Gestione dell'infezione da HIV: importanza dell'ottimizzazione della terapia [Infettivologia]

La gestione dell’infezione da HIV ha fatto enormi progressi, portando oggi la maggior parte delle persone con HIV in trattamento a raggiungere e mantenere una viremia non rilevabile. Tuttavia, l’efficacia della terapia antiretrovirale (ART) non è più il solo parametro da considerare: l’ottimizzazione della terapia è diventata fondamentale per garantire che il trattamento sia ben tollerato, sostenibile e adattato alle esigenze individuali, migliorando così l’aderenza e la qualità di vita del soggetto, in una prospettiva di successo a lungo termine.

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Carcinoma rinofaringeo: la commissione europea approva tislelizumab in combinazione con chemioterapia come trattamento di prima linea [Ema]

BeOne Medicines Ltd., azienda oncologica a livello globale, ha annunciato oggi che la Commissione Europea ha approvato tislelizumab, in combinazione con gemcitabina e cisplatino, per il trattamento di prima linea dei pazienti adulti con carcinoma rinofaringeo (NPC) recidivante o metastatico, non suscettibile di intervento chirurgico o radioterapico curativo.

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Presentato in Senato il Position Paper sui PDTA per amiloidosi da transtiretina  [Cardio]

Un paziente con amiloidosi cardiaca da transtiretina (ATTR) oggi in Italia può ricevere diagnosi e cure molto diverse a seconda della Regione in cui vive. Eppure, questa malattia rara, spesso sottovalutata e diagnosticata troppo tardi, necessita di un percorso di cura rapido, personalizzato e multidisciplinare.
Per rispondere a questa sfida, Bistoncini Partners ha realizzato, con il contributo non condizionante di Pfizer, il Position Paper: “L’importanza dei PDTA personalizzati per la gestione del paziente con Amiloidosi da Transtiretina”, che viene oggi presentato nel corso di una conferenza stampa promossa dalla Senatrice Elena Murelli

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The Impact of Fontan Circulatory Failure on Heart Transplant Survival: A 20-Center Retrospective Cohort Study

Circulation, Ahead of Print. BACKGROUND:Fontan circulatory failure (FCF) is a chronic state in palliated single ventricle heart disease with high morbidity and mortality rates, including heart failure, multisystem end-organ disease, and need for heart transplant. Specific FCF morbidities have not been rigorously defined, limiting study of how FCF morbidities affect pre–heart transplant and post–heart transplant outcomes. We hypothesized that FCF-related morbidities affect survival from heart transplant waitlisting through 1 year after heart transplant.METHODS:This 20-center, retrospective cohort study collected demographic, medical/surgical history, waitlist, and peri- and post–heart transplant data, and a priori defined FCF-specific morbidities, in Fontan patients who were listed for heart transplant from 2008 through 2022. Univariate 2-group statistics compared surviving individuals with those who died anytime from waitlisting to 1 year after heart transplant, died on the waitlist, or underwent transplant and died within 1 year after transplant. Using covariates from both univariate analyses, multivariable logistic regression determined the primary study outcome of independent FCF risk factors for death between waitlist and 1 year after heart transplant.RESULTS:Of 409 waitlisted patients, 24 (5.9%) died on the waitlist. Of the 341 (83.4%) who underwent transplant, 27 (8.5%) did not survive to 1 year. Univariate risk factors for waitlist death included higher aortopulmonary collateral burden, >1 hospitalization in the previous year, younger age, sleep apnea, higher New York Heart Association class, nonenrollment in school or work, and single-parent home. Risk factors for 1-year post–heart transplant mortality included hypoplastic left heart syndrome diagnosis, patent fenestration, anatomic Fontan obstruction, clinical cyanosis (pulse oximetry 1 hospitalization in the year before waitlisting (adjusted odds ratio, 2.0 [95% CI, 1.0–4.1];P=0.05) and clinical cyanosis (adjusted odds ratio, 5.0 [95% CI, 1.8–13.4];P=0.002).CONCLUSIONS:Patients with Fontan palliation selected for heart transplant have substantial mortality rates from waitlisting through transplant. Among FCF-specific morbidities, cyanosis is associated with worsened survival and necessitates further study. Clinical morbidity of any type requiring repeated hospital admission also should prompt consideration of heart transplant.

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Incidence, progression and predictors of chronic kidney disease among adult HIV/AIDS patients on antiretroviral treatment in comprehensive specialised hospitals in the Amhara Region, Ethiopia, 2022: a multi-centre retrospective follow-up study

Objective
To assess the incidence, progression and predictors of chronic kidney disease among adult patients living with HIV/AIDS who are receiving antiretroviral therapy.

Design
An institution-based, multicentre retrospective follow-up study was conducted among a randomly selected sample of 535 adult patients. Data were entered into Epi Data version 4.6.0 and analysed using STATA version 14.0. A Cox proportional hazards regression model was fitted to identify independent predictors of chronic kidney disease incidence. Variables with p

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Understanding Predictors of Lifelong Initiation and Follow-up Treatment for adolescents and youth living with HIV (UPLIFT): an integrated prospective cohort in Eastern Cape, South Africa

Purpose
Adolescents living with HIV (ALHIV) are a priority population for achieving global HIV prevention and treatment targets but experience poorer outcomes than adults. Long-term follow-up is essential to understand their transition into adulthood. By linking self-reported survey data with routine laboratory records, we established a social science clinical cohort of ALHIV South Africa’s Eastern Cape to explore factors shaping their long-term health and well-being.

Participants
Eligible participants were adolescents who were part of a three-wave quantitative cohort of ALHIV and not living with HIV (2014–2018) and had consented (adolescent and caregiver) to having their self-reported interviews linked with routine health records (n=1563). Adolescents were recruited into the existing three-wave cohort through clinic and community-based methods (97% enrolment, >90% retention over three waves). Between 2019 and 2022, we abstracted laboratory test records from the National Health Laboratory Services database for all eligible participants, with matching based on demographic variables. Individuals with at least one HIV-related record form our ‘lifelong social science cohort’, a total of 956 ALHIV (852 of 1107 ALHIV and 104 of 456 HIV-uninfected).

Findings to date
A total of 32 886 laboratory test records from 2004 to 2023 were matched through three rounds of data extraction, using iteratively refined record-linking searches. Most records were viral load (8864) and CD4 count (6801) results, with a median of 10 (IQR: 7–14) and 8 (IQR: 5–11) tests per matched adolescent, respectively. Overall, 956 of 1563 adolescents (61%) were successfully linked to laboratory data, including 852 of 1107 (77%) ALHIV. Analysis of the matched cohort survey-laboratory data provided several insights. Self-reported antiretroviral therapy adherence was strongly associated with viral suppression, even after adjusting for covariates. The strongest predictors of suppression were not reporting missed doses in the past 3 days, past week and not missing clinic appointments in the past year. Among adolescent girls and young women living with HIV, access to safe and affordable facilities, and kind and respectful staff were associated with a higher likelihood of multiple improved HIV-related outcomes, including viral suppression. Exposure to sexual and intimate partner violence predicted worse viral load outcomes among adolescents.

Future plans
This integrated prospective cohort provides an opportunity to characterise long-term HIV treatment outcomes among ALHIV in Africa. We will investigate how individual, familial, community and healthcare experiences in childhood, and adolescence shape these outcomes. Since the COVID-19 pandemic happened during the period of matched data, we will also investigate the potential effect of the COVID-19 pandemic on adolescent HIV treatment outcomes, with potential subgroup analyses for individuals with available COVID-19-related results.

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Association between loneliness and depression, anxiety and anger during the COVID-19 pandemic: a nationwide population-based survey

Objectives
This study aims to determine the association between loneliness and depression, anxiety and anger with a representative sample of the general population in Korea, which are the most prevalent mental health problems during the pandemic.

Design
Cross-sectional study.

Setting
National survey across all 17 provinces in South Korea between December 2021 and January 2022.

Participants
We conducted a national survey on 2699 participants aged 19–84 years using proportional stratified sampling. Using the UCLA Loneliness Scale and standardised questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7) and anger (Patient-Reported Outcomes Measurement Information System-Anger), we explored the prevalence and association of loneliness with these mental health outcomes.

Primary and secondary outcome measures
Primary outcomes included the prevalence and co-occurrence of depression, anxiety and anger across different levels of loneliness.

Results
Of total, 20.7% and 2.1% experienced moderately high and high levels of loneliness, respectively. Among participants with high levels of loneliness, 11.8%, 5.9% and 11.8% had depression, anxiety and anger, respectively, and 28.7% of them had depression, anxiety and anger together. The adjusted prevalence of depression was 0.2 (95% CI 0.0 to 0.5), 8.2 (95% CI 6.7 to 9.7), 31.3 (95% CI 27.4 to 35.3) and 63.5 (95% CI 50.1 to 76.8) for low, moderate, moderately high and high levels of loneliness, respectively. Similarly, increased adjusted prevalence of anxiety and anger was observed ㅈwith higher levels of loneliness.

Conclusions
Lonely people have a higher risk of depression, anxiety and anger. Identifying individuals who may be vulnerable to loneliness is important for early intervention.

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Tumore del seno metastatico: Aifa approva elacestrant, dimezza il rischio di progressione [Oncologia-Ematologia]

Nelle pazienti con carcinoma mammario metastatico, una nuova terapia ormonale mirata, elacestrant, ha ridotto il rischio di progressione o morte del 45%. L’Agenzia Italiana del Farmaco (AIFA) ha approvato la rimborsabilità di elacestrant per il trattamento di donne in postmenopausa, e di uomini, con carcinoma mammario localmente avanzato o metastatico positivo per i recettori degli estrogeni (ER+) e negativo per la proteina HER2 (HER2-), con una mutazione attivante del gene ESR1, che mostrano progressione della malattia in seguito ad almeno una linea di terapia endocrina comprendente un inibitore delle cicline CDK 4/6.

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Fattori di rischio per diabete nei pazienti con epatite C: il ruolo chiave del genotipo 3a e della cirrosi [Gastroenterologia ed epatologia]

Uno studio pubblicato su BMC Gastroenterology ha evidenziato che nei pazienti con epatite C cronica (CHC), genotipo 3a, età, cirrosi, ipertensione e insulino-resistenza e altri fattori indipendenti sono associati allo sviluppo di diabete di tipo 2 (T2DM). Interventi precoci nei pazienti a rischio possono migliorare la prognosi e ridurre le complicanze gravi.

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MSD si rafforza nelle patologie respiratorie e con $10 mld fa sua Verona Pharma [Business]

MSD ha annunciato l’acquisto di Verona Pharma per 10 miliardi di dollari. L’azienda ottiene così il controllo di Ohtuvayre (ensifentrina), un farmaco per il trattamento di mantenimento della broncopneumopatia cronica ostruttiva (BPCO). Il prezzo pattuito, 107 dollari per azione (american depositary shares), rappresenta un premio del 23% rispetto al prezzo di chiusura di martedì (86,86 dollari).

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Interventions that use highly visual social media platforms to tackle unhealthy body image in adolescents and young adults: a systematic review protocol

Introduction
Social media sites are increasingly used to assess and treat different mental health problems in adolescents and young adults. However, it is still unclear which social network sites are the most used for this purpose and what interventions for tackling unhealthy body image have been validated. This systematic review will assess evidence on the effectiveness of social media interventions in improving unhealthy body image among adolescents and young adults.

Methods and analysis
Five databases, including Embase, Scopus, MEDLINE, Web of Science (Core Collection) and PsycINFO, will be consulted, with a publication window starting in 2011 and ending on 31 October 2024. Rayyan software will detect and eliminate duplicates. We will include only studies based on social media-based interventions for adolescents and young adults with body image problems. Two independent reviewers will screen titles, abstracts and full-text articles, resolving conflicts through discussion with a third reviewer as needed. The two reviewers will complete the risk of bias assessments for each included study, using the Joanna Briggs Institute critical appraisal checklists for randomised controlled trials and quasi-experimental studies. We will report on the characteristics of studies, participants and interventions in descriptive narrative form, along with the results from the assessment of social media interventions.

Ethics and dissemination
Universidad Cesar Vallejo’s ethics committee approved this systematic review protocol as part of a wider project (code 100-CEI-EPM-UCV-2022). Results will be shared via social media to engage stakeholders and promote awareness of body image issues.

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Association of triglyceride-glucose index with in-hospital outcomes in patients with acute myocardial infarction: a retrospective, single-centre, cohort study in China

Objectives
To investigate the association between triglyceride-glucose (TyG) index levels at hospital admission and the risk of in-hospital adverse events, including all-cause mortality, in patients with acute myocardial infarction (AMI). The primary hypothesis was that higher TyG index levels are associated with greater risk of adverse in-hospital outcomes.

Design
Retrospective cohort study.

Setting
Tertiary hospital inpatient care in China. The study included consecutively hospitalised patients with AMI between 1 August 2011 and 10 January 2022.

Participants
A total of 3458 patients with AMI were included. The mean age was 60.8 years, and 78.4% were men. Patients were excluded if they had incomplete data for TyG index calculation or outcome ascertainment.

Interventions
No therapeutic intervention was assigned; the study was observational. TyG index was calculated using fasting triglycerides and fasting plasma glucose levels at admission.

Primary and secondary outcome measures
The primary outcome was all-cause in-hospital mortality. Secondary outcomes included cardiogenic shock and fatal rapid arrhythmia. Outcomes were identified through standardised clinical records.

Results
Among 3458 patients, 375 (10.84%) died during hospitalisation, 236 (6.84%) developed cardiogenic shock and 147 (4.25%) experienced fatal rapid arrhythmia. After multivariable adjustment, higher TyG index levels were significantly associated with increased odds of all-cause mortality (OR, 1.27; 95% CI, 1.02 to 1.57; p

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Implementation of an intervention to scale up coverage of pneumonia management in children younger than 5 years in a north Indian district: protocol for a quasi-experimental, mixed-methods, pre-post implementation study

Introduction
The National Family Health Survey-5 has reported an under-five mortality rate of 41.9 per 1000 live births in India. Pneumonia, one of the leading causes of under-five mortality, contributes substantially to this figure. The Indian government has made efforts through multiple national programmes, but pneumonia-specific mortality remains high. The Government of India revised their Childhood Pneumonia Management Guidelines in 2019 to improve under-five pneumonia prevention and management. This implementation study aims to achieve a high population-based coverage of pneumonia treatment for under 5 yearold children in the Palwal district of India.

Method and analysis
This implementation study uses a quasi-experimental pre-post design and a mixed-methods approach, conducted in three phases: (i) formative research, (ii) model optimisation through iterative testing in a learning block and (iii) scale-up and concurrent evaluation. The study is set in Palwal district, Haryana, and the primary catchment/study area will be the Health and Wellness Centres, the most accessible public health facilities for the community. Approximately 4167 households will be surveyed to capture ~2400 under-five children, among whom about 120 pneumonia cases (based on an estimated 5% prevalence) will be included in the analysis of treatment coverage and outcomes. Quantitative data will be analysed using descriptive statistics and generalised linear models, while qualitative data from focus group discussions and in-depth interviews will be thematically analysed using NVivo software.

Ethics and dissemination
Ethical approval was granted by the ethical committees of the Society for Applied Studies (ERC/IR Pneumonia/2021), the Regional Ethics Committee of Western Norway (2022/531608) and the WHO(ERC.0003652). Additionally, this study has obtained the Government of Haryana state (Memo no. HSHRC/2022/505) and Health Ministry steering committee (approval date: 19 Dec 2022, proposal id 2022–17596) approvals. Informed consent will be obtained from all participants, including caregivers and healthcare workers, prior to data collection. Dissemination meetings in the study country will share results with stakeholders, including Ministry of Health officials, health managers, families of under-five children, community leaders and academia, to discuss national health programme implications. Results will also be shared regionally and globally, with publications and presentations encouraged in national and international forums.

Study registration
Clinical Trials Registry – India, CTRI/2021/03/031622.

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Systematic mapping review of statistical methods applied to the relationships between cancer diagnosis and geographical level factors in UK

Objectives
We examined studies that analysed the spatial association of cancers with demographic, environmental, behavioural and/or socioeconomic factors and the statistical methods applied.

Design
Systematic mapping review.

Data sources
Web of Science (SSCI) (search on 28 July 2022), MEDLINE, SocINDEX and CINAHL (search on 4 August 2022), additional searches included grey literature.

Eligibility criteria for selecting studies
(1) Focused on the constituent countries of the UK (England, Wales, Scotland and Northern Ireland) and its major regions (eg, the North West); (2) compared cancer(s) outcomes with demographic, environmental, behavioural and socioeconomic characteristics by applying methods to identify their spatial association; (3) reported cancer prevalence, incidence rates, relative risk or ORs for a risk factor or to an average level of cancer.

Data extraction and synthesis
A standardised data extraction form was developed and for all studies, core data were extracted including bibliographic information, study design, geographical factors analysed, data aggregation level, methods applied and main findings. We described and synthesised the characteristics of the studies using summary tables, charts and graphs.

Results
52 studies were included covering a variety of objectives and geographical scales. These studies considered different types of cancer, with the most common cancer types analysed being blood and lymphoid cell cancers. The most common methods used to assess the association between cancers and geographical level factors were regression analyses, with the majority being Poisson regression, then logistic and linear regression. Studies were usually conducted at ward and local authority level, or by exact point location when distances from putative risk sources were considered. The results were usually presented in plots or as tables, instead of maps.

Conclusion
Our results highlight the lack of consideration of spatially explicit models in the analysed studies, with the risk of having failed the assumption of independence in the data.

PROSPERO registration number
CRD42022349165.

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Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial

Introduction
Depression is characterised by disruptions in brain circuitry, and interventions like intermittent theta burst stimulation (iTBS) offer the potential for normalising these circuits and improving clinical symptoms. However, personalised treatment targets for depression remain underexplored. This trial aims to evaluate the clinical efficacy of iTBS as an additional treatment to a stable antidepressant regimen in patients with treatment-resistant depression (TRD) by modulating brain circuits identified through personalized brain functional sectors compared with sham treatment. This work is a part of the China Study to Predict Optimised Treatment bioMarkers of Individualised Neuromodulation in Depression project.

Methods and analysis
This is a multi-centre, double-blind, sham-controlled randomised trial, with a 2:1 allocation ratio to 21 days of active or sham iTBS. A total of 360 eligible participants, diagnosed with current treatment-resistant unipolar major depressive disorder, who have been on a stable antidepressant regimen for at least 4 weeks and are experiencing moderate-to-severe depressive episodes, will be recruited from seven clinical centres in China. The primary outcome is the change in the Montgomery–Asberg Depression Rating Scale immediately following 21-day treatment. Secondary outcomes include response rate and remission rate, change in the Hamilton Rating Scale for Depression, efficacy sustainability and recurrence within 6 months post-treatment. Additionally, safety, blinding, dropout and potential moderators of response will be examined.

Ethics and dissemination
The study has been approved by each centre’s ethics committee, with the first ethical approval granted by the Ethics Committee of Beijing Anding Hospital on 30 December 2022 (approval 2022206FS-2). Written informed consent will be obtained from all participants prior to enrolment. The study results will be published in relevant peer-reviewed journals.

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