Guillaume Béraud, Anne Mosnier, Olivier Guérin, Nathalie Cugnardey, Sandrine Gillet, Justine Haond, Stéphane Simon, Quentin Berkovitch, Pierre Gamblin, Henri Lesage, Paul Loubet
{"title":"Cost-Effectiveness Analysis of Expanding Influenza Vaccination to Adults Aged 50 and Over in France.","authors":"Guillaume Béraud, Anne Mosnier, Olivier Guérin, Nathalie Cugnardey, Sandrine Gillet, Justine Haond, Stéphane Simon, Quentin Berkovitch, Pierre Gamblin, Henri Lesage, Paul Loubet","doi":"10.1007/s40121-025-01168-5","DOIUrl":"https://doi.org/10.1007/s40121-025-01168-5","url":null,"abstract":"<p><strong>Introduction: </strong>Influenza in France causes, on average, more than 1 million primary care consultations, 20,000 hospitalizations, and 9000 deaths annually. Adults over 50 years of age face higher risks of severe influenza due to increasing chronic conditions associated with aging, yet vaccination rates in this group are low, as recommendations start from age 65. This study explores the potential health and economic benefits of expanding vaccination recommendations to individuals aged 50 and over.</p><p><strong>Methods: </strong>Using the literature and French health insurance data, a SEIR (susceptible-exposed-infectious-recovered) model was developed. The subpopulations were stratified by age, vaccination status, and risk profile. Various expanded vaccination strategies were compared to the current strategy, assessing impacts on epidemiological outcomes (consultations, hospitalizations, deaths), economic metrics (vaccination costs, medical care expenses), and quality-adjusted life years (QALY). The model's robustness was tested with deterministic and probabilistic sensitivity analyses.</p><p><strong>Results: </strong>Expanded vaccination recommendations for individuals over 50 years of age lead to an average reduction of 500,124 consultations, 9486 hospitalizations, and 2990 deaths, with an associated additional cost of 58 million euros compared to the current vaccination strategy. The cost-effectiveness analysis estimates an incremental cost-effectiveness ratio (ICER) of €1496/QALY. When considering indirect costs, the total savings in this expanded vaccination scenario amount to €- 314,308,377, resulting in a dominant ICER. This indicates that the strategy would not only be more cost-effective but also cost-saving compared to the current approach.</p><p><strong>Conclusions: </strong>Expanding vaccination recommendations for low-risk adults over 50 is cost-effective and represents a significant public health opportunity.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247726","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}
Mohammed Al Musawa, Ashlan J Kunz Coyne, Sara Alosaimy, Kristen Lucas, Melanie Rae Schrack, Justin Andrade, Shelbye R Herbin, Mark Biagi, Michael Pierce, Kyle C Molina, Nicholson B Perkins, Reese Cosimi, Lena Kang-Birken, Madeline A King, Benjamin M Pullinger, Leonor M Rojas, Jeannette Bouchard, Athena L V Hobbs, Jazmin Agee, Kaylee E Caniff, Sean R Van Helden, Michael P Veve, Michael J Rybak
{"title":"Clinical Outcomes of Eravacycline in Patients Treated for Stenotrophomonas maltophilia Infections.","authors":"Mohammed Al Musawa, Ashlan J Kunz Coyne, Sara Alosaimy, Kristen Lucas, Melanie Rae Schrack, Justin Andrade, Shelbye R Herbin, Mark Biagi, Michael Pierce, Kyle C Molina, Nicholson B Perkins, Reese Cosimi, Lena Kang-Birken, Madeline A King, Benjamin M Pullinger, Leonor M Rojas, Jeannette Bouchard, Athena L V Hobbs, Jazmin Agee, Kaylee E Caniff, Sean R Van Helden, Michael P Veve, Michael J Rybak","doi":"10.1007/s40121-025-01170-x","DOIUrl":"https://doi.org/10.1007/s40121-025-01170-x","url":null,"abstract":"<p><strong>Introduction: </strong>Stenotrophomonas maltophilia is notable for its rising incidence and multidrug resistance, which complicates treatment. As a result of insufficient clinical studies, the 2024 Infectious Diseases Society of America (IDSA) Guidance on Treating Antimicrobial Resistant Gram-negative Infection advises against using eravacycline (ERV) for S. maltophilia infections. We present real-world data on patients treated with ERV for these infections.</p><p><strong>Methods: </strong>This multicenter, retrospective, observational study included adult patients who received ERV for treating S. maltophilia infections for ≥ 72 h between October 2018 and August 2022. The primary outcome was the clinical cure evaluated at the end of ERV therapy. Key secondary outcomes included a 30-day survival rate, absence of infection recurrence counting from the end of ERV therapy, and occurrence of possible ERV-related adverse effects (AE) noted in the patient's records.</p><p><strong>Results: </strong>Overall, 41 patients were included with a median (interquartile range [IQR]) age of 63 years (46.0-74.5). Most patients were male (63.4%) and white (51.2%). The primary source of infection was pulmonary (56.1%), and most patients received ERV for regimen consolidation (65.9%). Combination therapy was used in about 10% of the cases for S. maltophilia treatment. The median (IQR) duration of ERV treatment was 7 days (4.0-11.5). The clinical cure rate was 73.2%, and the 30-day survival rate was 68.3%. Four patients (9.8%) experienced possible AE from ERV.</p><p><strong>Conclusion: </strong>S. maltophilia infections are challenging to treat because of limited options. An analysis of 41 patients indicates ERV may be an acceptable treatment option, but more clinical studies are needed to evaluate its efficacy and safety.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247725","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}
Jessica Presa, Ruth Carrico, Jaime E Fergie, Stephanie Hanenberg, Gary S Marshall, Kaitlyn Rivard, Jana Shaw, Gregory D Zimet, Paula Peyrani, Alejandro Cane
{"title":"Preventing Meningococcal Disease in US Adolescents and Young Adults Through Vaccination.","authors":"Jessica Presa, Ruth Carrico, Jaime E Fergie, Stephanie Hanenberg, Gary S Marshall, Kaitlyn Rivard, Jana Shaw, Gregory D Zimet, Paula Peyrani, Alejandro Cane","doi":"10.1007/s40121-025-01166-7","DOIUrl":"https://doi.org/10.1007/s40121-025-01166-7","url":null,"abstract":"<p><p>In 2022, experts convened under the name Advancing Strategies to Prevent Meningococcal Disease (ARTEMIS) to gather insights on issues related to invasive meningococcal disease (IMD) and meningococcal vaccination in the US. Discussions regarding successes, challenges, and future directions for the US meningococcal vaccination program are summarized. Current vaccination recommendations target adolescents/young adults (AYA), who are at increased risk of IMD. Suboptimal vaccination rates, particularly for meningococcal serogroup B disease, may stem from gaps in knowledge surrounding IMD and meningococcal vaccination among healthcare providers (HCPs), parents, and AYA; confusion among HCPs regarding the shared clinical decision-making recommendation for serogroup B vaccinations; demographic variables; and lack of preventive healthcare visits. ARTEMIS proposed strategies to address knowledge gaps and access barriers at the HCP, parent/AYA, and educational institution/policymaker levels. Alternative vaccination schedules using a recently approved MenABCWY vaccine that provides protection against all five major serogroups may simplify meningococcal vaccination and increase coverage.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215725","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":"Economic Evaluation of PHID-CV versus PCV10-SII Compared with no Vaccination in the Philippines.","authors":"Nurilign Ahmed, Ru Han, Edwin Rodriguez, Gyneth Lourdes Bibera, Edgardo Ortiz, Olakunle Oladehin, Jorge A Gomez","doi":"10.1007/s40121-025-01162-x","DOIUrl":"https://doi.org/10.1007/s40121-025-01162-x","url":null,"abstract":"<p><strong>Introduction: </strong>Streptococcus pneumoniae can cause serious invasive pneumococcal disease (IPD), such as pneumonia, meningitis and bactaeremia. Two pneumococcal polysaccharide conjugate vaccines (PCV), the 13-valent PCV13 and 10-valent PHiD-CV, are included in the Philippines' National Formulary and implemented in the national immunisation programme. Recently, a new 10-valent PCV (PCV10-SII) has received World Health Organization prequalification status. The objective of this study was to assess cost-effectiveness of the two 10-valent PCVs versus no vaccination and the relative cost-effectiveness of the two vaccines.</p><p><strong>Methods: </strong>An existing Markov model was adapted to the Philippines context. Health outcomes, including bacteraemia, meningitis, pneumonia, acute otitis media (AOM), sequelae and death, were evaluated over a 5-year horizon without discounting. Quality-adjusted life years (QALYs) and costs were calculated over a lifetime horizon, applying a discount rate of 3.66%. The price of PCV10-SII was assumed to be 20% below the PHiD-CV market price; this price reduction was varied between 5% and 15% in scenario analyses.</p><p><strong>Results: </strong>Both vaccination strategies dominated the 'no vaccination' strategy, producing more health benefits at lower total costs. The incremental cost-effectiveness ratio of PHiD-CV versus PCV10-SII was 54,553 Philippine pesos (PHPs) per QALY gained in the base case analysis. Vaccination with PHiD-CV was predicted to yield more QALYs compared with PCV10-SII (ΔQALY: 2929) since more cases of meningitis, bactaeremia and AOM were prevented but at higher direct costs due to the vaccine price difference. PHiD-CV would be the dominant option if the price reduction for PCV10-SII was at most 5%.</p><p><strong>Conclusions: </strong>Both vaccination strategies are superior to no vaccination, producing more health benefits at lower costs. QALYs gained are higher with PHiD-CV but at higher direct costs. Results are most sensitive to assumptions about PCV10-SII vaccine price.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198975","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}
Javier Díez-Domingo, Róbert Simkó, Giancarlo Icardi, Chan Poh Chong, Céline Zocchetti, Olga Syrkina, Siham Bchir, Isabelle Bertrand-Gerentes
{"title":"Correction: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study.","authors":"Javier Díez-Domingo, Róbert Simkó, Giancarlo Icardi, Chan Poh Chong, Céline Zocchetti, Olga Syrkina, Siham Bchir, Isabelle Bertrand-Gerentes","doi":"10.1007/s40121-025-01150-1","DOIUrl":"10.1007/s40121-025-01150-1","url":null,"abstract":"","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1379-1380"},"PeriodicalIF":4.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12151926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985631","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}
Nilay Thakkar, Rulan Griesel, Amy Pierce, Veronica Bainbridge, Bronagh Shepherd, Konstantinos Angelis, Andrew Tomlinson, Yash Gandhi, Darin Brimhall, Daijha Anderson, Susan Andrews, Carolina Acuipil, Cynthia McCoig, Mark Baker, Paul Benn
{"title":"Clinical Pharmacokinetics and Safety of a New HIV-1 Capsid Inhibitor, VH4004280, After Oral Administration in Adults Without HIV.","authors":"Nilay Thakkar, Rulan Griesel, Amy Pierce, Veronica Bainbridge, Bronagh Shepherd, Konstantinos Angelis, Andrew Tomlinson, Yash Gandhi, Darin Brimhall, Daijha Anderson, Susan Andrews, Carolina Acuipil, Cynthia McCoig, Mark Baker, Paul Benn","doi":"10.1007/s40121-025-01154-x","DOIUrl":"10.1007/s40121-025-01154-x","url":null,"abstract":"<p><strong>Introduction: </strong>The pharmacokinetics, drug-drug interaction potential, and safety of a new HIV-1 capsid inhibitor, VH4004280 (VH-280), are described in this first-time-in-human study.</p><p><strong>Methods: </strong>This randomized, double-blind, placebo-controlled, phase 1 study assessed oral VH-280 in adults without HIV. In parts 1 and 3, VH-280 was administered as powder-in-bottle (PiB) and tablet formulations, respectively, in single ascending doses. In part 2, VH-280 was administered as a PiB formulation once daily for 14 days in multiple ascending doses. In addition, in part 2, the effect of VH-280 on cytochrome P450 3A (CYP3A) activity was evaluated using midazolam as a probe substrate.</p><p><strong>Results: </strong>In total, 73 participants were included (VH-280, n = 57; placebo, n = 16). Plasma exposures for VH-280 were broadly dose-proportional, and median time to maximum observed concentration was 9.0-17.0 h for the PiB and tablet formulations. Geometric mean terminal half-life was 145.8-207.8 h (> 6 days). Compared with PiB, exposures for the tablet formulation were 45-56% lower. Concomitant administration of midazolam after single and multiple doses of VH-280 did not result in clinically significant changes in midazolam or 1-hydroxymidazolam exposures; therefore, VH-280 is not anticipated to inhibit or induce CYP3A4. VH-280 was well-tolerated. Frequency of adverse events (AEs) was comparable between placebo and VH-280 groups. Adverse events related to VH-280 were primarily grade 1. There were no serious AEs, AEs leading to withdrawal from drug or study, or deaths. No trends in vital signs, electrocardiograms, or laboratory hematology parameters were observed, and there were no clinically relevant changes in chemistry parameters.</p><p><strong>Conclusions: </strong>Data from this first-time-in-human study further characterize the pharmacokinetics of VH-280 after oral administration, providing support for the development of new capsid inhibitors as part of a complete long-acting regimen for the treatment and prevention of HIV-1.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, NCT05163522.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1313-1326"},"PeriodicalIF":4.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12151970/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998804","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}
Nikolaos Giannelos, Desmond Curran, Sean Matthews, Justin Carrico, Anthony L Cunningham
{"title":"The Potential Impact of Increased Recombinant Zoster Vaccine Uptake in Older Adults Worldwide.","authors":"Nikolaos Giannelos, Desmond Curran, Sean Matthews, Justin Carrico, Anthony L Cunningham","doi":"10.1007/s40121-025-01161-y","DOIUrl":"10.1007/s40121-025-01161-y","url":null,"abstract":"<p><strong>Introduction: </strong>Herpes zoster (HZ, Shingles) is a vaccine-preventable viral disease impacting patients' quality of life owing to pain and rash. An estimated 15 million HZ cases occur annually in individuals aged ≥ 50 years worldwide. Recombinant zoster vaccine (RZV) is effective in protecting against HZ. This is the first study evaluating the potential incremental public health benefits in terms of HZ cases averted worldwide by vaccinating adults aged ≥ 50 years with RZV.</p><p><strong>Methods: </strong>A previously published static multi-cohort Markov model with an annual cycle length and lifetime horizon was used for all analyses. Demographic data depicting populations on 31 December 2023, and age-sex specific mortality rates by region were sourced from United Nations (2022). HZ incidence rates were informed from a recent meta-regression analysis of global HZ burden (Asia, Europe, Northern America, Oceania, and worldwide). RZV efficacy and waning modelling was based on 11-year clinical trial follow-up data [NCT02723773].</p><p><strong>Results: </strong>Assuming 70% second-dose compliance in the general population aged ≥ 50 years worldwide, increased RZV uptake by 5% reduced the number of expected HZ cases by > 10 million over the vaccinated cohort's remaining lifetime. More than 5 million of the averted cases were among the cohort vaccinated at ages 50-59 years. Numbers needed to vaccinate (NNV) to avert one HZ case worldwide ranged from 9 at 50-59 years to 18 at ≥ 80 years-of-age, with an overall NNV of 10 for the entire cohort aged ≥ 50 years. Variations observed by region and vaccination age reflected varying inputs, i.e., population counts, HZ incidence rates, mortality rates, and vaccine efficacy waning by age.</p><p><strong>Conclusions: </strong>A modest (5%) increase in absolute RZV uptake worldwide was estimated to avert millions of additional HZ cases. Lower NNVs were observed in younger vaccinated cohorts irrespective of region, outlining the merits of long-term protection afforded by RZV, and suggesting that earlier vaccination with RZV may be a more effective public health policy against HZ. Greater numbers of averted HZ cases and lower NNVs estimated at ideal second dose compliance demonstrated the importance of timely series completion.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1327-1341"},"PeriodicalIF":4.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12151947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119656","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}
Soyoung Oh, Sujin An, Kihyun Park, Soohyung Lee, Yoo Min Han, Seong-Joon Koh, Joowon Lee, Hyerin Gim, Donghyun Kim, Haesook Seo
{"title":"Gut Microbial Signatures in Long COVID: Potential Biomarkers and Therapeutic Targets.","authors":"Soyoung Oh, Sujin An, Kihyun Park, Soohyung Lee, Yoo Min Han, Seong-Joon Koh, Joowon Lee, Hyerin Gim, Donghyun Kim, Haesook Seo","doi":"10.1007/s40121-025-01167-6","DOIUrl":"https://doi.org/10.1007/s40121-025-01167-6","url":null,"abstract":"<p><strong>Introduction: </strong>Following severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection, symptoms can persist for more than 12 weeks in over 10% of patients in a condition known as long coronavirus disease (COVID). Gut microbiota dysbiosis is correlated with long COVID, but the specific relationship between long COVID and the gut microbiome remains unclear. Here, we aimed to investigate connections between the gut microbiota and long COVID severity.</p><p><strong>Methods: </strong>Fecal samples were collected from 31 patients with long COVID, 14 with COVID-19 but not long COVID, and 23 healthy controls. The mean interval between COVID-19 diagnosis and sample collection was 65.5 (range: 13.0-110.3) weeks for patients with long COVID and 74.8 (range: 50.7-110.4) weeks for positive control group. Gut microbiota composition was analyzed using 16S rRNA gene sequencing. Patient-reported outcomes were used to comprehensively assess long COVID symptom severity.</p><p><strong>Results: </strong>Symptom severity was higher in patients with severe initial infections and significantly correlated with serum triglyceride, fasting blood glucose, and high-density lipoprotein-cholesterol levels. Results showed distinct microbial profiles in patients with long COVID. Leuconostoc, Actinomyces, and Granulicatella were significantly enriched, and they accurately distinguished patients with long COVID from controls, indicating their potential as long COVID biomarkers. Particular gut bacteria were significantly correlated with certain systemic, gastrointestinal, otolaryngologic, and visual symptoms. Parabacteroides, Eubacterium ventriosum group, and Rothia abundance was correlated with blood biomarkers that influence long COVID development, including total and low-density lipoprotein cholesterol and basophil levels.</p><p><strong>Conclusions: </strong>The gut microbial signature of patients with long COVID differed from that of healthy controls. Certain microbial genera showed significant differences between patients with long COVID and controls, suggesting potential as preliminary biomarkers and therapeutic targets for long COVID pending validation in larger studies.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198976","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}
Eliazar Sabater Cabrera, Claire Trennery, Amy M Jones, Natasha Griffiths, Elizabeth Foley, Matthew M Hamill, Magdalena Schwarz
{"title":"Real-Life Experiences of Herpes Simplex Virus Type 2 Genital Herpes in the United States: A Structured Literature Review and Qualitative Concept Elicitation Study.","authors":"Eliazar Sabater Cabrera, Claire Trennery, Amy M Jones, Natasha Griffiths, Elizabeth Foley, Matthew M Hamill, Magdalena Schwarz","doi":"10.1007/s40121-025-01118-1","DOIUrl":"10.1007/s40121-025-01118-1","url":null,"abstract":"<p><strong>Introduction: </strong>Research on real-life experiences of herpes simplex virus type 2 (HSV-2) genital herpes (GH) is scarce. This study primarily aimed to characterize the signs/symptoms and impacts of Ý (HRQoL) of people living with HSV-2 GH in the United States. The secondary aim was to map the identified signs/symptoms and impact concepts onto existing patient-reported outcome (PRO) measures to assess PRO coverage.</p><p><strong>Methods: </strong>A structured literature review and concept elicitation (CE) interviews were conducted based on predefined eligibility criteria. The literature search was conducted across three digital databases and publicly available online resources. The CE interviews were conducted among three participant groups with a confirmed HSV-2 GH diagnosis. A conceptual model was developed based on signs/symptoms and HRQoL impact concepts, identified from the literature review and CE interviews. Key concepts from the model were mapped onto three existing PRO instruments [Herpes Symptoms Checklist (HSC), Herpes Outbreak Impact Questionnaire (HOIQ), and Recurrent Genital Herpes Quality of Life questionnaire (RGHQoL)] to assess concept coverage.</p><p><strong>Results: </strong>Overall, 26 records were included in the literature review and 30 participants were recruited for CE interviews. The final conceptual model included 35 signs/symptoms and 59 impact concepts categorized among 6 and 9 domains, respectively. Most frequently reported signs/symptoms were itching, sores/lesions/blisters, and body pain. Sores/lesions/blisters were reported as most bothersome. Most frequently reported impact concepts were anxiety and worry, concerns about disclosing diagnosis, and loss of self-esteem/confidence. Conceptual mapping revealed that, when used together, existing PRO instruments provided comprehensive coverage of most concepts (HSC 83%, HOIQ 56%, and RGHQoL 50% of domains covered, respectively).</p><p><strong>Conclusions: </strong>Participants experienced a range of signs/symptoms and HRQoL impacts. Existing PRO measures provided comprehensive coverage of recurrent HSV-2 GH specific concepts for the domains they measured.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1239-1264"},"PeriodicalIF":4.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12151961/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963439","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}
Mondher Toumi, Ruth Pulikottil-Jacob, Karina Watts, Isaac Odeyemi, Karin Butler
{"title":"An Economic Model to Assess the Cost Impact of Using Xpert Carba-R to Screen Carbapenemase-Producing Enterobacterales in Comparison with Standard of Care, in a National Health Service Setting.","authors":"Mondher Toumi, Ruth Pulikottil-Jacob, Karina Watts, Isaac Odeyemi, Karin Butler","doi":"10.1007/s40121-025-01141-2","DOIUrl":"10.1007/s40121-025-01141-2","url":null,"abstract":"<p><strong>Introduction: </strong>Carbapenemase-producing Enterobacterales (CPE) are bacteria that produce carbapenemases, enzymes that destroy carbapenem antibiotics and result in carbapenem resistance. Early identification of individuals who have been colonised or infected is important to correctly implement infection prevention and control procedures. Chromogenic media culture is traditionally the most common method of screening for high-risk patients. However, there is a long wait for results, which has substantial cost and operational implications. Xpert Carba-R is a rapid molecular test that provides CPE screening results in 50 min. This study aimed to assess the cost impact of high-risk CPE screening with Xpert Carba-R compared with media culture.</p><p><strong>Methods: </strong>An economic model was developed using a probabilistic cost-comparison approach to estimate the costs associated with Xpert Carba-R, from a National Health Service and personal social services perspective. The model cohort was individuals at high risk of CPE colonisation and used an 8.30-day mean time horizon for all patients to cover hospitalisation time, with an extra 5.80 days added for patients that were truly colonised to cover the time they would spend in isolation (14.10-day time horizon overall). Deterministic sensitivity analysis and scenario analysis were used to determine the robustness of the findings.</p><p><strong>Results: </strong>The model found that Xpert Carba-R is cost saving compared with media culture, with incremental cost savings of £818.28 per person. Despite greater technology costs, there are cost savings associated with preventing unnecessary isolation.</p><p><strong>Conclusion: </strong>The analysis found Xpert Carba-R to be cost saving compared with media culture for CPE screening in high-risk patients. The model did not explore onwards transmission or the opportunity cost of releasing isolation spaces, so the cost savings are likely to be far greater than those demonstrated in this study.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1265-1276"},"PeriodicalIF":4.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12151960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014777","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}