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Well-balanced plant-based diets can promote health and reduce environmental impact. However, evidence from interventional studies remains limited. This pilot intervention study aimed to provide exploratory insights into potential challenges associated with the EAT-IT dietary pattern, an adaptation of the EAT-Lancet Healthy Reference Diet. Nine subjects (mean age 26 ± 2 years, 5 females) participated in a 6-week randomized controlled cross-over trial. Participants followed two isocaloric interventions: the EAT-IT dietary pattern and a control diet based on the Italian Food-Based Dietary Guidelines. Dietary intake was recorded using 7-day food records. Anthropometric measurements and metabolic parameters were collected according to standardized and validated protocols. Gut microbiota was analyzed through 16 S rRNA gene sequencing and taxonomic profiling. Acceptability was evaluated via a validated questionnaire. Nutritional analysis showed that the EAT-IT pattern significantly increased fiber intake from 11.3 ± 5.2 to 15.1 ± 4.2 g/1000 kcal and ω-6 fatty acid intake from 5.7 ± 2.2 to 6.6 ± 1.9 g/day (p < 0.05 for interaction). Regarding metabolic markers, a significant within-group reduction (p < 0.05) was observed for fasting insulin (8.4 ± 2.2 to 6.5 ± 2.2 µU/mL) and HOMA1-IR (2.0 ± 0.6 to 1.5 ± 0.5). Changes in gut microbiota were also observed, specifically an increase in Bacteroides and a decrease in Coriobacteriaceae. While generally well-accepted, participants reported a higher perceived effort for EAT-IT, particularly regarding legume preparation. Despite the small sample size, this pilot study offers relevant insights into key aspects of sustainable plant-based diets, underscoring the necessity for further investigation.
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Post-Covid syndrome is a debilitating condition which may be caused and/or aggravated by autoantibodies. The current study aimed to determine whether autoantibody depletion by immunoadsorption is effective to reduce the symptom burden of patients with post-Covid syndrome. IAMPOCO was a randomised, patient-blinded, sham-controlled crossover trial of immunoadsorption with tryptophan adsorbers versus sham treatment in patients with post-Covid syndrome at a tertiary academic care centre. The primary outcome was the difference in change in symptom severity before and after the respective therapies. Secondary outcomes included treatment safety, prevalence of autoantibodies against G protein-coupled receptors (adrenergic and muscarinergic receptors), and the influence of treatment on autoantibody levels. 40 patients with post-Covid syndrome and a symptom severity of at least 2 on the Post-Covid-19 Functional Scale were included and randomised to a treatment sequence. There was no difference in change in symptom severity between immunoadsorption and sham; odds ratio in Post-Covid-19 Functional Scale, OR = 1.17 (95% CI, 0.41-3.36; p = 0.771), mean difference in MFI-20 2.4 (95% CI, -3.7-8.5; p = 0.437), in CFS 0.09 (95% CI, -4.5 to 4.7; p = 0.970), in Bell-Scale -2.6 (95% CI, -6.9 to 1.8; p = 0.246), in MoCA score -0.01 (95% CI, -1.2 to 1.1, p = 0.993) and in Handgrip-strength deviation from individual normal value 1.3 (-0.83 to 3.5, p = 0.234). 34 adverse events occurred, 10 during or after sham treatment and 24 during or after immunoadsorption. Autoantibodies against G protein-coupled receptors were depleted by immunoadsorption but not sham treatment. Immunoadsorption was not effective in reducing symptom burden in post-Covid syndrome. Ministry of Health, state of Rhineland-Palatinate; Mainz University Medical Centre; DIAMED Medical Technology. Trial Registration: ClinicalTrials.gov, number NCT05841498.
Long-acting injectable cabotegravir (CAB-LA) offers a promising alternative to daily oral PrEP. However, studies evaluating PrEP choice and mHealth tools designed to support informed PrEP decision-making in real-world public health settings are scarce. We evaluated PrEP choice and the impact of an mHealth tool. ImPrEP CAB Brasil is a prospective, multicenter, quasi-experimental, implementation study conducted in six public health services in Brazil. Eligible participants were PrEP-naïve cisgender men, transgender and non-binary persons who have sex with men, aged 18-30 years, who tested negative for HIV. Participants were offered a person-centered model that provided a choice between same-day delivery of CAB-LA and oral PrEP. To support informed decision-making, participants were allocated (1:1) to standard-of-care counseling (SOC) or mHealth tool + SOC (first half enrolled in each site received SOC and the remaining received mHealth + SOC). Modified Poisson regression models estimated the effects of exposures of interest, study arm and Decisional Conflict Scale (DCS), on CAB-LA choice. Registered at ClinicalTrials.gov (NCT05515770). From October-2023 to October-2024, 1447 participants were enrolled: 738 (51.0%) to SOC arm and 709 (49.0%) to mHealth + SOC arm. Overall, 1201 (82.9%) participants chose CAB-LA. Participants allocated to mHealth + SOC arm were more likely to choose CAB-LA compared to SOC (PR: 1.15; 95% CI 1.10-1.21). Higher DCS scores were associated with a lower prevalence ratio of choosing CAB-LA (PR: 0.99; 95% CI 0.98-0.99). A total of 678 (95.7%) participants were satisfied with the mHealth tool and 659 (92.9%) found it supported PrEP decision. We found a strong preference for CAB-LA among young sexual and gender diverse populations. The mHealth intervention was highly acceptable and supported informed-decision, indicating its utility as a scalable strategy in real-world settings. These findings are crucial for guiding the equitable scale-up of CAB-LA and advancing HIV prevention in Latin America. Unitaid, WHO, Brazilian Ministry of Health. O cabotegravir injetável de ação prolongada (CAB-LA) oferece uma alternativa promissora à PrEP oral diária. No entanto, são escassos os estudos que avaliam a escolha da PrEP e as ferramentas de saúde móvel (mHealth) destinadas a apoiar a tomada de decisão informada sobre a PrEP em contextos reais de saúde pública. Avaliamos a escolha da PrEP e o impacto de uma ferramenta de saúde móvel. O ImPrEP CAB Brasil é um estudo prospectivo, multicêntrico, quase-experimental de implementação, realizado em seis serviços de saúde pública no Brasil. Os participantes elegíveis eram homens cisgêneros, pessoas transgênero e não binárias que fazem sexo com homens, com idade entre 18 e 30 anos, sem histórico de uso de PrEP e com resultado negativo para HIV. Foi oferecido aos participantes um modelo centrado na pessoa que proporcionava a escolha entre a administração no mesmo dia do CAB-LA e a PrEP oral. Para apoiar a tomada de decisão informada, os participantes foram alocados (1:1) ao aconselhamento padrão de atendimento (SOC) ou à ferramenta mHealth + SOC. Modelos de regressão de Poisson modificados estimaram os efeitos das exposições de interesse, do braço do estudo e da Escala de Conflito Decisório (ECS) sobre a escolha do CAB-LA. Estudo registrado no ClinicalTrials.gov (NCT05515770). De outubro de 2023 a outubro de 2024, foram recrutados 1.447 participantes: 738 (51,0%) no grupo SOC e 709 (49,0%) no grupo mHealth+SOC. No total, 1.201 (82,9%) participantes escolheram CAB-LA. Os participantes alocados ao braço mHealth+SOC foram mais propensos a escolher CAB-LA em comparação com o SOC em um modelo ajustado para características do local, sociodemográficas e comportamentais (RP 1,15; IC 95% 1,10–1,20). A ECS foi associada a uma redução na razão de prevalência da escolha do CAB-LA (RP 0,99; IC 95% 0,98–0,99). Um total de 678 (95,7%) participantes ficou satisfeito com a ferramenta mHealth e 659 (92,9%) consideraram que ela apoiou a decisão sobre a PrEP. Constatamos uma forte preferência pelo CAB-LA entre jovens de minorias sexuais e de gênero. A intervenção de mHealth foi altamente aceitável e apoiou a tomada de decisão informada, indicando sua utilidade como estratégia escalável em contextos do mundo real. Esses achados são cruciais para orientar a ampliação equitativa do CAB-LA e promover a prevenção do HIV na América Latina. Unitaid, OMS, Ministério da Saúde do Brasil, ViiV. Profilaxia pré-exposição ao HIV; cabotegravir; PrEP de ação prolongada; Brasil; minorias sexuais e de gênero; América Latina. El cabotegravir inyectable de acción prolongada (CAB-LA) ofrece una alternativa prometedora a la PrEP oral diaria. Sin embargo, son escasos los estudios que evalúan la elección de la PrEP y las herramientas de salud móvil (mHealth) destinadas a apoyar la toma de decisiones informadas sobre la PrEP en contextos reales de salud pública. Evaluamos la elección de la PrEP y el impacto de una herramienta de salud móvil. ImPrEP CAB Brasil es un estudio prospectivo, multicéntrico, cuasi-experimental de implementación, realizado en seis servicios de salud pública en Brasil. Los participantes elegibles eran hombres cisgénero, personas transgénero y no binarias que tienen relaciones sexuales con hombres, con edades entre los 18 y los 30 años, sin antecedentes de uso de PrEP y con resultado negativo para el VIH. Se ofreció a los participantes un modelo centrado en la persona que permitía elegir entre la administración el mismo día del CAB-LA y la PrEP oral. Para apoyar la toma de decisiones informada, los participantes fueron asignados (1:1) al asesoramiento estándar de atención (SOC) o a la herramienta mHealth + SOC. Se utilizaron modelos de regresión de Poisson modificados para estimar los efectos de las exposiciones de interés, del grupo del estudio y de la Escala de Conflicto Decisorio (ECS) sobre la elección de la CAB-LA. Estudio registrado en ClinicalTrials.gov (NCT05515770). Entre octubre de 2023 y octubre de 2024, se reclutaron 1.447 participantes: 738 (51,0 %) en el grupo SOC y 709 (49,0 %) en el grupo mHealth+SOC. En total, 1.201 (82,9 %) participantes eligieron el CAB-LA. Los participantes asignados al grupo mHealth+SOC fueron más propensos a elegir el CAB-LA en comparación con el SOC en un modelo ajustado por características del centro, sociodemográficas y de comportamiento (RP 1,15; IC del 95 %: 1,10–1,20). El ECS se asoció con una reducción en la razón de prevalencia de la elección de la CAB-LA (RP 0,99; IC del 95 %: 0,98–0,99). Un total de 678 (95,7 %) participantes se mostraron satisfechos con la herramienta mHealth y 659 (92,9 %) consideraron que esta les ayudó a tomar la decisión sobre la PrEP. Observamos una fuerte preferencia por el CAB-LA entre los jóvenes de minorías sexuales y de género. La intervención de mHealth fue muy bien aceptada y apoyó la toma de decisiones informadas, lo que indica su utilidad como estrategia escalable en contextos del mundo real. Estos hallazgos son cruciales para orientar la ampliación equitativa del CAB-LA y promover la prevención del VIH en América Latina. Unitaid, OMS, Ministerio de Salud de Brasil, ViiV. Profilaxis previa a la exposición al VIH; cabotegravir; PrEP de acción prolongada; Brasil; minorías sexuales y de género; América Latina.
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Patients with unresectable hepatocellular carcinoma have a poor prognosis and treatments with long-term benefits are needed. Anti-PD-L1 or anti-PD-1 plus anti-VEGF or anti-CTLA-4 double combinations are validated, first-line, systemic immunotherapies. We report the preplanned phase 2 results of the phase 2-3 PRODIGE 81-FFCD 2101-TRIPLET-HCC trial investigating the survival outcomes and safety profile of a triple combination of atezolizumab, bevacizumab, and ipilimumab in a first-line setting. This randomised, open-label, phase 2-3 trial enrolled patients aged 18 years or older with unresectable hepatocellular carcinoma without previous systemic therapy at 36 hospitals in France. Patients had at least one measurable untreated lesion per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1), Child-Pugh class A disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned (1:1) to receive intravenous treatment every 3 weeks for up to 2 years with atezolizumab 1200 mg plus bevacizumab 15 mg/kg (plus ipilimumab 1 mg/kg for up to four doses), or atezolizumab plus bevacizumab alone. Subsequent follow-up was for a further 2 years. Randomisation was done centrally by the study funder, via an electronic case report form, using the minimisation method, and stratified by centre, ECOG performance status, macrovascular invasion or extrahepatic spread (or both), and baseline α-fetoprotein. We report the non-comparative phase 2 results with a primary endpoint of objective response (complete or partial) within the first 24 weeks of treatment, assessed per investigator by RECIST v1.1, in patients who received at least the first dose of study medication (modified intention-to-treat population); 35 patients in the experimental group needed to have had an objective response at week 24 for the trial to progress to phase 3. Missing data were not replaced. The trial is registered with ClinicalTrials.gov (NCT05665348) and is complete. Between March 9, 2023, and Sept 20, 2024, 229 patients were randomly assigned to treatment and 226 received at least one dose of study medication; 113 patients received atezolizumab plus bevacizumab plus ipilimumab and 113 received atezolizumab plus bevacizumab. 206 (91%) patients were male and 20 (9%) were female. At 24 weeks, 34 (30% [80% CI 24-36]) patients in the atezolizumab plus bevacizumab plus ipilimumab group had an objective response as had 31 (27% [22-34]) patients in the atezolizumab plus bevacizumab group. The trial was therefore stopped and did not progress to phase 3. The most common (>2% of patients) investigator-assessed treatment-related, grade 3-4 adverse events in the atezolizumab plus bevacizumab plus ipilimumab group were colitis (four [4%] patients), confusional syndrome (three [3%]), arterial hypertension (11 [10%]), and asthenia (six [5%]); the most common in the atezolizumab plus bevacizumab group were acute renal failure (three [3%] patients), proteinuria (four [4%]), gastrointestinal bleeding (six [5%]), arterial hypertension (13 [12%]), increased aspartate aminotransferase (three [3%]), increased alanine aminotransferase (three [3%]), and increased lipasaemia (three [3%]). Serious adverse events were reported in 55 (49%) patients in the atezolizumab plus bevacizumab plus ipilimumab group and in 48 (42%) patients in the atezolizumab plus bevacizumab group. Treatment-related adverse events resulting in death occurred in six (5%) patients in the atezolizumab plus bevacizumab plus ipilimumab group and none in the atezolizumab plus bevacizumab group. The addition of ipilimumab to atezolizumab plus bevacizumab did not show any benefit in patients with previously untreated, unresectable hepatocellular carcinoma. These results do not support the addition of low-dose (1 mg/kg) ipilimumab to atezolizumab plus bevacizumab as a first-line treatment in this setting. Fédération Francophone de Cancérologie Digestive.
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