Infectious Diseases and Therapy最新文献

{"title":"Initial Experiences with Invasive Meningococcal Disease: Insights from Survivors and Their Caregivers.","authors":"Oscar Herrera-Restrepo, Nuzhat Afroz, Eliazar Sabater Cabrera, Matthew Reaney, France Ginchereau Sowell, Ramiya Kumar, Alicia Stillman, Patti Wukovits, Mariana Rodrigues, Sofia B Pinto, Zeki Kocaata, Obinna Onwude","doi":"10.1007/s40121-024-01061-7","DOIUrl":"10.1007/s40121-024-01061-7","url":null,"abstract":"<p><strong>Introduction: </strong>Invasive meningococcal disease (IMD) has a low incidence but is a life-threatening illness with a 10-15% mortality rate. Even with timely treatment, survivors may experience acute and long-term health complications. While meningococcal vaccines are recommended for adolescents and young adults in the USA, vaccination coverage remains uneven across serotypes. This study investigated the physical, social, psychological, and economic burden of IMD on survivors and their caregivers in the USA during the acute phase (Part 1, presented in this manuscript) and the long-term phase (Part 2, presented in a separate manuscript) of IMD.</p><p><strong>Methods: </strong>This study implemented a non-interventional, mixed-methods approach using a bespoke survey and qualitative interviews (designed on the basis of a preliminary conceptual model of IMD) with US survivors and their caregivers.</p><p><strong>Results: </strong>A total of 11 survivors (1 adolescent, 10 adults) and 3 caregivers participated in the study. Survivors contracted IMD during infancy (n = 2), childhood (n = 3), or adulthood (n = 6), and often described leading healthy lives pre-IMD. At IMD onset, interactions with the healthcare system impacted participants' experiences; confusion and care delays were common, and procedures were often invasive (e.g., amputations). Survivors commonly experienced symptoms including skin rash (7/11), fever (6/11), and unconsciousness (6/11), consistent with caregivers' reports. Survivors able to report on the short-term impacts of IMD (n = 9) described functional limitations (9/9), emotional impacts (6/9) such as fear and trauma, and school (6/9), work (4/9), and financial (5/9) challenges. Caregivers also experienced emotional impacts (3/3) and family (2/3), work (3/3), and financial (3/3) impacts during the acute phase.</p><p><strong>Conclusions: </strong>IMD places a significant humanistic burden on survivors and their caregivers during the acute phase. Results from Part 1 of this study indicate a need for increased disease awareness and healthcare provider education, expeditious diagnosis, and improved access to prevention methods such as available meningococcal vaccines. A video abstract is available with this article. Video abstract (MP4 1,24,432 kb).</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2581-2595"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521840","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 Analysis of the Use of V116, a 21-Valent Pneumococcal Conjugate Vaccine, in Vaccine-Naïve Adults Aged ≥ 65 Years in the United States.","authors":"Zinan Yi, Kwame Owusu-Edusei, Elamin Elbasha","doi":"10.1007/s40121-024-01067-1","DOIUrl":"10.1007/s40121-024-01067-1","url":null,"abstract":"<p><strong>Introduction: </strong>Given the recent approval and recommendation of V116, a 21-valent pneumococcal conjugate vaccine (PCV), in the United States (US), we evaluated the cost-effectiveness of using V116 versus the 20-valent PCV (PCV20) or the 15-valent PCV (PCV15) in series with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults aged ≥ 65 years in the US who had never received a PCV previously.</p><p><strong>Methods: </strong>A static multi-cohort state-transition Markov model was developed to estimate the lifetime incremental clinical and economic impact of V116 vs. PCV20 or PCV15 + PPSV23 from the societal perspective. All model inputs were based on published literature and publicly available databases and/or reports. Model outcomes included undiscounted clinical cases: invasive pneumococcal disease (IPD), inpatient and outpatient non-bacteremic pneumococcal pneumonia (NBPP), post-meningitis sequelae (PMS), deaths from IPD and inpatient NBPP, discounted quality-adjusted life years (QALYs) as well as the discounted total cost (in 2023 USD), which consisted of vaccine acquisition and administration costs, direct and indirect costs associated with the disease, and travel costs for vaccination. The final summary measure was the incremental cost-effectiveness ratio (ICER), reported as $/QALY gained. Three percent was used for the annual discounting rate.</p><p><strong>Results: </strong>Based on the inputs and assumptions used, the results indicated that the V116 strategy prevented 27,766 and 32,387 disease cases/deaths and saved $239 million and $1.8 billion in total costs when compared to the PCV20 and PCV15 + PPSV23 strategies, respectively, in vaccine-naïve adults aged ≥ 65 years. The estimated ICERs were cost saving in both regimens (i.e., V116 vs. PCV20 or vs. PCV15 + PPSV23). The scenario analysis and deterministic and probabilistic sensitivity analyses also demonstrated the robustness of the qualitative results.</p><p><strong>Conclusions: </strong>These results demonstrated that using V116 in adults aged ≥ 65 years in the US can prevent a substantial number of PD cases and deaths while remaining highly favorable economically over a wide range of inputs and scenarios.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2597-2615"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582112/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604351","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":"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":"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":" ","pages":"2475-2488"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582110/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"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":" ","pages":"2509-2526"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582274/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance of Drug-Drug Interactions with Nirmatrelvir/Ritonavir.","authors":"Victoria Hendrick, Erast Pohorylo, Lubna Merchant, Jackie Gerhart, Iqra Naz Arham, Florin Draica, Romina Quercia, Ayman Ayoub, Reema Mehta","doi":"10.1007/s40121-024-01050-w","DOIUrl":"10.1007/s40121-024-01050-w","url":null,"abstract":"<p><strong>Introduction: </strong>Nirmatrelvir/ritonavir (NMV/r) is approved in the United States (US) and more than 70 other countries for the treatment of mild to moderate COVID-19 in nonhospitalized adults at high risk for severe disease. Because ritonavir inhibits several drug metabolizing enzymes, potential drug-drug interactions (DDIs) between ritonavir and concomitant medications are an important consideration for prescribers. Here, we conducted a real-world analysis of data from Pfizer's global safety database regarding adverse events (AEs) reported during use of NMV/r concomitantly with potentially interacting drugs.</p><p><strong>Methods: </strong>Data were extracted regarding DDI cases occurring from the start of NMV/r authorization through October 31, 2023. Results regarding concomitant treatment, specific AEs, and clinical outcomes are summarized. Overall NMV/r exposure was estimated based on packs of medication dispensed and was used to calculate reporting rates.</p><p><strong>Results: </strong>Among 19,617,670 patients exposed globally to NMV/r, 966 cases of potential DDIs were reported. Of these, 594 occurred in the US against an estimated US exposure of 14,646,990 patients, representing a reporting rate of 0.004%. Globally and in the United States, 66.8% and 77.3% of cases, respectively, were nonserious. Simvastatin and tacrolimus were the most frequently reported drugs associated with potential DDIs, and the most frequently reported AE regarding a specific event or symptom was dysgeusia (altered sense of taste), an AE known to be associated with NMV/r.</p><p><strong>Conclusions: </strong>Low reporting rates of DDIs support the potential for NMV/r treatment to be safely managed with careful use of available drug interaction resources to aid in risk mitigation.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2545-2561"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499636","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":"Life After Invasive Meningococcal Disease: Insights from Survivors and Their Caregivers.","authors":"Oscar Herrera-Restrepo, Nuzhat Afroz, Eliazar Sabater Cabrera, Matthew Reaney, France Ginchereau Sowell, Ramiya Kumar, Alicia Stillman, Patti Wukovits, Mariana Rodrigues, Sofia B Pinto, Zeki Kocaata, Obinna Onwude","doi":"10.1007/s40121-024-01060-8","DOIUrl":"10.1007/s40121-024-01060-8","url":null,"abstract":"<p><strong>Introduction: </strong>Invasive meningococcal disease (IMD) has a low incidence but is a life-threatening illness that is preventable via vaccination. Even with treatment, up to 10-15% of cases are fatal, and many survivors may experience severe long-term sequelae. Building upon the acute-phase findings presented in the Part 1 manuscript for this study, we describe the long-term physical, social, psychological, and economic burden of IMD on US survivors and their caregivers in this Part 2 manuscript.</p><p><strong>Methods: </strong>This was a novel, non-interventional, mixed-methods study among US survivors and their caregivers using a bespoke survey and qualitative interviews.</p><p><strong>Results: </strong>Ten adult survivors, one adolescent survivor, and three caregivers participated in this study. Survivors described extensive physical, neurological, and systemic sequelae, including difficulty walking (11/11), repeat secondary infections (9/11), and numbness (6/11), among others, which were echoed by caregivers. Survivors shared that IMD had negatively impacted their long-term quality of life, citing long-term impacts including emotional impacts (11/11), social impacts (10/11), memory (7/11) and attention (5/11) problems, and difficulty with functional (10/11), self-care (7/11), and physical (6/11) activities. Caregivers were also impacted, describing emotional trauma (3/3), sleep problems (2/3), and day-to-day challenges (2/3). Long-term financial challenges related to healthcare resource utilization were substantial, with specialized care and rehabilitation therapy expenses (11/11), insurance challenges (8/11), and high out-of-pocket costs (6/11) for survivors. Productivity losses were also commonly described by survivors (9/11); sequelae hindered ability to attend school (9/11) or work full time (8/11). Caregivers (2/3) described taking leave from their employment, affecting family income.</p><p><strong>Conclusions: </strong>The humanistic burden of IMD on survivors and their caregivers is substantial and persistent. A comprehensive approach, including preventative measures (e.g., vaccination) and long-term medical, psychological, and financial support for those affected, is needed to mitigate the burden of IMD. A video abstract is available with this article. Video abstract (MP4 1,17,430 kb).</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2563-2579"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521844","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":"Global Epidemiology of Meningococcal Disease-Causing Serogroups Before and After the COVID-19 Pandemic: A Narrative Review.","authors":"Steven Shen, Jamie Findlow, Paula Peyrani","doi":"10.1007/s40121-024-01063-5","DOIUrl":"10.1007/s40121-024-01063-5","url":null,"abstract":"<p><p>Invasive meningococcal disease (IMD) is associated with high morbidity and mortality and predominantly caused by five Neisseria meningitidis serogroups (A/B/C/W/Y). Polysaccharide conjugate vaccines induce T-cell-dependent immune responses, are immunogenic in infants and adults, and reduce carriage, and vaccination of age groups associated with high-carriage can provide indirect protection in the unvaccinated (herd immunity). Successful vaccination programs must be tailored to local epidemiology, which varies geographically, temporally, and by age and serogroup. Serogroup A IMD once predominated globally, but has largely disappeared following mass vaccination programs. Serogroup B was a predominant cause of IMD in many global regions from 2010 to 2018, typically affecting younger age groups. Spread of serogroup C clonal complex-11 IMD in the 1990s prompted implementation of MenC vaccine programs in many countries, resulting in declines in prevalence. Serogroup C still caused > 20% of global IMD through the mid-2010s. Serogroup W became a significant contributor to global IMD after Hajj pilgrimage outbreaks in 2000; subsequent increases of endemic disease and outbreaks were reported pre-pandemic in many regions. Serogroup Y emerged in the 1990s as a significant cause of IMD throughout various regions and prevalence had increased or stabilized from 2010 to 2018. Serogroup X is uncommon outside the African meningitis belt, and its prevalence has declined since before the COVID-19 pandemic. Global IMD declines during the pandemic were followed by resurgences generally caused by serogroups that were prevalent pre-pandemic and affecting mainly unvaccinated age groups (particularly adolescents/young adults). Recent IMD epidemiology underscores the importance of vaccinating at-risk age groups against regionally prevalent serogroups; for example, the anti-serogroup X component of the recently prequalified MenACWXY vaccine is likely to provide limited protection outside the African meningitis belt. In other regions, comprehensive vaccination against MenB and MenACWY, which could be streamlined by the recently approved MenABCWY vaccine, seems more appropriate.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2489-2507"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582116/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604354","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":"Heartfelt Impact: A Descriptive Analysis of Ceftaroline-Containing Regimens in Endocarditis due to Methicillin-Resistant Staphylococcus aureus.","authors":"Kaylee E Caniff, Chloe Judd, Kristen Lucas, Sandra Goro, Caroline Orzol, Mirna Eshaya, Mohammed Al Musawa, Michael P Veve, Michael J Rybak","doi":"10.1007/s40121-024-01068-0","DOIUrl":"10.1007/s40121-024-01068-0","url":null,"abstract":"<p><strong>Introduction: </strong>Infective endocarditis (IE) due to methicillin-resistant Staphylococcus aureus (MRSA) is characterized by frequent treatment failure to first-line agents and high mortality, necessitating use of alternative management strategies. Ceftaroline fosamil (CPT) is a cephalosporin antibiotic with activity against MRSA but without regulatory approval for the indication of IE. This study describes clinical experience with CPT-based regimens utilized in MRSA-IE.</p><p><strong>Methods: </strong>This is a retrospective, observational, descriptive analysis of patients from two major urban medical centers in Detroit, Michigan from 2011 to 2023. Included adult patients (≥ 18 years) had ≥ 1 positive blood culture for MRSA, met definitive clinical criteria for IE, and received CPT for ≥ 72 h. The primary outcome was treatment failure, defined as a composite of 30-day all-cause mortality from index culture or failure to improve or resolve infectious signs/symptoms after CPT initiation.</p><p><strong>Results: </strong>Seventy patients were included. The median (interquartile range [IQR]) age was 51 (34-63) years and 45.7% were male. Persons with injection drug use (PWID) made up 55.7% of the cohort and right-sided IE was the most prevalent subtype (50.0%). CPT was frequently employed second-line or later, often in combination with vancomycin (10.0%) or daptomycin (72.9%). Overall, 31.4% experienced treatment failure and 30-day all-cause mortality occurred in 15.7%.</p><p><strong>Conclusions: </strong>These findings illustrate the challenges posed by MRSA-IE, including frequent treatment failures, and highlight the utilization of CPT as salvage therapy. Comparative studies are needed to more clearly define its role in MRSA-IE.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2649-2662"},"PeriodicalIF":4.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564402","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":"Acute Infusion-Related Side Effects of Amphotericin B Lipid Complex (ABLC) in Oncohematological Patients: Real-World Data from Brazilian Reference Centers.","authors":"Francelise Bridi Cavassin, Marcello Mihailenko Chaves Magri, Ariela Victoria Borgmann, Isabela Dombeck Floriani, Marina Rachid Barreto, Tania Zaleski, Fabianne Altruda de Moraes Costa Carlesse, Giovanni Luís Breda, Fábio de Araújo Motta, Diego Rodrigues Falci, Ana Verena Almeida Mendes, Hugo Paz Morales, Patrícia Silva Montes, Mariane Taborda, Talita Teles Teixeira Pereira, João Luiz Baú-Carneiro, Flávio Queiroz-Telles","doi":"10.1007/s40121-024-01086-y","DOIUrl":"https://doi.org/10.1007/s40121-024-01086-y","url":null,"abstract":"<p><strong>Introduction: </strong>Amphotericin B lipid complex (ABLC) is an effective antifungal agent for treating invasive fungal infections (IFIs) even though its formulation is associated with potential adverse events, including those related to its infusion. This study aimed to analyze the incidence of acute infusion-related side effects (IRSE) associated with ABLC and their relationship with the profile of patients with oncohematological disease admitted in Brazilian reference tertiary hospitals.</p><p><strong>Methods: </strong>This is an observational retrospective study that included clinical records of patients hospitalized, in a period of 6 years, diagnosed with probable or proved IFI and treated with at least two doses of ABLC.</p><p><strong>Results: </strong>A total of 229 patients were included, with a male prevalence and an average age of 44 years for adults and 10 years for children. Seventy-nine (34.5%) developed some IRSE, 5.1% of which progressed in severe form to discontinuation of treatment. The most prevalent events in adults were fever (66.7%), tremor/chills (53.3%), and tachycardia (24.4%). In children, the most common were fever (64.7%), tremors/chills (50%), and skin rash/itching (17.6%). Statistical significance was found for premedication use from the first dose of ABLC in relation to the onset of infusion reactions (P = 0.006). Multivariate analysis revealed that ABLC, when compared to liposomal AMB (L-AMB), and neutropenia were associated with a higher risk of developing IRSE (odds ratio [OR] 3.04, P = 0.008; and OR 11.02, P = 0.025, respectively).</p><p><strong>Conclusions: </strong>The use of premedication was a protective factor against the occurrence of IRSE. Therefore, services providing amphotericin B (AMB) must reinforce protocols or implement new measures that optimize tolerability and safety during the treatment of patients with oncohematological disease, with special attention to patients with neutropenia, prioritizing the liposomal formulation of AMB whenever possible.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768105","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":"Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial.","authors":"Barbara Rossetti, Micol Ferrara, Lucia Taramasso, Francesca Bai, Francesca Lombardi, Nicoletta Ciccarelli, Miriam Durante, Francesca Alladio, Federica Bonazza, Ilaria Rancan, Francesca Montagnani, Antonio Di Biagio, Antonella d'Arminio Monforte, Maurizio Zazzi, Massimiliano Fabbiani","doi":"10.1007/s40121-024-01083-1","DOIUrl":"https://doi.org/10.1007/s40121-024-01083-1","url":null,"abstract":"<p><strong>Introduction: </strong>Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC).</p><p><strong>Methods: </strong>DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for > 6 months and with HIV-RNA < 50 cps/ml for > 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus.</p><p><strong>Results: </strong>A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom.</p><p><strong>Conclusions: </strong>Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750721","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}