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Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019). 欧洲异黄酮唑实际使用的有效性、安全性和模式(2015-2019 年)。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-24 DOI: 10.1007/s40121-024-01064-4
Dionysios Neofytos, Antonio Pagliuca, Katherine Houghton, Edward Broughton, Maria Lavinea Novis de Figueiredo Valente, Lili Jiang, David A Enoch, Beate Gruener, Raoul Herbrecht, Tobias Lahmer, Olivier Lortholary, Cléa Melenotte, Francesco Giuseppe De Rosa, Carolina Garcia-Vidal, Maria Jimenez, Maria Fernandez, Oliver Cornely
{"title":"Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019).","authors":"Dionysios Neofytos, Antonio Pagliuca, Katherine Houghton, Edward Broughton, Maria Lavinea Novis de Figueiredo Valente, Lili Jiang, David A Enoch, Beate Gruener, Raoul Herbrecht, Tobias Lahmer, Olivier Lortholary, Cléa Melenotte, Francesco Giuseppe De Rosa, Carolina Garcia-Vidal, Maria Jimenez, Maria Fernandez, Oliver Cornely","doi":"10.1007/s40121-024-01064-4","DOIUrl":"https://doi.org/10.1007/s40121-024-01064-4","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world data from multinational observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe.</p><p><strong>Methods: </strong>A retrospective medical record review was conducted at 16 sites in Europe (France, Germany, Italy, Spain, and the United Kingdom). Eligible records were from patients aged ≥ 18 years at the time of isavuconazole initiation and received at least one dose of isavuconazole for suspected or confirmed invasive aspergillosis (IA) or invasive mucormycosis (IM) during the eligibility period (October 15, 2015 to June 30, 2019). Data were descriptively analysed. Success rates, overall survival, and times to these events were descriptively analysed.</p><p><strong>Results: </strong>Data were abstracted from 218 patients (201, IA; 17, IM) who received isavuconazole as monotherapy (initiated as infusion, 52%; oral, 46%). Isavuconazole was initiated as primary therapy in 92 patients (42.2%) and salvage therapy in 121 patients (55.5%) (unknown for five patients). Mean (standard deviation) age was 56.8 (15.6) years, 66% were men and 62% had at least three comorbidities, most frequently haematologic malignancy (62%). Estimated clinical response rate at week 24 was 54.5% (95% confidence interval [CI], 38.2-66.5%) for primary treatment and 73.5% (95% CI, 62.7-81.1%) for salvage therapy. Overall, 45 patients (21%) experienced at least one adverse event (AE). Serious AEs were experienced by 37 patients (17%), with seven related to isavuconazole; five patients (2.3%) discontinued isavuconazole monotherapy due to the serious AE. A total of 137 patients (63%) died, with 17 deaths (12.4%) related to their invasive fungal infection, 11 of whom initiated isavuconazole as salvage therapy.</p><p><strong>Conclusions: </strong>This study adds to the growing body of evidence that whether used as first-line therapy or after the failure of other antifungal therapies, isavuconazole appears to have a promising clinical response and a good safety profile as an antifungal agent in patients with varied underlying conditions.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Omadacycline for Diverse Infections in China: A Real-World Analysis of Efficacy and Safety. 奥马他环素在中国治疗多种感染:疗效与安全性的真实世界分析》。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-22 DOI: 10.1007/s40121-024-01065-3
Weiwen Gao, Jian Yang, Xiangwang Zhang, Lei Tian, Dong Xu, Shuyun Xu, Dong Liu, Yan He
{"title":"Omadacycline for Diverse Infections in China: A Real-World Analysis of Efficacy and Safety.","authors":"Weiwen Gao, Jian Yang, Xiangwang Zhang, Lei Tian, Dong Xu, Shuyun Xu, Dong Liu, Yan He","doi":"10.1007/s40121-024-01065-3","DOIUrl":"https://doi.org/10.1007/s40121-024-01065-3","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy and safety of omadacycline have been primarily documented through Phase III clinical trials; however, there are limited data from real-world clinical settings. This study aims to explore the real-world use of omadacycline in China and identify the factors associated with its efficacy.</p><p><strong>Methods: </strong>We conducted a retrospective review of medical records for patients treated with omadacycline at a single center from March 2022 to March 2024. We analyzed demographic characteristics, laboratory results, antibiotic regimens, and clinical outcomes. Logistic regression was employed to identify risk factors associated with clinical treatment failure or failure of microbial clearance.</p><p><strong>Results: </strong>A total of 183 patients were included in the final analysis. Clinical success was achieved in 71.0% (130/183) of patients, with a bacterial clearance rate of 61.9% (26/42). Renal impairment was observed in 20.8% (38/183) of patients, with 39.5% (15/38) of these patients receiving nephrotoxic antibiotic treatments. Noteworthy adverse drug reactions were rare during the course of the treatment. Multivariate logistic regression analysis identified several independent factors associated with treatment failure: moderate to severe liver damage (OR: 3.073, 95% CI 1.345-7.021, p = 0.008), admission to the respiratory department (OR: 2.573, 95% CI 1.135-5.834, p = 0.024), and a duration of omadacycline therapy of less than 7 days (OR: 3.762, 95% CI 1.626-8.706, p = 0.002).</p><p><strong>Conclusions: </strong>Our study demonstrates that omadacycline treatment can achieve favorable clinical success and bacterial clearance, with positive safety and tolerability outcomes. However, high-quality randomized controlled trials are needed to validate these initial findings.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expanding Treatment Opportunities: Reviewing the Current State of Injectable Antiretrovirals for Treatment of HIV. 扩大治疗机会:回顾注射用抗逆转录病毒药物治疗艾滋病的现状。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-17 DOI: 10.1007/s40121-024-01062-6
Amanda Binkley, Matty Zimmerman, Christina Maguire
{"title":"Expanding Treatment Opportunities: Reviewing the Current State of Injectable Antiretrovirals for Treatment of HIV.","authors":"Amanda Binkley, Matty Zimmerman, Christina Maguire","doi":"10.1007/s40121-024-01062-6","DOIUrl":"https://doi.org/10.1007/s40121-024-01062-6","url":null,"abstract":"<p><p>Antiretroviral therapy has evolved significantly over the last 20-30 years, from requiring multiple tablets multiple times per day to single-tablet regimens and most recently, in 2021, long-acting injectable antiretrovirals. These long-acting antiretrovirals have expanded the treatment options for individuals with HIV who may have difficulty adhering to daily oral medications, difficulty taking oral medications, and/or individuals with multidrug-resistant HIV. This article reviews the currently available long-acting injectable antiretrovirals, including cabotegravir/rilpivirine, lenacapavir, and ibalizumab. The available data supporting these agents and current place in therapy will be discussed. Data supporting the use of additional long-acting injectable agents, broadly neutralizing antibodies, currently in the pipeline will be reviewed as well.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. 复发性 CDI 微生物组疗法 3 期试验的安全性和有效性综合分析。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-01 Epub Date: 2024-06-28 DOI: 10.1007/s40121-024-01007-z
Colleen S Kraft, Matthew Sims, Michael Silverman, Thomas J Louie, Paul Feuerstadt, Edward S Huang, Sahil Khanna, Charles S Berenson, Elaine E L Wang, Stuart H Cohen, Louis Korman, Christine Lee, Colleen R Kelly, Alberto Odio, Paul P Cook, Bret Lashner, Mayur Ramesh, Princy Kumar, Ananya De, Asli Memisoglu, David A Lombardi, Brooke R Hasson, Barbara H McGovern, Lisa von Moltke, Darrell S Pardi
{"title":"Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.","authors":"Colleen S Kraft, Matthew Sims, Michael Silverman, Thomas J Louie, Paul Feuerstadt, Edward S Huang, Sahil Khanna, Charles S Berenson, Elaine E L Wang, Stuart H Cohen, Louis Korman, Christine Lee, Colleen R Kelly, Alberto Odio, Paul P Cook, Bret Lashner, Mayur Ramesh, Princy Kumar, Ananya De, Asli Memisoglu, David A Lombardi, Brooke R Hasson, Barbara H McGovern, Lisa von Moltke, Darrell S Pardi","doi":"10.1007/s40121-024-01007-z","DOIUrl":"10.1007/s40121-024-01007-z","url":null,"abstract":"<p><strong>Introduction: </strong>Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI.</p><p><strong>Objective, design, and patients: </strong>To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities.</p><p><strong>Methods: </strong>VOS or placebo [ECOSPOR III only] (4 capsules once daily for 3 days). Integrated analysis of treatment-emergent adverse events (TEAEs) collected through week 8; serious TEAEs and TEAEs of special interest collected through week 24; and rates of rCDI (toxin-positive diarrhea requiring treatment) evaluated through weeks 8 and 24.</p><p><strong>Results: </strong>TEAEs were mostly mild or moderate and gastrointestinal. Most common treatment-related TEAEs were flatulence, abdominal pain and distension, fatigue, and diarrhea. There were 11 deaths (3.2%) and 48 patients (13.8%) with serious TEAEs, none treatment-related. The rCDI rate through week 8 was 9.5% (95% CI 6.6-13.0) and remained low through 24 weeks (15.2%; 95% CI 11.6-19.4). Safety and rCDI rates were consistent across subgroups including age, renal impairment/failure, diabetes, and immunocompromise/immunosuppression.</p><p><strong>Conclusions: </strong>VOS was well tolerated and rates of rCDI remained low through week 24 including in those with comorbidities. These data support the potential benefit of VOS following antibiotics to prevent recurrence in high-risk patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03183128 and NCT03183141.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11416444/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Letter to the Editor Regarding 'Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines Among Older Adults: Systematic Literature Review and Meta-analysis Using the GRADE Framework'. 致编辑的一封信:"mRNA-1273 和 BNT162b2 COVID-19 疫苗在老年人中的效果比较:使用 GRADE 框架的系统性文献综述和元分析"。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-24 DOI: 10.1007/s40121-024-01019-9
Hannah R Volkman, Jennifer L Nguyen, Luis Jodar, John M McLaughlin
{"title":"A Letter to the Editor Regarding 'Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines Among Older Adults: Systematic Literature Review and Meta-analysis Using the GRADE Framework'.","authors":"Hannah R Volkman, Jennifer L Nguyen, Luis Jodar, John M McLaughlin","doi":"10.1007/s40121-024-01019-9","DOIUrl":"10.1007/s40121-024-01019-9","url":null,"abstract":"","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11416434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19. 小剂量、快速输注巴马单抗和依替西单抗的有效性和安全性:轻度至中度 COVID-19 的 3 期 BLAZE-1 试验。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-04 DOI: 10.1007/s40121-024-01031-z
Dipak R Patel, Lisa Macpherson, Martin Bohm, Himanshu Upadhyaya, Carmen Deveau, Ajay Nirula, Paul Klekotka, Mark Williams, Matthew M Hufford
{"title":"Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19.","authors":"Dipak R Patel, Lisa Macpherson, Martin Bohm, Himanshu Upadhyaya, Carmen Deveau, Ajay Nirula, Paul Klekotka, Mark Williams, Matthew M Hufford","doi":"10.1007/s40121-024-01031-z","DOIUrl":"10.1007/s40121-024-01031-z","url":null,"abstract":"<p><strong>Introduction: </strong>The monoclonal antibody therapies bamlanivimab (BAM) + etesevimab (ETE) received emergency use authorization (EUA) from the US Food and Drug Administration (February 9, 2021) for treatment of mild-to-moderate COVID-19. The EUA of BAM + ETE was revoked (December 14, 2023) due to the high prevalence of BAM + ETE-resistant variants of SARS-CoV-2. Efficacy and safety of 700/1400 mg and 2800/2800 mg BAM + ETE are well established and published; however, efficacy and safety of 350/700 mg BAM + ETE have not been disclosed to date.</p><p><strong>Methods: </strong>This portion of phase 3, BLAZE-1 trial (J2X-MC-PYAB) enrolled patients (between June 17, 2020 and April 9, 2021) with mild-to-moderate COVID-19 within 3 days of laboratory diagnosis of SARS-CoV-2 infection. In total, 354 patients with at least one risk factor for severe COVID-19 were enrolled, randomized (2:3), and infused with placebo (N = 141) or 350/700 mg BAM + ETE (N = 213), over ~ 8 min. Primary endpoint was to assess proportion of patients with persistently high SARS-CoV-2 viral load (PHVL) (log viral load > 5.27) 7 days after infusion.</p><p><strong>Results: </strong>Patients were aged (mean) 53 years, 49.7% female, and 82.7% White. Seven days after drug infusion, 10.8% (95% confidence interval: 6.6, 15.0; p < 0.001) of BAM + ETE-treated patients and 34.8% (26.9, 42.6) of placebo-treated patients had PHVL, and the viral load change from baseline (least square mean [standard error]) was - 3.50 (0.15; p < 0.001) in BAM + ETE-treated patients versus - 2.51 (0.19) in placebo-treated patients. The majority of treatment-emergent adverse events were considered mild or moderate in severity (BAM + ETE: 6.6%; placebo: 14.2%). No deaths were reported.</p><p><strong>Conclusions: </strong>Consistent with previous studies, patients treated with BAM + ETE (350/700 mg) had a significantly lower proportion of PHVL and greater reduction in viral load compared with placebo. The overall safety profile is consistent with higher doses of BAM + ETE. Infusions of over ~ 8 min did not result in meaningful increase in incidence of TEAEs compared to higher doses of BAM + ETE administered over 30-60 min.</p><p><strong>Trial registration: </strong>Clinical trial.gov identifier, NCT04427501.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11416433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mycoplasma hominis as Cause of Extragenital Infection in Patients with Hypogammaglobulinemia: Report of 2 Cases and Literature Review. 人型支原体是低丙种球蛋白血症患者生殖器外感染的病因:2例病例报告及文献综述。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-04 DOI: 10.1007/s40121-024-01035-9
Chiara Russo, Malgorzata Mikulska, Emanuele Delfino, Federica Toscanini, Laura Mezzogori, Riccardo Schiavoni, Claudia Bartalucci, Emanuele Angelucci, Giulia Bartalucci, Massimiliano Gambella, Anna Maria Raiola, Paola Morici, Francesca Crea, Silvia Chiola, Silvia Daniela Morbelli, Anna Marchese, Matteo Bassetti
{"title":"Mycoplasma hominis as Cause of Extragenital Infection in Patients with Hypogammaglobulinemia: Report of 2 Cases and Literature Review.","authors":"Chiara Russo, Malgorzata Mikulska, Emanuele Delfino, Federica Toscanini, Laura Mezzogori, Riccardo Schiavoni, Claudia Bartalucci, Emanuele Angelucci, Giulia Bartalucci, Massimiliano Gambella, Anna Maria Raiola, Paola Morici, Francesca Crea, Silvia Chiola, Silvia Daniela Morbelli, Anna Marchese, Matteo Bassetti","doi":"10.1007/s40121-024-01035-9","DOIUrl":"10.1007/s40121-024-01035-9","url":null,"abstract":"<p><p>Mycoplasma hominis can be a part of human urogenital tract microbiome, and it is a frequent cause of urogenital infections. In rare cases, it can also cause extragenital infections, especially in immunocompromised patients. In this case series, we report two cases and provide a literature review of extragenital infections caused by M. hominis in patients with hypogammaglobulinemia. Patient 1 was a 61-year-old woman with diffuse large B-cell lymphoma who, after rituximab-containing chemotherapy and CAR-T therapy, developed M. hominis spondylodiscitis. Patient 2 was a 50-year-old woman with congenital hypogammaglobulinemia who developed disseminated M. hominis infection involving pleura, muscles, and right ankle. Antibiotic therapy with levofloxacin and doxycycline for 10 weeks in patient 1 and with levofloxacin alone for 6 weeks in patient 2 led to infection resolution. The literature review identified 14 additional cases reporting M. hominis extragenital infection in patients with hypogammaglobulinemia. M. hominis should also be suspected as an etiological agent of extragenital infection in patients with B-cell immunodeficiency with a clinical picture of persistent, standard-culture negative infection, particularly with arthritis or abscess formation. Even if M. hominis can grow on standard bacterial medium, in suspected cases molecular methods should be promptly used for correct diagnostic work-up and successful therapy.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11416451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Disease Burden Associated with All Infants in Their First RSV Season in the UK: A Static Model of Universal Immunization with Nirsevimab Against RSV-Related Outcomes. 英国所有婴儿在第一个 RSV 季节的疾病负担:针对 RSV 相关结果的 Nirsevimab 普遍免疫静态模型。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-05 DOI: 10.1007/s40121-024-01037-7
Alexia Kieffer, Matthieu Beuvelet, Gerald Moncayo, Mersha Chetty, Aditya Sardesai, Robert Musci, Richard Hudson
{"title":"Disease Burden Associated with All Infants in Their First RSV Season in the UK: A Static Model of Universal Immunization with Nirsevimab Against RSV-Related Outcomes.","authors":"Alexia Kieffer, Matthieu Beuvelet, Gerald Moncayo, Mersha Chetty, Aditya Sardesai, Robert Musci, Richard Hudson","doi":"10.1007/s40121-024-01037-7","DOIUrl":"10.1007/s40121-024-01037-7","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory syncytial virus (RSV) leads to significant morbidity in newborn infants in the United Kingdom (UK). Nirsevimab, a long-acting monoclonal antibody, received approval from the European Medicines Agency and has been licensed by the Medicines and Healthcare products Regulatory Agency for preventing RSV lower respiratory tract disease (LRTD) in neonates and infants during their first RSV season. The objective of this study was to assess the potential impact of nirsevimab on RSV-associated LRTDs, related costs, and loss of quality-adjusted life years (QALYs) in infants experiencing their first RSV season.</p><p><strong>Methods: </strong>The impact of administering nirsevimab across all infant populations compared to palivizumab in the high-risk palivizumab-eligible population was assessed via a static decision-analytic model specified for a UK birth cohort experiencing their first RSV season. The RSV-related health events of interest included primary care (PC), accident and emergency (A&E) visits, hospitalizations [including hospitalizations alone and those resulting in intensive care unit (ICU) admissions], recurrent wheezing in infants who were previously hospitalized, and all-cause LRTD hospitalizations.</p><p><strong>Results: </strong>Under the current standard of practice (SoP), RSV was estimated to result in 329,425 RSV LRTDs annually, including 24,381 hospitalizations and ICU admissions, representing £117.8 million (2024 GBP) in costs. Comparatively, universal immunization of all infants with nirsevimab could avoid 198,886 RSV LRTDs, including 16,657 hospitalizations and ICU admissions, resulting in savings of £77.2 million in RSV treatment costs. Considering the impact on all-cause LRTD of a universal immunization strategy, nirsevimab could be valued between £243 and £274, assuming willingness-to-pay (WTP) thresholds of £20,000 and £30,000 per QALY saved, respectively.</p><p><strong>Conclusions: </strong>This analysis demonstrated that the health and economic burden of RSV would be substantially reduced in all infants experiencing their first RSV season in the UK (including term, preterm, and palivizumab-eligible infants) as a result of a universal immunization strategy with nirsevimab.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11416453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Response to: A Letter to the Editor Regarding 'Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines Among Older Adults: Systematic Literature Review and Meta-Analysis Using the GRADE Framework'. 回应致编辑的一封信:关于 "mRNA-1273 和 BNT162b2 COVID-19 疫苗在老年人中的效果比较:使用 GRADE 框架的系统性文献综述和元分析"。
IF 4.7 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-24 DOI: 10.1007/s40121-024-01020-2
Ekkehard Beck, Mary T Bausch-Jurken, Nicolas Van de Velde, Xuan Wang, Mia Malmenäs
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引用次数: 0
Influenza-Associated Excess Mortality and Hospitalization in Germany from 1996 to 2018 1996 年至 2018 年德国与流感相关的超额死亡率和住院率
IF 5.4 3区 医学
Infectious Diseases and Therapy Pub Date : 2024-09-19 DOI: 10.1007/s40121-024-01043-9
Christian J. A. Schindler, Ian Wittenberg, Oliver Damm, Rolf Kramer, Rafael Mikolajczyk, Tonio Schönfelder
{"title":"Influenza-Associated Excess Mortality and Hospitalization in Germany from 1996 to 2018","authors":"Christian J. A. Schindler, Ian Wittenberg, Oliver Damm, Rolf Kramer, Rafael Mikolajczyk, Tonio Schönfelder","doi":"10.1007/s40121-024-01043-9","DOIUrl":"https://doi.org/10.1007/s40121-024-01043-9","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Influenza-associated excess mortality and morbidity is commonly estimated using statistical methods. In Germany, the Robert Koch Institute (RKI) uses the relative mortality distribution method (RMDM) to estimate influenza-associated excess mortality without reporting age-specific values. In order to better differentiate the distribution of the disease burden, a distinction by age is of high relevance. Therefore, we aimed to revise the existing excess mortality model and provide age-specific excess mortality estimates over multiple seasons. We also used the model to determine influenza-associated excess hospitalizations, since the RKI excess hospitalization model is currently based on another approach (i.e., combination of excess physician visits and hospitalized proportion).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This study was a retrospective data analysis based on secondary data of the German population from 1996–2018. We adapted the RKI’s method of estimating influenza-associated excess mortality with the RMDM and also applied this approach to excess hospitalizations. We calculated the number of excess deaths/hospitalizations using weekly and age-specific data.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Data available in Germany are suitable for addressing the restrictions of the RKI’s mortality model. In total, we estimated 175,858 (176,482 with age stratification) influenza-associated excess all cause deaths between 1995–1996 and 2017–2018 ranging from 0 (17 with age stratification) in 2005–2006 to 25,599 (25,527 with age stratification) in 2017–2018. Total influenza-associated excess deaths were comparable to RKI’s estimates in most seasons. Most excess deaths/hospitalizations occurred in patients aged ≥ 60 years (95.42%/57.49%) followed by those aged 35–59 years (3,80%/24,98%). Compared with our model, the RKI hospitalization model implies a substantial underestimation of excess hospitalizations (828,090 vs. 374,200 over all seasons).</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>This is the first study that provides age-specific estimates of influenza-associated excess mortality in Germany. The results clearly show that the main burden of influenza is in the elderly, for whom prevention and control measures should be prioritized.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142254511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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