Infectious Diseases and Therapy最新文献

{"title":"Meropenem-Vaborbactam for Treatment of Carbapenem-Resistant Enterobacterales: A Narrative Review of Clinical Practice Evidence.","authors":"Matteo Bassetti, Daniele Roberto Giacobbe, Antonio Vena, Garyphallia Poulakou, Gian Maria Rossolini, Alex Soriano, David P Nicolau","doi":"10.1007/s40121-025-01146-x","DOIUrl":"10.1007/s40121-025-01146-x","url":null,"abstract":"<p><p>Among drug-resistant bacteria, carbapenem-resistant Enterobacterales (CRE) are a major clinical challenge with limited options for treatment. In the last several years, new treatment options have emerged for CRE, including meropenem-vaborbactam (MVB). MVB was studied clinically in the TANGO-I and TANGO-II trials, which evaluated the combination in complicated urinary tract infections and in different types of CRE infections, respectively. To date, clinical data on the efficacy of MVB in treatment of CRE remain limited, but are needed to understand the efficacy of a drug in routine practice. Eight retrospective studies have investigated the use of MVB for CRE. In these analyses, the overall clinical success rate varied from 60 to 75%, while mortality rates at 30 days ranged from about 15 to 30%. Most of these investigations involved patients with KPC-producing CRE strains, but also patients with Gram-negative infections, of which 80% were CRE. In addition, a number of small case series and case reports have emerged describing the use of MVB. In both retrospective studies and case series/reports, there appeared to be no major safety concerns. Collectively, these data have shown that MVB can be considered to have promising efficacy in severe Klebsiella pneumoniae carbapenemase (KPC)-producing-CRE infections and is safe and well tolerated.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"973-989"},"PeriodicalIF":4.7,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995416","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}

{"title":"West Nile Virus Outbreak in Israel 2024 Compared with Previous Seasons: A Retrospective Study.","authors":"Guy Katzenellenbogen, Michal Canetti, Ili Margalit, Yonatan Shusterman, Alon Simchovitz-Gesher, Lior Naveh, Nadav Baharav, Miki Goldenfeld, Ana Belkin, Marina Brod, Anat Wieder-Finesod, Eyal Leshem, Erez Magiel, Itzchak Levy, Yaniv Lustig, Victoria Indenbaum, Nicola Maggio, Shahar Dekel, Bella Mechnik, Yovel Peretz, Noam Barda, Amir Tafesh, Dafna Yahav, Gili Regev-Yochay","doi":"10.1007/s40121-025-01140-3","DOIUrl":"10.1007/s40121-025-01140-3","url":null,"abstract":"<p><strong>Introduction: </strong>Since May 2024, Israel has been experiencing a large West Nile virus (WNV) outbreak. We aimed to compare the clinical characteristics and outcomes of hospitalized cases to previous years and identify predictors of poor outcomes.</p><p><strong>Methods: </strong>A retrospective study. We compared WNV infection cases hospitalized during the 2024 outbreak (from 29 May to 29 July) to cases hospitalized during 2018-2023. For the entire cohort, risk factors for poor outcomes were investigated using multivariable analyses. The primary outcomes were death and a composite outcome of 30-day all-cause mortality, prolonged hospitalization (≥ 28 days), or discharge to an institution.</p><p><strong>Results: </strong>We included 134 patients, 103 admitted during 2024 and 31 during 2018-2023. The majority (109/134, 81%) had neuroinvasive disease, mostly encephalitis. In 2024, patients were older, with a lower functional state, and a higher proportion were severely immunocompromised. Mortality was numerically higher in 2024 (15/103, 15% versus 2/31, 6%). Altogether, nearly 40% of patients had poor outcomes, including 13% (17/134) mortality and 25% (34/134) discharged to institutions. Nearly 30% of patients who were severely immunocompromised died; all had B-cell depletion. Age was the only significant predictor of poor outcomes in multivariable analysis; however, patients with B-cell depletion had > 3 times higher odds for mortality (odds ratio 3.26, 95% confidence interval 0.73-13.07).</p><p><strong>Conclusions: </strong>The large 2024 outbreak of WNV was associated with considerable mortality and functional impairment among hospitalized patients that was higher compared with previous years. Poor outcomes were particularly observed in older adults and patients with B-cell depletion. The observation of severe disease and poor outcomes in patients with B-cell depletion, as well as possible therapeutic implications, should be further investigated.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780047","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}

{"title":"Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Introduced at the First Clinical Visit: A Real-Life Single-Arm Single-center Retrospective Cohort Study.","authors":"Josip Begovac, Iva Lisičar, Vanja Romih Pintar, Snježana Židovec-Lepej, Ana Planinić, Šime Zekan","doi":"10.1007/s40121-025-01139-w","DOIUrl":"10.1007/s40121-025-01139-w","url":null,"abstract":"<p><strong>Introduction: </strong>Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral (ART) regimen. Croatia has centralized care for people living with HIV (PLWH) in a single center, with a same-day ART initiation model whenever suitable. This retrospective cohort study aimed to determine whether same-day BIC/FTC/TAF initiation in a real-life setting is an effective regimen for achieving viral suppression.</p><p><strong>Methods: </strong>We identified 107 ART-naïve PLWH who started BIC/FTC/TAF between May 2019 and December 2022. BIC/FTC/TAF was initiated within 24 h of the first clinical visit. To emulate a prospective clinical trial, we present our efficacy results for the whole population (intention-to-treat, ITT) and those evaluated (on treatment, OT).</p><p><strong>Results: </strong>A total of 107 PLWH were included; the mean age was 38.5 years, 103 (96.3%) were male, and all PLWH were white. The mean CD4 count was 343.8 cells/μl (26.2% had a CD4 count < 200 cells/μl), and the HIV-1 RNA was 4.9 log10 copies/ml (43.9% had > 100,000 copies/ml). Acute/recent infection was diagnosed in 32 (29.9%) PLWH, and 4 (3.7%) were HBsAg positive. At 12 months (range 9-15), the efficacy (HIV-1 RNA < 50 copies/ml) in the ITT analysis was 78.5%, and the OT efficacy was 91.3%. Among the 15 PLWH who did not have viral load (VL) measurements at 12 months, nine had a subsequent undetectable VL, three were lost to follow-up, two moved, and one died. No discontinuations of BIC/FTC/TAF were observed.</p><p><strong>Conclusions: </strong>In our real-life clinical setting, same-day treatment with BIC/FTC/TAF was an efficacious and feasible option for achieving viral suppression in treatment-naïve PLWH.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"867-880"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735801","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}

{"title":"Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study.","authors":"Klaus-Friedrich Bodmann, Stefan Hagel, Alessandra Oliva, Stefan Kluge, Alessandra Mularoni, Valentina Galfo, Marco Falcone, Mathias W Pletz, Simone Lindau, Nadja Käding, Jan T Kielstein, Michael Zoller, Carlo Tascini, Sebastian Kintrup, Dirk Schädler, Claudia Spies, Francesco G De Rosa, Szilvia Radnoti, Alessandra Bandera, Roberto Luzzati, Sam Allen, Loredana Sarmati, Antonio Cascio, Nikolaos Kapravelos, Chinari P K Subudhi, George Dimopoulos, Matthias G Vossen, Abhijit M Bal, Mario Venditti, Claudio M Mastroianni, Thomas Borrmann, Christian Mayer","doi":"10.1007/s40121-025-01125-2","DOIUrl":"10.1007/s40121-025-01125-2","url":null,"abstract":"<p><strong>Introduction: </strong>Intravenous fosfomycin (FOS) is a broad-spectrum antibiotic primarily used in combination therapy to treat severe infections caused by both Gram-positive (GP) and Gram-negative (GN) pathogens, including multi-drug resistant (MDR) bacteria. The aim of this study, the largest to date, was to evaluate the effectiveness, safety, usage patterns, and patient characteristics of FOS in a real-world setting.</p><p><strong>Methods: </strong>Interim analysis of an ongoing, prospective, non-interventional, multicentre study in five European countries, involving centres in Germany, Italy, the United Kingdom, Greece, and Austria.</p><p><strong>Results: </strong>A total of 716 patients were enrolled between January 2017 and November 2023 (mean age: 62.8 years, APACHE II: 18.3, SOFA: 6.7). Main indications for FOS were bacteraemia/sepsis (23.6%), complicated urinary tract infections (18.0%), and bone and joint infections (17.4%). Other indications included hospital-acquired/ventilator-associated pneumonia (11.0%), complicated skin and soft tissue infections (9.1%), bacterial meningitis/central nervous system (CNS) infections (7.8%), and infective endocarditis (6.4%). Most common pathogens identified were Staphylococcus aureus (31.4%, including methicillin-resistant S. aureus), Klebsiella spp. (including K. pneumoniae) (17.2%), Escherichia coli (14.2%), coagulase-negative staphylococci (12.9%), other Enterobacterales (10.9%), and Pseudomonas aeruginosa (8.4%). In 34.6% of patients, an MDR pathogen was involved. Carbapenem resistance (CR) was high in Klebsiella spp. infections (59/123, 48.0%). In most patients, FOS was used in combination therapy (90.2%). The median dose was 15 g/day. Overall, clinical success and clinical response were favourable with 75.3% and 83.4% at the end of FOS treatment. Clinical success rates in infections caused by MDR or CR pathogens were 78.0% and 81.8%, respectively. Microbiological cure was achieved in 82.4% of all patients. Electrolyte imbalances were the most frequently observed adverse drug reactions, while gastrointestinal disorders were rare.</p><p><strong>Conclusion: </strong>The results from this study suggest that FOS is a safe and effective option as combination partner in the treatment of patients with severe infections caused by both GP and GN pathogens, including deep-seated infections and/or involvement of MDR bacteria.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02979951.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"765-791"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663219","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}

{"title":"Clinical and Virologic Outcomes of Baloxavir Compared with Oseltamivir in Pediatric Patients with Influenza in Japan.","authors":"Nobuhisa Ishiguro, Ichiro Morioka, Takashi Nakano, Atsushi Manabe, Keiko Kawaguchi, Shintaro Tanaka, Masahiro Kinoshita","doi":"10.1007/s40121-025-01131-4","DOIUrl":"10.1007/s40121-025-01131-4","url":null,"abstract":"<p><strong>Introduction: </strong>Baloxavir marboxil, a cap-dependent endonuclease inhibitor, has proven efficacy against influenza. There are limited comparative data between baloxavir and oseltamivir in Japanese pediatric patients with influenza. We evaluated the clinical and virologic outcomes and assessed safety of baloxavir compared with oseltamivir for treating influenza in Japanese patients aged 6 to < 12 years.</p><p><strong>Methods: </strong>In this open-label, randomized (2:1) trial, patients received oral administration of either a single dose of baloxavir or a twice-daily 5-day course of oseltamivir. The primary efficacy endpoint was time to illness alleviation (TTIA). Other efficacy and safety endpoints were also assessed.</p><p><strong>Results: </strong>Of 199 enrolled patients (mean age: 9 years), 195 were randomized (baloxavir, n = 128; oseltamivir, n = 67). Of these, 50.8% had influenza A/H3N2, 37.4% influenza B, and 10.3% influenza A/H1N1pdm. Median (95% confidence interval) TTIA was 44.8 (41.5, 69.7) h and 72.2 (50.9, 96.9) h in the baloxavir group and the oseltamivir group, respectively. The median time to first cessation of virus shedding was shorter in the baloxavir vs. oseltamivir group (48.0 vs. 192.0 h). Before treatment, one patient had PA/I38X virus infection at baseline. After treatment, PA/I38X viruses were observed in 12 patients (11 A/H3N2 and 1 A/H1N1pdm). No serious adverse events, including death, were observed in either group.</p><p><strong>Conclusion: </strong>In this study, baloxavir showed the potential for shortening of symptom duration compared with oseltamivir, which suggests baloxavir as an important treatment option for patients with influenza aged 6 to < 12 years.</p><p><strong>Trial registration: </strong>The study was registered at the Japan Registry of Clinical Trial (jRCT) on November 11, 2020 (registration no. jRCTs011200011).</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"833-846"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742601","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}

{"title":"Xpert MTB/XDR Assay for Detection of Resistance to Isoniazid, Fluoroquinolone, Aminoglycoside, and Ethionamide Among Patients with Pulmonary Tuberculosis in Bangladesh.","authors":"S M Mazidur Rahman, Noshin Nawer Ruhee, Amiyo Haider, Md Jahid Hasan, Rumana Nasrin, Ahammad Shafiq Sikder Adel, Mohammad Khaja Mafij Uddin, Shahriar Ahmed, Aung Kya Jai Maug, Sayera Banu","doi":"10.1007/s40121-025-01127-0","DOIUrl":"10.1007/s40121-025-01127-0","url":null,"abstract":"<p><strong>Introduction: </strong>Early detection of drug resistance in patients with tuberculosis (TB) is crucial for prompt and effective treatment. This study evaluated the performance of Xpert MTB/XDR assay (Xpert XDR) for detecting resistance to isoniazid (INH), fluoroquinolones (FLQ), aminoglycosides (AMG), and ethionamide (ETH) in patients with pulmonary TB (PTB) in Bangladesh.</p><p><strong>Methods: </strong>Xpert XDR was performed on sputum samples from 793 Xpert MTB/RIF positive patients with PTB enrolled between April 2021 and March 2023. Results were compared with phenotypic drug susceptibility test (pDST) performed on Lowenstein-Jensen (L-J) media for the detection of resistance to INH, FLQ, AMG, and ETH. The performance of the assay was also compared between newly diagnosed or rifampicin (RIF)-sensitive versus re-treated or RIF-resistant patients with PTB.</p><p><strong>Results: </strong>Of 793 samples tested by Xpert XDR, indeterminate results for INH, FLQ, AMG, and ETH were observed for 3 (0.4%), 5 (0.6%), 33 (4.2%), and 0 (0%) isolates, respectively. The assay's sensitivity and specificity compared to pDST was 94.0% (95% CI 90.5-96.4; 264/281) and 97.3% (95% CI 95.4-98.5; 495/509), respectively for INH; 86.0% (95% CI 78.2-91.8; 98/114) and 99.3% (95% CI 98.3-99.3; 669/674), respectively for FLQ; 85.7% (95% CI 42.1-99.6; 6/7) and 99.9% (95% CI 99.3-100.0; 752/753), respectively for AMG; and 25.0% (95% CI 19.0-31.7; 48/192) and 96.7% (95% CI 94.9-98.0; 581/601), respectively for ETH. Agreement of Xpert XDR with pDST was almost perfect for detecting resistance to INH, FLQ, and AMG (kappa: 0.91, 0.89, and 0.86, respectively), but fair for ETH (kappa: 0.28). Xpert XDR performed significantly better among re-treated or RIF-resistant patients with TB compared to newly diagnosed or RIF-sensitive cases.</p><p><strong>Conclusions: </strong>Given the high performance, Xpert XDR assay can be programmatically implemented nationwide for rapid and accurate detection of resistance to INH, FLQ, and AMG in patients with PTB, aiding clinicians in selecting appropriate regimens for the treatment of drug-resistant TB.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"803-818"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143700381","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}

{"title":"It's Here, It's There, There's Fungi Everywhere: A Case Series Utilizing Rezafungin for Invasive Candidiasis.","authors":"Jacob M Keck, Ryan K Dare, Mitchell B Jenkins, Juan C Rico, Luke Grisham, Jennifer McDonald, Alina Viteri, Robert W Bradsher","doi":"10.1007/s40121-025-01120-7","DOIUrl":"10.1007/s40121-025-01120-7","url":null,"abstract":"<p><p>Rezafungin is a long-acting echinocandin with broad coverage against Candida. Rezafungin has primarily been indicated for candidemia, with limited literature available on its use for infections outside of the bloodstream. Herein, three patient cases are presented from an academic medical center. Infectious processes presented include drug-resistant mucosal candidiasis, prosthetic joint infection, and candidemia involving Candida auris. In all three cases, patients received rezafungin. Clinical response was demonstrated in all patients as was tolerability of rezafungin. Together these cases provide further evidence for the use of rezafungin, including its use for treatment of invasive infections other than candidemia.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"889-895"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604774","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}

{"title":"Healthcare Professionals' Knowledge, Attitudes, and Practices Regarding Respiratory Syncytial Virus Disease and Vaccination in Adults Aged 60 Years and Older.","authors":"Elizabeth M La, Carolyn Sweeney, Eric Davenport, Sarah Calhoun, Andrea Harmelink, David Singer","doi":"10.1007/s40121-025-01119-0","DOIUrl":"10.1007/s40121-025-01119-0","url":null,"abstract":"<p><strong>Introduction: </strong>The burden of respiratory syncytial virus (RSV) disease is substantial among adults aged ≥ 60 years and adults with risk factors for severe RSV. This study assessed the knowledge, attitudes, and practices of healthcare professionals (HCPs) related to RSV disease and vaccination, with a focus on adults aged ≥ 60 years.</p><p><strong>Methods: </strong>During November 14-30, 2023, a cross-sectional, web-based survey was administered to HCPs, targeting a total of 600 primary care physicians (PCPs), specialist physicians, nurse practitioners (NPs)/physician assistants (PAs), and pharmacists. Survey questions evaluated knowledge about RSV disease, vaccines, and vaccination recommendations; RSV-related attitudes and perceptions; and RSV vaccination practices. Responses were analyzed descriptively, overall and by HCP subgroup. Multivariable logistic regression models were used to explore HCP characteristics associated with RSV vaccination knowledge and practices.</p><p><strong>Results: </strong>Of the 603 respondents (148 PCPs, 151 specialist physicians, 150 NPs/PAs, and 154 pharmacists), 63.0% were very familiar with RSV disease in patients aged ≥ 60 years. Although most HCPs recognized the benefits of RSV vaccination within this patient population, many HCPs were not fully knowledgeable about RSV vaccine recommendations, and 33.5% had not recommended, prescribed, or administered any RSV vaccine to patients aged ≥ 60 years in the previous 3 months. In multivariable regression analyses, HCP familiarity with RSV disease (among other factors) was consistently associated with RSV vaccination knowledge and practices.</p><p><strong>Conclusions: </strong>This study characterized RSV disease- and vaccine-related knowledge, attitudes, and practices among HCPs in the United States during the first season of RSV vaccine availability for adults aged ≥ 60 years. These findings can help to inform HCP and patient education efforts to address potential RSV vaccination knowledge gaps and ensure equitable access to RSV vaccines among older adults.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"735-752"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993526/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624385","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}

{"title":"Cost-Effectiveness and Public Health Impact of Universal Prophylaxis with Nirsevimab Against Respiratory Syncytial Virus (RSV) Infections in all Infants in Japan.","authors":"Shinichi Noto, Alexia Kieffer, Samira Soudani, Takeshi Arashiro, Chiho Tadera, Sebastien Eymere, Tobiasz Lemański, Xinyu Wang","doi":"10.1007/s40121-025-01134-1","DOIUrl":"10.1007/s40121-025-01134-1","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract disease, and the standard prevention strategy in Japan is limited to high-risk infants. Nirsevimab provides protection against medically attended (MA) RSV infection in healthy late-preterm and term infants and was approved in Japan in 2024. This study estimates the cost-effectiveness of universal immunization with nirsevimab in an all-infant population from the Japanese public healthcare payer perspective.</p><p><strong>Methods: </strong>A static decision analytic model, able to track costs and health outcomes in a cohort of infants, was adapted to the Japanese setting. The standard of care, palivizumab, administered to high-risk infants, was compared with nirsevimab administrated to all infants in the first year, and an additional increased dose of nirsevimab (200 mg) in the second season for high-risk infants. Differences in costs and quality-adjusted life years (QALYs) were captured considering RSV-related MA health events requiring inpatient hospitalizations, emergency room visits, and primary care visits, as well as RSV-related complications. Sensitivity and scenario analyses were conducted to explore the robustness and uncertainty of the study.</p><p><strong>Results: </strong>Assuming a price of ¥45,000 for nirsevimab, universal immunization with nirsevimab was found to be cost-effective with an incremental cost-effectiveness ratio (ICER) of ¥4,537,256/QALY. At the Japanese willingness-to-pay threshold of ¥5,000,000, the economically justifiable price was ¥45,496. Using the societal perspective, the ICER decreased to ¥1,695,635/QALY. Nirsevimab has a substantial public health impact on RSV disease burden, reducing approximately 50% of RSV-associated health events in an all-infant population.</p><p><strong>Conclusion: </strong>The analysis demonstrated that universal prophylaxis strategy with nirsevimab would significantly reduce the health and economic burden associated with RSV among infants in Japan. At the assumed price, nirsevimab can provide a cost-effective prophylaxis option against RSV infection in an all-infant population not limited to infants born prematurely or with high risk.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"847-865"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735803","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}

{"title":"Characteristics and Real-World Outcomes of Patients Treated with Fecal Microbiota, Live-jslm (RBL) for the Prevention of Recurrent Clostridioides difficile Infection.","authors":"Sahil Khanna, Sanghyuk Seo, Min Yang, Viviana Garcia-Horton, Yipeng Gao, Hannah H Kim, Loren Ormenaj, Amy Guo","doi":"10.1007/s40121-025-01130-5","DOIUrl":"10.1007/s40121-025-01130-5","url":null,"abstract":"<p><strong>Introduction: </strong>Recurrent Clostridioides difficile infection (rCDI) is common, with symptoms ranging from diarrhea to life-threatening sepsis. This study aimed to assess the real-world outcomes of patients with rCDI in the United States (US) who received fecal microbiota, live-jslm (RBL), the first US Food and Drug Administration-approved microbiota-based therapy for the prevention of rCDI after antibiotic treatment.</p><p><strong>Methods: </strong>Adults with rCDI who received RBL between July 2023 and August 2024 at home or in a clinic and had ≥ 8 weeks of follow-up or experienced CDI recurrence at any time after RBL administration were included. Treatment success, defined as no CDI recurrence within 8 weeks of RBL, was assessed overall and in subgroups stratified by age, number of prior CDI recurrences, duration of the antibiotic washout period, prior bezlotoxumab use, and RBL administration setting.</p><p><strong>Results: </strong>Among 196 patients who received RBL, 176 had either ≥ 8 weeks of follow-up or had < 8 weeks of follow-up but experienced CDI recurrence during that period. The treatment success rate at 8 weeks was 83.0%. No significant differences were observed in treatment success rates among subgroups based on age (< 65 years old vs. ≥ 65 years old: 85.9% vs. 80.2%, p = 0.20), duration of the antibiotic washout period (24 h: 80.0%, 48 h: 84.5%, 72 h: 85.0%, p = 0.68), number of prior CDI recurrences (< 3 vs. ≥ 3: 82.5% vs. 83.1%, p = 0.60), or prior bezlotoxumab use (86.4% vs. 83.7%, p = 1.00). Patients receiving RBL at home had a higher treatment success rate compared to those receiving RBL in a clinic (87.3% vs. 62.5%, p < 0.01).</p><p><strong>Conclusions: </strong>RBL was highly effective in preventing rCDI in a real-world setting, including at-home administration. The effectiveness was also observed among high-risk subgroups, such as patients ≥ 65 years old and those with ≥ 3 prior CDI recurrences.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"793-802"},"PeriodicalIF":4.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11993521/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676662","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}