Tesleem K. Babalola , Sean A.P. Clouston , Zennur Sekendiz , Devi Chowdhury , Nicola Soriolo , Joseph Kawuki , Jaymie Meliker , Melissa Carr , Bruno R. Valenti , Ashley Fontana , Onix A. Melendez , Olga Morozova , Benjamin J. Luft
{"title":"SARS-COV-2 re-infection and incidence of post-acute sequelae of COVID-19 (PASC) among essential workers in New York: a retrospective cohort study","authors":"Tesleem K. Babalola , Sean A.P. Clouston , Zennur Sekendiz , Devi Chowdhury , Nicola Soriolo , Joseph Kawuki , Jaymie Meliker , Melissa Carr , Bruno R. Valenti , Ashley Fontana , Onix A. Melendez , Olga Morozova , Benjamin J. Luft","doi":"10.1016/j.lana.2024.100984","DOIUrl":"10.1016/j.lana.2024.100984","url":null,"abstract":"<div><h3>Background</h3><div>After surviving Coronavirus Disease 2019 (COVID-19), some people develop symptoms known as post-acute sequelae of COVID-19 (PASC). PASC is an emerging phenomenon yet to be fully understood, and identifying risk factors has been challenging. This study investigated the association between the number of COVID-19 episodes and the incidence of PASC among essential workers.</div></div><div><h3>Methods</h3><div>We analyzed data from 2511 essential workers, mainly first responders, with confirmed polymerase chain reaction, antibody, or antigen-positive test results for SARS-CoV-2 infection from March 2020 to February 2024. Data were collected through in-person questionnaires and surveys sent via text and email, internal medical records, follow-up calls, and external medical records. Participants who reported continuation or the development of new symptoms three months after the initial SARS-CoV-2 infection, with symptoms lasting for at least two months, were categorized as having PASC, while those without any COVID-19 or whose symptoms resolved were classified as non-PASC. PASC was common in this cohort so we used a Poisson regression model to compute multivariable-adjusted Relative Risk (RR) for the association between risk of PASC and SARS-CoV-2 re-infection, severity, and vaccination status at first infection.</div></div><div><h3>Findings</h3><div>A total of 475 (prevalence = 18.9%, [95% confidence interval] = [17.4–20.5]) PASC patients were identified. The mean (standard deviation (SD)) age of participants who experienced PASC (54.8 (7.2) years) was similar to those who did not (54.2 (7.4) years). There were 403 (16.1% [14.6–17.5]) participants who experienced multiple instances of COVID-19. After adjusting for relevant demographic, lifestyle, and clinical variables, we found a significant association between the risk of experiencing PASC and multiple SARS-COV-2 infections (RR = 1.41 [1.14–1.74]), severe COVID-19 (RR = 3.17 [2.41–4.16]), and being unvaccinated at first infection (RR = 3.29 [2.46–4.41]).</div></div><div><h3>Interpretation</h3><div>Although the pathogenetic mechanism for PASC remains unclear, identifying risk factors such as lack of vaccination or re-infection can assist in better understanding and managing the condition.</div></div><div><h3>Funding</h3><div><span>National Institute on Aging</span> (NIH/NIA R01 AG049953) and <span>Centers for Disease Control and Prevention</span> (CDC/NIOSH U01 OH011864) and (CDC/NIOSH U01 OH012275).</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100984"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764319/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Flávia Nascimento de Carvalho , Marianna de Camargo Cancela , Luciano Mesentier da Costa , Luís Felipe Leite Martins , Fernando Luiz Dias , Dyego Leandro Bezerra de Souza , Luis Felipe Ribeiro Pinto
{"title":"Disparities in stage at diagnosis of head and neck tumours in Brazil: a comprehensive analysis of hospital-based cancer registries","authors":"Flávia Nascimento de Carvalho , Marianna de Camargo Cancela , Luciano Mesentier da Costa , Luís Felipe Leite Martins , Fernando Luiz Dias , Dyego Leandro Bezerra de Souza , Luis Felipe Ribeiro Pinto","doi":"10.1016/j.lana.2024.100986","DOIUrl":"10.1016/j.lana.2024.100986","url":null,"abstract":"<div><h3>Background</h3><div>The advanced stage of cancer is a determining factor in poor prognosis. Head and neck squamous cell carcinomas (HNSCC) are highly incident in Brazil, but similarly to many Low and Middle-Income Countries, data is limited regarding the proportion of tumours diagnosed at advanced clinical stages and the main factors associated with it. Therefore, this study aimed to identify the factors associated with advanced stage of HNSCC in Brazil.</div></div><div><h3>Methods</h3><div>Cross-sectional study based on secondary data collected from Hospital-based Cancer Registries (HBCR) between 2000 and 2017. Descriptive data analysis and Poisson regression with robust variance were performed to determine prevalence ratios (PRs).</div></div><div><h3>Findings</h3><div>Among 145,365 HNSCC cases, 78.2% (90,267/115,371) were diagnosed at stages III or IV. The highest percentage of advanced-stage tumours were hypopharyngeal [91.3% (10,186/11,159)], followed by oropharyngeal [86.6% (28,578/32,991)], oral cavity [75.1% (27,121/36,120)], and laryngeal cancer [69.5% (24,382/35,101)]. We observed annual increase trends of 0.29% and 0.38% for oral cavity and oropharyngeal late-stage tumours, respectively. Patients younger than 50 years old, with a low education level, presenting a primary tumour located in the hypopharynx or oropharynx, and alcohol and tobacco consumers were positively associated with advanced stage. Furthermore, we observed a dose–response effect of a statistically significant reduction in the prevalence of cases diagnosed in advanced stages as the patients' age group or education level increased.</div></div><div><h3>Interpretation</h3><div>Diagnosis of HNSCC at advanced clinical stages in Brazil was associated with age, primary tumour site, and socioeconomic factors that must be mitigated, allowing more universal and equitable access and diagnosis at earlier stages.</div></div><div><h3>Funding</h3><div>No funding.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100986"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773251/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mauro F.F. Mediano , Yejin Mok , Shoshana H. Ballew , Franklyn Gonzalez II , Daniela Sotres-Alvarez , Yasmin Mossavar-Rahmani , Robert Kaplan , Jordan A. Carlson , Sarah K. Alver , Martha Daviglus , Olga Garcia-Bedoya , Kelly R. Evenson , Jennifer A. Schrack , Kunihiro Matsushita
{"title":"The association of physical activity fragmentation with all-cause mortality in Hispanics: a prospective cohort study","authors":"Mauro F.F. Mediano , Yejin Mok , Shoshana H. Ballew , Franklyn Gonzalez II , Daniela Sotres-Alvarez , Yasmin Mossavar-Rahmani , Robert Kaplan , Jordan A. Carlson , Sarah K. Alver , Martha Daviglus , Olga Garcia-Bedoya , Kelly R. Evenson , Jennifer A. Schrack , Kunihiro Matsushita","doi":"10.1016/j.lana.2025.100996","DOIUrl":"10.1016/j.lana.2025.100996","url":null,"abstract":"<div><h3>Background</h3><div>Physical activity fragmentation represents the frequency of transitioning from an active to sedentary state. The prognostic information of physical activity fragmentation is unclear in Hispanics/Latinos. This study examined the association of PA fragmentation with all-cause mortality in Hispanic/Latino adults.</div></div><div><h3>Methods</h3><div>We investigated 11,992 participants from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) (18–74 yr; 52.2% women), from four United States urban communities (Bronx, New York; Chicago, Illinois; Miami, Florida; San Diego, California), that wore an accelerometer for one week. Physical activity fragmentation was calculated using the active-to-sedentary transition probability (ASTP) as the reciprocal of the average active bout duration. Daily total log-transformed activity count (TLAC) was used as a measure of total physical activity. The residual of ASTP regressed on TLAC (TLAC-adjusted ASTP) was explored to investigate the association of ASTP independent of total physical activity. Deaths were identified from annual follow-up interviews, obituary searches, or matches to the National Death Index through December 31, 2021. Cox regression models were fitted according to physical activity fragmentation.</div></div><div><h3>Findings</h3><div>There were 745 deaths (6.2%) over a mean follow-up of 11.2 (SD 2.2) years. The highest compared to the lowest tertile of ASTP showed a HR of 1.45 (95% CI 1.10–1.92) of all-cause mortality after accounting for confounders. The mortality risk also increased for each 0.10-unit increase of ASTP, as a continuous variable, by 22% (HR 1.22; 95% CI 1.07–1.39). The results were similar considering TLAC-adjusted ASTP.</div></div><div><h3>Interpretation</h3><div>Among Hispanic/Latino adults, more fragmented physical activity was associated with elevated all-cause mortality, independent of total physical activity volume.</div></div><div><h3>Funding</h3><div>HCHS/SOL was supported by the <span>National Institutes of Health</span>.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100996"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143141996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marcio Coutinho Xavier Naves , Angelica Amorim Amato , Ivan Ricardo Zimmermann , Henry Maia Peixoto
{"title":"Dapagliflozin for the treatment of heart failure with reduced ejection fraction in Brazil: a cost-effectiveness analysis","authors":"Marcio Coutinho Xavier Naves , Angelica Amorim Amato , Ivan Ricardo Zimmermann , Henry Maia Peixoto","doi":"10.1016/j.lana.2024.100968","DOIUrl":"10.1016/j.lana.2024.100968","url":null,"abstract":"<div><h3>Background</h3><div>Heart failure, a complex clinical syndrome with high morbidity and mortality, has become a significant burden on public health. Recently, a new class of antidiabetic agents–the sodium-glucose cotransporter 2 (SGLT2) inhibitors–was associated with a significant reduction on mortality and hospitalization in HF with reduced ejection fraction (HFrEF) when added to standard pharmacological treatment. Considering the lack of data on its cost-effectiveness, the present study aims to estimate the incremental cost-effectiveness ratio of add-on dapagliflozin treatment for HFrEF from the Brazilian public healthcare system perspective.</div></div><div><h3>Methods</h3><div>We built a Markov model to estimate the clinical outcomes and costs of 1,000 hypothetical subjects with established HFrEF in a lifetime horizon. The model inputs were based on the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial and local data. The main outcome was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained. Deterministic and probabilistic sensitivity analyses, as well as scenario analyses, were performed.</div></div><div><h3>Findings</h3><div>The addition of dapagliflozin to standard care treatment in 1,000 HFrEF patients yielded an expected value of 366.99 additional QALYs at an incremental cost of US$ 1,517,878.49, resulting in an ICER of US$ 4,136.08 per QALY gained, being a cost-effective strategy considering the Brazilian official cost-effectiveness threshold (US$ 8,000/QALY). In probabilistic sensitivity analyses, 96.60% of the simulations were also cost-effective. In the scenario analyses, results were similar for individuals with and without diabetes.</div></div><div><h3>Interpretation</h3><div>Dapagliflozin is likely to be cost-effective when added to standard HFrEF therapy in Brazil.</div></div><div><h3>Funding</h3><div>This study was supported by the <span>National Institute of Science and Technology</span> for Health Technology Assessment (Instituto de Avaliação de Tecnologias em Saúde—IATS).</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100968"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11742827/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhancing venous thromboembolism prevention in community oncology: a call for continued action","authors":"Xinyue Yang, Zhiqiang Zhang","doi":"10.1016/j.lana.2024.100978","DOIUrl":"10.1016/j.lana.2024.100978","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100978"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11732681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xuerong Wen, Todd Brothers, Kristina E. Ward, Stephen Kogut
{"title":"Reduction in chronic post-surgical opioid utilization in the USA: 2020–2022 vs. 2017–2019","authors":"Xuerong Wen, Todd Brothers, Kristina E. Ward, Stephen Kogut","doi":"10.1016/j.lana.2024.100977","DOIUrl":"10.1016/j.lana.2024.100977","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100977"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Philip Joseph , Fernando Lanas , Greg Roth , Patricio Lopez-Jaramillo , Eva Lonn , Victoria Miller , Andrew Mente , Darryl Leong , Jon-David Schwalm , Salim Yusuf
{"title":"Cardiovascular disease in the Americas: the epidemiology of cardiovascular disease and its risk factors","authors":"Philip Joseph , Fernando Lanas , Greg Roth , Patricio Lopez-Jaramillo , Eva Lonn , Victoria Miller , Andrew Mente , Darryl Leong , Jon-David Schwalm , Salim Yusuf","doi":"10.1016/j.lana.2024.100960","DOIUrl":"10.1016/j.lana.2024.100960","url":null,"abstract":"<div><div>This first article of the Series about Cardiovascular Disease in the Americas summarizes the epidemiology of CVD and its risk factors, and population-level strategies in place aimed at CVD prevention. While age-standardized CVD incidence and CV mortality rates have been decreasing across in the Americas since 1990, the annual number of CVD cases and related deaths have increased due to population growth and ageing. The burden of CVD is also slowly transitioning from high-income countries in North America to middle-income countries in Latin America and the Caribbean. Trends in CV risk factor levels have been mixed, with declines in smoking and mean cholesterol counterbalanced by higher prevalence of obesity and diabetes. Population-wide strategies aimed at controlling cardiometabolic risk factors and tobacco use have been implemented with varying degrees of success. There is a need to better implement existing CVD prevention strategies in the region.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"42 ","pages":"Article 100960"},"PeriodicalIF":7.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143402964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jingwen Li , Rachel E. Murray-Watson , Sancta B. St Cyr , Yonatan H. Grad , Joshua L. Warren , Reza Yaesoubi
{"title":"Association between city-level sociodemographic and health factors and the prevalence of antimicrobial-resistant gonorrhea in the US, 2000–2019: a spatial–temporal modeling study","authors":"Jingwen Li , Rachel E. Murray-Watson , Sancta B. St Cyr , Yonatan H. Grad , Joshua L. Warren , Reza Yaesoubi","doi":"10.1016/j.lana.2025.101006","DOIUrl":"10.1016/j.lana.2025.101006","url":null,"abstract":"<div><h3>Background</h3><div>Evidence from the surveillance systems of antimicrobial-resistant (AMR) gonorrhea suggests substantial variation in the prevalence of AMR gonorrhea across populations. However, little is known about the extent to which the population-level demographic, socioeconomic, and health factors (e.g., population density, poverty level, or the prevalence of other sexually-transmitted diseases) are associated with the burden of AMR gonorrhea. We developed a hierarchical Bayesian spatial–temporal logistic regression model to investigate the association between multiple spatially- and temporally-varying predictors and the proportion of isolates with resistance to each one of ciprofloxacin, penicillin, and tetracycline between 2000 and 2019 in the United States (US).</div></div><div><h3>Methods</h3><div>The model was informed by data from the Gonococcal Isolate Surveillance Project (GISP), a sentinel surveillance system to monitor trends in the AMR gonorrhea in the US. During our study period, GISP included 112,487 isolates from the first 25 symptomatic men who have been diagnosed with urethral gonorrhea each month after attending participating sexually-transmitted disease clinics in one of about 30 select cities.</div></div><div><h3>Findings</h3><div>Among 112,487 isolates collected between 2000 and 2019, 16.5%, 13.7%, and 22.2% were resistance to ciprofloxacin, penicillin, and tetracycline. Denser populations were associated with higher prevalence of ciprofloxacin and penicillin resistance (odd ratio (OR): 1.5, 95% with credible interval: [1.29, 1.74] and 1.36 [1.22, 1.52], respectively); West was associated with higher prevalence of ciprofloxacin resistance (OR with respect to Midwest: 14.42 [2.02, 59.27]) and Southeast was associated with higher prevalence of ciprofloxacin and penicillin resistance (OR with respect to Midwest: 6.66 [1.59, 18.20] and 7.59 [2.3, 22.94]); higher prevalence of HIV was associated with higher prevalence of ciprofloxacin and tetracycline resistance (OR: 1.18 [1.01, 1.37] and 1.14 [1.02, 1.28]); and higher incidence of gonorrhea was associated with higher prevalence of tetracycline resistance (OR: 1.08 [1.05, 1.11]).</div></div><div><h3>Interpretation</h3><div>Geographic location and certain population-level characteristics including population density and HIV prevalence could provide insight about the population-level risk of AMR gonorrhea at a county-level. These results could guide the expansion of AMR surveillance systems or access to drug susceptibility testing in areas with characteristics associated with increased prevalence of AMR gonorrhea.</div></div><div><h3>Funding</h3><div>US <span>National Institutes of Health</span>.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"43 ","pages":"Article 101006"},"PeriodicalIF":7.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143131554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura C. Antochevis , Camila M. Wilhelm , Beatriz Arns , Daniel Sganzerla , Letícia O. Sudbrack , Thais C.R.L. Nogueira , Ricardo D. Guzman , Amanda S. Martins , Daniela S. Cappa , Ândrea C. dos Santos , Joseani C. Pascual , Vitor Hugo Perugini , Eliana C. Vespero , Maria Helena P. Rigatto , Dariane C. Pereira , Larissa Lutz , Robson S. Leão , Elizabeth A. Marques , Danielle M. Henrique , André A.M. Coelho , Jailton Santos de Oliveira
{"title":"World Health Organization priority antimicrobial resistance in Enterobacterales, Acinetobacter baumannii, Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus faecium healthcare-associated bloodstream infections in Brazil (ASCENSION): a prospective, multicentre, observational study","authors":"Laura C. Antochevis , Camila M. Wilhelm , Beatriz Arns , Daniel Sganzerla , Letícia O. Sudbrack , Thais C.R.L. Nogueira , Ricardo D. Guzman , Amanda S. Martins , Daniela S. Cappa , Ândrea C. dos Santos , Joseani C. Pascual , Vitor Hugo Perugini , Eliana C. Vespero , Maria Helena P. Rigatto , Dariane C. Pereira , Larissa Lutz , Robson S. Leão , Elizabeth A. Marques , Danielle M. Henrique , André A.M. Coelho , Jailton Santos de Oliveira","doi":"10.1016/j.lana.2025.101004","DOIUrl":"10.1016/j.lana.2025.101004","url":null,"abstract":"<div><h3>Background</h3><div>Carbapenem-resistant <em>Enterobacterales</em> (CRE), <em>Acinetobacter baumannii</em> (CRAB), <em>Pseudomonas aeruginosa</em> (CRPA), methicillin-resistant <em>Staphylococcus aureus</em> (MRSA) and vancomycin-resistant <em>Enterococcus faecium</em> (VRE) are listed by World Health Organization (WHO) as priority antimicrobial-resistant bacteria. Data on WHO Priority Antimicrobial resistance Phenotype (WPAP) bacteria from low- and middle-income countries are scarce. In this study, we investigated the occurrence of WPAP in healthcare-associated bloodstream infections (BSI) in Brazil, an upper-middle-income country in South America.</div></div><div><h3>Methods</h3><div>ASCENSION was a prospective, multicentre, observational study conducted in 14 hospitals from four of five Brazilian regions. <em>Enterobacterales</em>, <em>A. baumannii</em>, <em>P. aeruginosa, S. aureus</em> and <em>E. faecium</em> BSIs in hospitalised patients were analysed. The primary outcome was the frequency of WPAP among all bacteria of interest. Secondary outcomes were incidence-density of bacteria isolates in hospitalised patients, WPAP proportions within bacterial species, and 28-day mortality. PCR for carbapenemase genes was performed in carbapenem-resistant Gram-negative bacteria.</div></div><div><h3>Findings</h3><div>Between August 15, 2022, and August 14, 2023, 1350 isolates (1220 BSI episodes) were included. WPAP accounted for 38.8% (n = 524; 95% Confidence Interval 32.0–46.1) of all isolates, with CRE (19.3%) as the most frequent, followed by CRAB (9.6%), MRSA (4.9%), VRE (2.7%), and CRPA (2.4%). Incidence-density of all and WPAP isolates were 1.91 and 0.77/1000 patients-day, respectively. Carbapenem-resistant <em>Klebsiella pneumoniae</em> (CRKP) was the most common CRE, corresponding to 14.2% of all BSIs. <em>A. baumannii</em> isolates presented the highest proportion of WPAP (87.8%). Mortality rates were higher in patients with BSIs by WPAP than non-WPAP isolates. KPC (64.4%) was the predominant carbapenemase in CRE, followed by NDM (28.4%) and KPC + NDM co-production (7.1%). OXA-23 was the most frequent in CRAB.</div></div><div><h3>Interpretation</h3><div>A high frequency of WPAP bacteria, particularly CRKP and CRAB, were found in healthcare-associated BSIs in Brazil, posing them as a major public health problem in this country.</div></div><div><h3>Funding</h3><div><span>National Council for Scientific and Technological Development</span>, Brazil.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"43 ","pages":"Article 101004"},"PeriodicalIF":7.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143131555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonas Alex Morales Saute , Virginia Picanço-Castro , Ana Carolina de Freitas Lopes , João Batista da Silva Júnior , Johanna Henriques Nehm , Franciele dos Santos Maciel , Ida Vanessa Doederlein Schwartz , Juliana Maria Ferraz Sallum , Margareth Castro Ozelo , Roberto Giugliani , Martin Bonamino , Hilda Petrs-Silva , Guilherme Baldo
{"title":"Clinical trials to gene therapy development and production in Brazil: a review","authors":"Jonas Alex Morales Saute , Virginia Picanço-Castro , Ana Carolina de Freitas Lopes , João Batista da Silva Júnior , Johanna Henriques Nehm , Franciele dos Santos Maciel , Ida Vanessa Doederlein Schwartz , Juliana Maria Ferraz Sallum , Margareth Castro Ozelo , Roberto Giugliani , Martin Bonamino , Hilda Petrs-Silva , Guilherme Baldo","doi":"10.1016/j.lana.2025.100995","DOIUrl":"10.1016/j.lana.2025.100995","url":null,"abstract":"<div><div>Challenges related to the implementation of gene therapy products are daunting for low-to middle-income countries, such as Brazil, and include the creation of an appropriate technical, regulatory, and economic environment. In this manuscript, we give an overview of historical aspects, as well as the current state of clinical trials and approved gene therapy products for commercialization in Brazil. Focusing on gene replacement and CAR-T cell therapies, we discuss the main advances, limitations, and difficulties faced by the country in the production, approval, and incorporation of such products into the public health system. Finally, we highlight the potential leading role that low-to middle-income countries can have in this industry, not only by providing their own vector supply but also by addressing important issues related to the sustainability and long-term global affordability of gene therapy products.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"43 ","pages":"Article 100995"},"PeriodicalIF":7.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143131160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}