2 infections (3.8 per 10,000 patient-days). In both cohorts, anti-spike IgG levels declined over time. Of the initial 2-dose cohort, 66% had a titer of ≥500 BAU/mL in the first month, with 24% maintaining a titer of ≥500 BAU/mL at 6 months. Of the third dose cohort, 95% had a titer of ≥500 BAU/mL in the first month after the third dose, with 77% maintaining a titer of ≥500 BAU/mL at 6 months., Limitations: The assays used had upper limits., Conclusions: Among patients receiving maintenance dialysis, about 1 in every 3 SARS-CoV-2 infections was undiagnosed. Given this population's vulnerability to COVID-19, ongoing infection control measures are needed. A 3-dose primary mRNA vaccine series optimizes seroresponse rate and durability., Plain-Language Summary: Patients receiving maintenance dialysis have been particularly vulnerable to COVID-19. Using serially measured antibodies, we found that a substantial proportion (about one-third) of SARS-CoV-2 infections among this population had been missed, both among those who had completed a 2-dose vaccine series and among those who had received a third vaccine dose. Such missed infections likely had only mild or minimal symptoms, but this failure to recognize all infections is concerning. Furthermore, vaccines have been effective among patients receiving dialysis, but our study additionally shows that the immune response wanes over time, even after a third dose. There is therefore a role for ongoing vigilance against this highly transmissible infection., (© 2023 The Authors.)
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- 2023
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3. A real world comparison of HepB (Engerix-B®) and HepB-CpG (Heplisav-B®) vaccine seroprotection in patients receiving maintenance dialysis.
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Manley HJ, Aweh G, Frament J, Ladik V, and Lacson EK
- Subjects
- Humans, Retrospective Studies, Renal Dialysis, Hepatitis B Surface Antigens, Hepatitis B Antibodies, Hepatitis B Vaccines therapeutic use, Hepatitis B prevention & control
- Abstract
Background: Vaccination against hepatitis B virus (HBV) is recommended for dialysis patients. Two reports comparing seroprotection (SP) rates following HepB and HepB-CpG in vaccine-naïve patients with chronic kidney disease enrolled few dialysis patients (n = 122 combined). SP rates in a subset of dialysis patients were not reported or not powered to detect statistically significant differences. SP rates in those requiring additional vaccine series or booster doses are not known., Methods: A retrospective cohort analysis including dialysis patients completing HepB or HepB-CpG vaccination between January 2019 and December 2020. Vaccine-naïve patients received a series of HepB or HepB-CpG (Series 1). A repeat series was given to nonresponders (Series 2). A booster regimen consists of one dose of either vaccine. Primary outcome was achieving SP (anti-HBs >10 mIU/mL) at least 60 days after the last HBV vaccine dose for Series 1 and Series 2, and achieving SP at least 3 weeks post-booster., Results: For Series 1 (n = 3509), SP after HepB vaccination was significantly higher (62.9% versus 50.1% for HepB-CpG; P < 0.0001). Series 2 (n = 1040) and booster (n = 2028) SP rates were similar between vaccines. Patients that received up to four HepB-CpG doses had higher SP rates compared with four doses of HepB (82.0% versus 62.9%, respectively; P < 0.0001)., Conclusions: SP rates in hepatitis B vaccine-naïve dialysis patients administered a recommended four doses of HepB were higher than those recommended two doses of HepB-CpG. SP rates were higher and achieved sooner if HepB-CpG was utilized initially and, if needed, for Series 2. Optimal HepB-CpG dosing deserves further study., (© The Author(s) 2022. Published by Oxford University Press on behalf of the ERA.)
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- 2023
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4. Seroresponse to SARS-CoV-2 Vaccines among Maintenance Dialysis Patients over 6 Months.
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Hsu CM, Weiner DE, Manley HJ, Aweh GN, Ladik V, Frament J, Miskulin D, Argyropoulos C, Abreo K, Chin A, Gladish R, Salman L, Johnson D, and Lacson EK Jr
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- 2019-nCoV Vaccine mRNA-1273 administration & dosage, 2019-nCoV Vaccine mRNA-1273 immunology, Aged, Aged, 80 and over, BNT162 Vaccine administration & dosage, BNT162 Vaccine immunology, Biomarkers blood, COVID-19 immunology, COVID-19 virology, COVID-19 Vaccines immunology, Female, Humans, Immunocompromised Host, Male, Middle Aged, Renal Insufficiency, Chronic immunology, Retrospective Studies, Spike Glycoprotein, Coronavirus immunology, Time Factors, Treatment Outcome, United States, Vaccine Efficacy, Antibodies, Viral blood, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Immunogenicity, Vaccine, Immunoglobulin G blood, Renal Dialysis adverse effects, Renal Insufficiency, Chronic therapy, SARS-CoV-2 immunology, Vaccination
- Abstract
Background and Objectives: Although most patients receiving maintenance dialysis exhibit initial seroresponse to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, concerns exist regarding the durability of this antibody response. This study evaluated seroresponse over time., Design, Setting, Participants, & Measurements: This retrospective cohort study included patients on maintenance dialysis, from a midsize national dialysis provider, who received a complete SARS-CoV-2 vaccine series and had at least one antibody titer checked after full vaccination. IgG spike antibodies (anti-spike IgG) titers were assessed monthly with routine laboratory tests after vaccination; the semiquantitative assay reported a range between zero and ≥20 Index. Descriptive analyses compared trends over time by history of coronavirus disease 2019 (COVID-19) and vaccine type. Time-to-event analyses examined the outcome of loss of seroresponse (anti-spike IgG <1 Index or development of COVID-19). Cox regression adjusted for additional clinical characteristics., Results: Among 1870 patients receiving maintenance dialysis, 1569 had no prior COVID-19. Patients without prior COVID-19 had declining titers over time. Among 443 recipients of BNT162b2 (Pfizer), median (interquartile range) anti-spike IgG titer declined from ≥20 (5.89 to ≥20) in month 1 after full vaccination to 1.96 (0.60-5.88) by month 6. Among 778 recipients of mRNA-1273 (Moderna), anti-spike IgG titer declined from ≥20 (interquartile range, ≥20 to ≥20) in month 1 to 7.99 (2.61 to ≥20) by month 6. The 348 recipients of Ad26.COV2.S (Janssen) had a lower titer response than recipients of an mRNA vaccine over all time periods. In time-to-event analyses, recipients of Ad26.COV2.S and mRNA-1273 had the shortest and longest time to loss of seroresponse, respectively. The maximum titer reached in the first 2 months after full vaccination was associated with durability of the anti-spike IgG seroresponse; patients with anti-spike IgG titer 1-19.99 had a shorter time to loss of seroresponse compared with patients with anti-spike IgG titer ≥20 (hazard ratio, 15.5; 95% confidence interval, 11.7 to 20.7)., Conclusions: Among patients receiving maintenance dialysis, vaccine-induced seroresponse wanes over time across vaccine types. Early titers after full vaccination are associated with the durability of seroresponse., (Copyright © 2022 by the American Society of Nephrology.)
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- 2022
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5. Seroresponse to SARS-CoV-2 Vaccines Among Maintenance Dialysis Patients.
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Hsu CM, Weiner DE, Aweh GN, Manley HJ, Ladik V, Frament J, Miskulin D, Argyropoulos C, Abreo K, Chin A, Gladish R, Salman L, Johnson D, and Lacson EK
- Subjects
- Humans, Immunogenicity, Vaccine, Renal Dialysis, SARS-CoV-2, COVID-19, COVID-19 Vaccines
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- 2022
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6. Medication Reconciliation: The Foundation of Medication Safety for Patients Requiring Dialysis.
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Frament J, Hall RK, and Manley HJ
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- Aged, 80 and over, Humans, Male, Kidney Failure, Chronic therapy, Medication Errors prevention & control, Medication Reconciliation methods, Renal Dialysis methods
- Abstract
Medication-related problems are a leading cause of morbidity and mortality. Patients requiring dialysis are at heightened risk for adverse drug reactions because of the prevalence of polypharmacy, multiple chronic conditions, and altered (but not well understood) medication pharmacokinetics and pharmacodynamics inherent to kidney failure. To minimize preventable medication-related problems, health care providers need to prioritize medication safety for this population. The cornerstone of medication safety is medication reconciliation. We present a case highlighting adverse outcomes when medication reconciliation is insufficient at care transitions. We review available literature on the prevalence of medication discrepancies worldwide. We also explain effective medication reconciliation and the practical considerations for implementation of effective medication reconciliation in dialysis units. In light of the addition of medication reconciliation requirements to the Centers for Medicare & Medicaid Services End-Stage Renal Disease Quality Incentive Program, this review also provides guidance to dialysis unit leadership for improving current medication reconciliation practices. Prioritization of medication reconciliation has the potential to positively affect rates of medication-related problems, as well as medication adherence, health care costs, and quality of life., (Copyright © 2020 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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