Liuyang Kang, Mingwei Wei, Hui Jiang, Xia Zang, Yu Pan, Youcai An, Jing Yang, Siyu Tian, Hang Tao, Hongxing Pan, Hui Jin
{"title":"Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China: A Phase IV Study.","authors":"Liuyang Kang, Mingwei Wei, Hui Jiang, Xia Zang, Yu Pan, Youcai An, Jing Yang, Siyu Tian, Hang Tao, Hongxing Pan, Hui Jin","doi":"10.1007/s40121-026-01439-9","DOIUrl":"10.1007/s40121-026-01439-9","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this work is to preliminarily evaluate the post-marketing safety of a quadrivalent subunit influenza vaccine in healthy individuals aged 3 years and above through active surveillance of adverse reactions following vaccination.</p><p><strong>Methods: </strong>During the 2024-2025 influenza season, healthy participants aged 3 years and older were enrolled in Jiangsu Province. All participants received a single dose of the quadrivalent subunit influenza vaccine. Adverse events (AEs) and serious adverse events (SAEs) were monitored within 0-28 days post-vaccination, and information on SAEs occurring within 6 months post-vaccination was also collected. Descriptive analyses were performed to calculate the reporting rates of AEs, adverse drug reactions (ADRs) and SAEs. We compared differences in overall and symptom-specific ADR reporting rates across age groups and sexes.</p><p><strong>Results: </strong>A total of 3105 participants completed vaccination and were included in the safety analysis set. A total of 282 participants reported 477 AEs, yielding an overall AE reporting rate of 9.08%. A total of 188 participants reported 318 ADRs, with an ADR reporting rate of 6.05%. The most frequently reported ADR symptoms were tenderness (69 episodes, reporting rate 2.22%), cough (57 episodes, 1.83%), and fever (46 episodes, 1.48%). The majority of ADRs (272 episodes, 85.53%) were grade 1 in severity, and most symptoms (253 episodes, 79.56%) resolved within 3 days of onset. No vaccine-related SAEs were reported, and no new serious adverse reactions were identified.</p><p><strong>Conclusions: </strong>This active surveillance study demonstrated a favorable safety profile for the quadrivalent subunit influenza vaccine, with low ADR reporting rates and predominantly mild, transient reactions. These findings provide reliable evidence supporting the preliminary post-marketing safety assessment of the vaccine in China.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3085-3100"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955393","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}
Adel S Alharbi, Nada Abu-Shraie, Hana Al Abdulkarim, Ibtisam H Alharbi, Ahuva Averin, Amy W Law, Diana Mendes, Erin Quinn, Mostafa Zayed, Ayman Behiry, Hammam Haridy, Mostafa Mousa
{"title":"Budget Impact of Strategies Involving RSVpreF and Nirsevimab to Protect Infants in Saudi Arabia Against Respiratory Syncytial Virus.","authors":"Adel S Alharbi, Nada Abu-Shraie, Hana Al Abdulkarim, Ibtisam H Alharbi, Ahuva Averin, Amy W Law, Diana Mendes, Erin Quinn, Mostafa Zayed, Ayman Behiry, Hammam Haridy, Mostafa Mousa","doi":"10.1007/s40121-026-01386-5","DOIUrl":"10.1007/s40121-026-01386-5","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory syncytial virus (RSV) manifesting as lower respiratory tract illness (LRTI; RSV-LRTI) has a significant clinical and economic impact for infants in the Kingdom of Saudi Arabia (KSA) and globally. We evaluated the budget impact (BI) of strategies involving maternal vaccine (RSVpreF) and single-dose monoclonal antibody (nirsevimab) to protect KSA infants against RSV-LRTI.</p><p><strong>Methods: </strong>A deterministic cohort model evaluated the clinical and economic burden of RSV-LRTI and the impact of interventions among five annual birth cohorts of infants aged < 1 year. Parameter values were estimated on the basis of published sources using KSA-specific data to the extent possible. Model outcomes included RSV-LRTI episodes (hospital, emergency department [ED], primary care [PC]), disease-attributable deaths, medical care costs, and intervention costs (in US$). Nirsevimab alone (herein \"Nirs\"; price: $1005.78; uptake: 90%) and, alternatively, mixed approach RSVpreF (price: $217.07; uptake: 14.3%) with nirsevimab (uptake: 90%) for unprotected infants (\"MV + Nirs\") were compared against no intervention (\"NoInt\").</p><p><strong>Results: </strong>NoInt would yield 2,115,924 cases (hospital: 85,898, ED: 943,770, PC: 1,086,255) and $817.9 million in medical care costs. Nirs would prevent 1,206,819 cases and $470.1 million in medical care costs; with $2054.3 million in intervention costs, BI would be $1.6 billion. Compared with NoInt, MV + Nirs would prevent 1,143,754 cases and $457.1 million in medical care costs; with $1851.6 million in intervention costs (MV: $78.6, Nirs: $1773.0), BI would be $1.4 billion.</p><p><strong>Conclusions: </strong>Findings suggest that either strategy would substantially reduce the burden of RSV-LRTI. Even with low uptake, adding RSVpreF (mixed approach) yielded considerably lower budget impact compared with nirsevimab alone.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2939-2952"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148264306","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}
Emmanuel Pio Pastore, Daniele Roberto Giacobbe, Antonio Vena, Matteo Bassetti
{"title":"Early Prediction of Carbapenem Resistance in Gram-Negative Organisms at Culture Ordering from Routinely Collected Hospital Data: Temporal and External Validation of ORDER-CARB.","authors":"Emmanuel Pio Pastore, Daniele Roberto Giacobbe, Antonio Vena, Matteo Bassetti","doi":"10.1007/s40121-026-01441-1","DOIUrl":"10.1007/s40121-026-01441-1","url":null,"abstract":"<p><strong>Introduction: </strong>Empirical therapy for severe suspected infection is selected before organism identification and antimicrobial susceptibility results are available. ORDER-CARB estimates, at culture ordering, the probability of subsequent recovery of a carbapenem-resistant Gram-negative organism using routinely collected structured data available before the index culture.</p><p><strong>Methods: </strong>ORDER-CARB was developed using a large publicly available dataset, the Antibiotic Resistance Microbiology Dataset, with chronological model-fitting, calibration, and temporal-test splits. The frozen model was transported to the independent and also publicly available East Carolina University Health (ECUH) and University of Texas Southwestern (UTSW) cohorts, locally recalibrated using older data, and evaluated in future hold-outs. The primary analysis included microbiologically labeled urine, respiratory, and blood cultures that subsequently yielded at least one Gram-negative organism with interpretable carbapenem susceptibility. A secondary two-stage analysis evaluated all blood-culture episodes in the external cohorts.</p><p><strong>Results: </strong>ORDER-CARB identified subsequent carbapenem-resistant Gram-negative isolates with an AUROC of 0.858 in internal temporal testing and of 0.797 at ECUH and 0.876 at UTSW in future external cohorts. Using locally selected cutoffs intended to identify approximately 9 of 10 resistant isolates and thereby prompt early review of whether empirical coverage against carbapenem-resistant Gram-negative organisms was warranted while susceptibility results were pending, sensitivity in the future cohorts was 91.6% at ECUH and 85.7% at UTSW. This approach would have prompted review in 55.4% and 27.7% of cultures, respectively, with positive predictive values of 5.7% and 9.4%. In the secondary analysis including all blood-culture episodes, irrespective of the subsequently identified organism, the model also showed high discrimination for carbapenem-resistant Gram-negative bloodstream infection, with AUROCs of 0.928 (95% CI 0.869-0.987) at ECUH and 0.967 (95% CI 0.909-1.000) at UTSW.</p><p><strong>Conclusions: </strong>ORDER-CARB retained useful ranking after chronological external transport, but the marked prevalence shift materially affected positive predictive value and review burden, and operating thresholds remained site-specific. The score should not replace susceptibility testing, severity assessment, or clinical judgment. Prospective evaluation is needed to determine whether it can support empiric treatment and stewardship decisions after local recalibration.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3151-3167"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989893","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}
Laurent Coudeville, Musallam Abuhasan, Abrar Alasmari, Anas Khan, Saber Yezli, Refaat Abdelaziz, Florence Coste, Alp Dogu, Angie Upegui, George Wahba, Abdullah Assiri
{"title":"Mass Gatherings as Amplifiers of Meningococcal Disease: A Modeling Study of Hajj and Umrah.","authors":"Laurent Coudeville, Musallam Abuhasan, Abrar Alasmari, Anas Khan, Saber Yezli, Refaat Abdelaziz, Florence Coste, Alp Dogu, Angie Upegui, George Wahba, Abdullah Assiri","doi":"10.1007/s40121-026-01427-z","DOIUrl":"10.1007/s40121-026-01427-z","url":null,"abstract":"<p><strong>Introduction: </strong>The Kingdom of Saudi Arabia (KSA) hosts millions of Hajj and Umrah pilgrims annually, and it aims to welcome 30 million external (international) Umrah pilgrims annually by 2030 (Saudi Vision 2030). These mass gatherings pose significant risks for infectious disease transmission. We extended a previous meta-population model of Neisseria meningitidis transmission during Hajj to include Umrah pilgrimage and assessed the impact of varying vaccination coverage rates (VCRs) among pilgrims on meningococcal meningitis (MM) cases.</p><p><strong>Methods: </strong>The model population was divided into five clusters: residents of the pilgrimage sites (Makkah/Madinah); the broader KSA population; and non-KSA populations from high-, medium-, and low-transmission settings. The model incorporated age, pilgrim movement patterns, and VCRs. The model was calibrated with data from 1995 to 2011 and validated with data from 2012 to 2024. MM cases under various vaccination and pilgrim scenarios were simulated for the 2025-2034 period.</p><p><strong>Results: </strong>Umrah accounted for approximately 90% of pilgrimage days in 2023-2024, with external pilgrims accounting for > 90% of these days. In a scenario where external pilgrim numbers increased in line with Saudi Vision 2030, the probability of an annual number of MM cases exceeding 100 among pilgrims during the 2025-2034 period was estimated at 53% with a 10% VCR among internal (domestic) and external Umrah pilgrims versus < 0.02% if both VCRs were 90%. High VCRs (90%) for external and internal pilgrims reduced the number of expected MM cases across the KSA by > 80% compared with no vaccination.</p><p><strong>Conclusion: </strong>Our analysis highlights the amplifying effect of mass gatherings on disease transmission dynamics and confirms vaccination as a highly effective intervention. Strengthened enforcement of meningococcal ACWY vaccination requirements for all Umrah pilgrims would significantly reduce MM outbreak risk and benefit the entire KSA population, as well as the pilgrims and people in their countries of origin.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2957-2975"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658743/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148850495","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":"Dengue Vodcast: Insights from Recent Infectious Disease Congresses.","authors":"Marco Aurélio P Sáfadi","doi":"10.1007/s40121-026-01428-y","DOIUrl":"10.1007/s40121-026-01428-y","url":null,"abstract":"<p><p>Dengue is the most common vector-borne viral disease. Dengue virus belongs to the Flaviviridae family, and it is predominantly transmitted by Aedes aegypti and Aedes albopictus mosquitoes. Dengue is a global threat to public health, with hundreds of millions of infections each year. Not only is the incidence of dengue increasing, but the geographic areas at risk are also expanding, with outbreaks in areas that have never reported dengue cases in the past, such as North America and Europe. In this vodcast, Professor Marco Aurélio Sáfadi, a pediatric infectious diseases specialist and associate professor at Santa Casa de São Paulo, Brazil, discusses key highlights of current dengue research from selected congresses held in 2025-the World Congress of the World Society for Pediatric Infectious Diseases, the American Society of Tropical Medicine and Hygiene, and the Latin American Congress of Pediatric Infectious Disease. The aim of the vodcast is to communicate the latest scientific findings and provide insights into their clinical significance. The vodcast covers a wide range of topics relating to dengue, including vaccination, surveillance and control, prophylaxis, diagnosis, management, predicting disease progression, and immune responses during dengue infection. Data from these congresses highlight the key role dengue vaccines play in disease prevention, and how vector control methods, like Wolbachia, can help reduce the spread of the disease. They also highlight the need for an integrated approach to targeting dengue, bringing together advanced diagnostic and prognostic tools, vector control techniques, and novel therapeutic and disease management strategies.Vodcast available for this article. Podcast Audio (MP4 1271498 KB).</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2927-2938"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955868","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}
Areum Hwang, Hyeontaek Hwang, Dong-Hyun Joo, Ye Jin Lee, Byoung Soo Kwon, Yeon Wook Kim, Jong Sun Park, Nakwon Kwak, Jae-Joon Yim, Hyung-Jun Kim, Jae Ho Lee
{"title":"Immediate Treatment Versus Watchful Waiting in Mycobacterium avium Complex Pulmonary Disease: A Propensity Score Matched Analysis.","authors":"Areum Hwang, Hyeontaek Hwang, Dong-Hyun Joo, Ye Jin Lee, Byoung Soo Kwon, Yeon Wook Kim, Jong Sun Park, Nakwon Kwak, Jae-Joon Yim, Hyung-Jun Kim, Jae Ho Lee","doi":"10.1007/s40121-026-01433-1","DOIUrl":"10.1007/s40121-026-01433-1","url":null,"abstract":"<p><strong>Introduction: </strong>The optimal timing for initiating antibiotic therapy in Mycobacterium avium complex pulmonary disease (MAC-PD) remains controversial. While previous studies advocate for \"watchful waiting\" in some cases, specific criteria to prioritize immediate treatment over observation are not well defined.</p><p><strong>Methods: </strong>We retrospectively analyzed 592 treatment-naïve patients with MAC-PD diagnosed between 2003 and 2021. Propensity score matching was used to balance baseline characteristics between patients receiving immediate treatment (initiated ≤ 2 months [60 days] of diagnosis) and those undergoing watchful waiting. Primary outcomes were all-cause and respiratory mortality; secondary outcomes included culture conversion and adverse events.</p><p><strong>Results: </strong>After matching, 102 pairs were analyzed. Immediate treatment was associated with significantly faster culture conversion [hazard ratio (HR) 3.07; 95% CI 1.68-5.61] but a higher incidence of adverse events (64.7% vs. 41.2%; P = 0.001). In the overall matched population, immediate treatment did not improve all-cause (HR 0.92; 95% CI 0.53-1.61) or respiratory mortality (HR 0.47; 95% CI 0.19-1.14). However, in the subgroup of patients with moderate-to-severe disease (BACES score ≥ 2), immediate treatment was significantly associated with reduced all-cause (HR 0.53; 95% CI 0.30-0.96) and respiratory mortality (HR 0.35; 95% CI 0.14-0.90).</p><p><strong>Conclusions: </strong>Immediate treatment accelerates culture conversion but increases AEs without improving overall survival, supporting watchful waiting for mild cases. However, patients with a BACES score ≥ 2 derive significant survival benefit from immediate therapy, suggesting the BACES score is an effective tool for guiding treatment timing. Regardless of the initial treatment decision, close and regular monitoring remains essential, as some patients will ultimately require treatment.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3057-3071"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658716/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148906096","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-Associated Pancreatic Injury: a Spectrum from Mild Interstitial to Recrudescent Pancreatitis with Pharmacovigilance Implications.","authors":"Guanghui Chen, Qiang Qu, Lishan Yi, Yanyan Zhou, Jian Qu","doi":"10.1007/s40121-026-01443-z","DOIUrl":"10.1007/s40121-026-01443-z","url":null,"abstract":"<p><strong>Introduction: </strong>Omadacycline is a novel aminomethylcycline antibiotic with an incompletely characterized safety profile, particularly regarding pancreatic toxicity. A single case of omadacycline-induced acute pancreatitis has been reported, yet multiple FDA Adverse Event Reporting System (FAERS) analyses have failed to detect a pancreatitis signal. We aimed to characterize the spectrum of omadacycline-associated pancreatic injury and to explore the pharmacovigilance implications of cases presenting with subtle or atypical imaging features.</p><p><strong>Methods: </strong>We report three cases from an intensive care unit in which patients developed pancreatic enzyme elevation (> 3 × ULN) temporally associated with omadacycline. Alternative etiologies were systematically excluded. Causality was assessed using the Naranjo scale. A literature search of PubMed and Embase was also performed.</p><p><strong>Results: </strong>All three patients exhibited predominant hyperlipasemia with CT-confirmed pancreatic injury spanning a severity spectrum. Case 1 (79F) showed lipase > 34 × ULN, peritoneal signs, and new pancreatic head enlargement with peripancreatic stranding (Naranjo 7); Case 2 (18M) had asymptomatic lipase elevation with diffuse glandular swelling and heterogeneous parenchymal density (Naranjo 5); Case 3 (73F) developed recrudescent focal pancreatitis during continued exposure, with tail involvement and perirenal fascial thickening (Naranjo 4). All improved after discontinuation. Common etiologies were excluded. The previously reported case showed an inverse pattern (imaging-dominant with mild enzyme elevation). Collectively, these four cases support upgrading omadacycline from Badalov Class IV to Class III.</p><p><strong>Conclusions: </strong>Omadacycline can cause a spectrum of pancreatic injury, from mild interstitial pancreatitis to recrudescent disease, with CT findings that may be unobtrusive and easily overlooked. This underrecognition likely contributes to underreporting, which may explain the absence of a FAERS pancreatitis signal. Clinicians should monitor lipase and amylase, maintain a low threshold for CT imaging when enzymes rise, and report suspected cases using specific MedDRA terms.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3211-3220"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148968116","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}
Sean P Fleming, Kyung Min Lee, Girish Prajapati, Wenying Quan, Kyle Roney, Shweta Kamat, Milena Murray, Samira Saad, Viktor Chirikov, Princy N Kumar
{"title":"Prevalence and Severity of Potential Drug-Drug Interactions in People Living with HIV on Antiretroviral Therapy in the United States.","authors":"Sean P Fleming, Kyung Min Lee, Girish Prajapati, Wenying Quan, Kyle Roney, Shweta Kamat, Milena Murray, Samira Saad, Viktor Chirikov, Princy N Kumar","doi":"10.1007/s40121-026-01435-z","DOIUrl":"10.1007/s40121-026-01435-z","url":null,"abstract":"<p><strong>Introduction: </strong>As people living with HIV (PLWH) age, the risk for polypharmacy and potential drug-drug interactions (pDDIs) will likely increase, which may pose clinical challenges and contribute to increased healthcare burden.</p><p><strong>Methods: </strong>This retrospective study used administrative claims data (1/1/19-1/31/25) from Optum's de-identified Clinformatics® Data Mart Database and included adults with ≥ 1 antiretroviral therapy (ART) claim from 1/1/24-12/31/24 (index date: earliest ART claim). The prevalence and severity of pDDIs between ART and each non-ART comedication the PLWH received during the 30-day post-index period were quantified at the ART agent and ART regimen levels. DDI severity was categorized using the University of Liverpool HIV Drug Interactions Resource scale: contraindicated, major, minor, or no interaction. Prevalence of pDDIs was reported as the proportion of PLWH with any pDDI by severity category.</p><p><strong>Results: </strong>Overall, 22,412 PLWH were included; 44.2% had ≥ 1 pDDI classified as contraindicated, major, or minor. At the ART regimen level, contraindicated pDDIs were most prevalent for darunavir/cobicistat/emtricitabine/tenofovir alafenamide (14.4%) and elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (14.0%). Major pDDIs were observed in up to 66.4% of PLWH receiving certain boosted ART, whereas contraindicated pDDIs were uncommon (< 7%) among PLWH on non-boosted integrase inhibitor- and non-nucleoside reverse transcriptase inhibitor-based regimens. Across commonly prescribed ART regimens, 61.5% to 69.7% of PLWH had either no comedications or only comedications classified as having no interaction, with lower proportions observed for boosted regimens, and major pDDIs were predominantly associated with antidiabetic medications and statins.</p><p><strong>Conclusions: </strong>In this large, real-world claims analysis, pDDIs between ART and non-ART medications were not uncommon in routine clinical practice. As the HIV population continues to age, systematic screening for drug interactions (particularly with comedications for chronic conditions such as diabetes and cardiovascular disease) and thoughtful, individualized ART selection may help mitigate interaction risk and support safe, effective long-term HIV management.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3073-3084"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955487","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}
Jeffrey T Vietri, Sophie A Warren, Matthew J Heffler
{"title":"Practical Considerations Shaping Pneumococcal Vaccine Selection: A Multinational Cross-Sectional Survey of Healthcare Professionals.","authors":"Jeffrey T Vietri, Sophie A Warren, Matthew J Heffler","doi":"10.1007/s40121-026-01436-y","DOIUrl":"10.1007/s40121-026-01436-y","url":null,"abstract":"<p><strong>Introduction: </strong>The pneumococcal vaccine landscape now includes multiple vaccines differing in age indications and serotype compositions. While clinical attributes such as effectiveness, safety, and disease coverage are key considerations, healthcare professionals (HCPs) also confront operational aspects of vaccination, such as managing multiple vaccines across pediatric and adult populations which are less well characterized. This study assessed HCP priorities and practical considerations for pneumococcal vaccine selection and the additional serotype coverage required to justify use of an adult-specific vaccine instead of the same vaccine across children and adults.</p><p><strong>Methods: </strong>This cross-sectional online survey involved 500 HCPs (physicians, nurses, and pharmacists) from Australia, Canada, France, Mexico, and Taiwan. The perceived importance of pneumococcal vaccination, practical considerations, perceived challenges and benefits of using a single vaccine across age groups versus separate age-specific vaccines, and the serotype coverage difference to justify use of multiple pneumococcal vaccines strategies were assessed.</p><p><strong>Results: </strong>Pneumococcal vaccination was rated as important by 97.6% of HCPs for children and 99.2% for adults. Implementation factors important to HCPs included logistical hurdles while ordering and stocking (94.0%) and minimal storage requirements (84.4%). Use of separate pediatric and adult vaccines was considered to increase refrigeration requirements (90.0% agreeing) and stock handling complexity (89.1%), whereas use of a common vaccine across age groups was perceived to provide cost savings at practice level (85.1%) and health system level (83.4%). HCPs also agreed that a single vaccine would reduce the potential for medical errors (96.3%) and improve inventory management (93.0%). An average difference of 34.7 ± 16.8% in adult-specific invasive pneumococcal disease serotype coverage was perceived by HCPs to justify adding an adult-specific vaccine rather than using a single vaccine across age groups.</p><p><strong>Conclusion: </strong>HCPs balance clinical attributes with real-world delivery constraints when selecting pneumococcal vaccines, and favor simpler, single-vaccine strategies across age groups unless separate vaccines offer a clearly substantial coverage advantage.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3003-3015"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148857404","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 Characteristics, Healthcare Utilization, and Treatment Patterns Among People Living with HIV by Antiretroviral Therapy Use in the USA, 2021-2024.","authors":"Moti Ramgopal, Jacob Lalezari, Carrie Huisingh, Yunhua Fan, Arlene Nugent, Chloe Orkin, Karine Dubé, Kimmie Pringle, Liza Bronner Murrison","doi":"10.1007/s40121-026-01424-2","DOIUrl":"10.1007/s40121-026-01424-2","url":null,"abstract":"<p><strong>Introduction: </strong>Despite advances in antiretroviral therapy (ART), real-world data remain limited regarding clinical characteristics and healthcare utilization according to ART use among people living with human immunodeficiency virus (PLWH), as well as patterns of ART use in this population.</p><p><strong>Methods: </strong>This retrospective cohort study used a US healthcare claims database to identify adult PLWH from 2021 to 2024. Primary cohort included those with ≥3 human immunodeficiency virus (HIV)-1 diagnosis codes within 3 years (third code defined the index date). A nested cohort included PLWH with ≥1 ART prescription claim(s) within 180 days of follow-up. All-cause and HIV-related inpatient hospitalizations and emergency room (ER) visits were assessed before and after index date. Pharmacotherapy change within 180 days after index was assessed for the nested cohort.</p><p><strong>Results: </strong>In the primary cohort of 51,837 PLWH, mean age was 46.5 years; 17.5% were women, and 57.1% resided in the southern USA. Notably, 6.5% had no observed ART claim (never ART), and 92.5% had an observed ART claim at some point (ever ART). The never ART group had significantly higher hospitalizations (8.3% versus 5.2%; P value < 0.0001) and ER visits (23.6% versus 17.5%; P value < 0.0001), and fewer other drug prescriptions (antidiabetics, 3.4% versus 9.8%; antihypertensives, 9.7% versus 34.5%; statins, 5.2% versus 23.7%; P value < 0.0001 each) versus the ever ART group. Among 35,591 PLWH prescribed ART, 2% were newly observed ART initiators with first-line ART and 98% were prevalent users. Newly observed ART initiators had higher rates of all-cause inpatient hospitalizations (63.7 versus 39.9 per 1000 person-years) versus prevalent users. Overall, 32.3% of PLWH discontinued their index ART regimen within 180 days and did not restart ART during the analysis period.</p><p><strong>Conclusions: </strong>Nearly one-third of PLWH discontinued their initial ART, and 6.5% were not on ART in the study period. PLWH without documented ART claims have greater healthcare utilization than those who received ART. Enhancing ART tolerability, dosing modalities, and convenience may improve treatment coverage and viral suppression outcomes, and reduce discontinuation rates.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"3017-3032"},"PeriodicalIF":5.6,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148887436","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}