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Letter: “Tenofovir Alafenamide—The ‘Star of Potential’ for Long-Term Chronic Hepatitis B Treatment. A Deep-Dive Analysis of Phase 3 Clinical Trials.” Authors' Reply 信:“替诺福韦阿拉芬胺——长期慢性乙型肝炎治疗的“潜力之星”。《三期临床试验的深度分析》作者的回答。
IF 6.7 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-09-02 DOI: 10.1111/apt.70358
Maria Buti, the study team
{"title":"Letter: “Tenofovir Alafenamide—The ‘Star of Potential’ for Long-Term Chronic Hepatitis B Treatment. A Deep-Dive Analysis of Phase 3 Clinical Trials.” Authors' Reply","authors":"Maria Buti, the study team","doi":"10.1111/apt.70358","DOIUrl":"10.1111/apt.70358","url":null,"abstract":"<p>We thank Drs. Dai and Zhu for their comments on our manuscript, ‘Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomized phase 3 trials’, and for highlighting the long-term benefits of tenofovir alafenamide (TAF) in chronic hepatitis B (CHB) management [<span>1</span>].</p><p>We agree that assessing fibrosis regression, cirrhosis reversal, and hepatocellular carcinoma (HCC) incidence is critical to understanding the full impact of long-term antiviral therapy [<span>2</span>]. While serial liver biopsies were not performed, we employed validated non-invasive markers such as FibroTest, endorsed by international guidelines [<span>3</span>]. Indeed, guidelines have shifted away from recommending invasive percutaneous biopsies. At baseline, approximately 10% of patients had compensated cirrhosis; those with decompensated disease were excluded. By Year 8, cirrhosis prevalence substantially declined across all treatment groups [<span>4</span>]. Most patients with cirrhosis at baseline shifted to lower fibrosis categories, and no patients with compensated cirrhosis experienced hepatic decompensation. The overall 8-year HCC incidence was low (1.8%), notably below predictions from established HCC risk scores [<span>5</span>]. HCC was a predefined adverse event of interest with patients screened per local standard of care. Importantly, prospective surveillance with hepatic ultrasonography was introduced at Week 96 and conducted biannually thereafter. In a recent 5-year analysis of these trials, TAF and tenofovir disoproxil fumarate (TDF) were associated with significantly lower HCC incidence than predicted for untreated patients, with a 68% and 44% reduction in the TAF and TDF-TAF groups, respectively [<span>6</span>]. An extended 8-year analysis is underway. Collectively, these findings underscore the long-term capacity of TAF to alter the natural history of HBV, supporting its role as a preferred therapeutic option for patients with CHB.</p><p>We also agree that broader inclusion of patients with co-infections, advanced liver disease, and diverse racial and ethnic backgrounds would enhance the generalisability of TAF's safety and efficacy profiles across broader patient populations [<span>2</span>]. The two phase 3 trials for TAF enrolled a global population, while subsequent studies have examined TAF in diverse populations such as in patients with renal/hepatic impairment and HIV/HBV coinfection [<span>7, 8</span>]. Future real-world studies should aim to capture underrepresented groups to inform clinical practice across diverse settings. Despite bearing a high burden of HBV, patients from Sub-Saharan Africa remain underrepresented in clinical trials [<span>9</span>]. Greater inclusion of these and other underserved groups is essential to ensure CHB treatment strategies are globally relevant and equitable.</p><p>Although economic factors were beyond our manuscript'","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"62 7","pages":"762-763"},"PeriodicalIF":6.7,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.70358","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144937059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Letter: Tenofovir Alafenamide—The “Star of Potential” for Long-Term Chronic Hepatitis B Treatment. A Deep-Dive Analysis of Phase 3 Clinical Trials 信:替诺福韦阿拉芬胺-长期慢性乙型肝炎治疗的“潜力之星”。3期临床试验的深度分析
IF 6.7 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-09-02 DOI: 10.1111/apt.70343
YaoYao Dai, JunFeng Zhu
{"title":"Letter: Tenofovir Alafenamide—The “Star of Potential” for Long-Term Chronic Hepatitis B Treatment. A Deep-Dive Analysis of Phase 3 Clinical Trials","authors":"YaoYao Dai, JunFeng Zhu","doi":"10.1111/apt.70343","DOIUrl":"10.1111/apt.70343","url":null,"abstract":"<p>I read with great interest the article titled “Eight - Year Efficacy and Safety of Tenofovir Alafenamide for Chronic Hepatitis B Virus Infection: Final Results of Two Randomized Phase 3 Clinical Trials [<span>1</span>].” This study provides valuable insights into the long—term management of chronic hepatitis B (CHB) using tenofovir alafenamide (TAF), which is a significant advancement in the field of hepatology.</p><p>The findings of this study are indeed remarkable. The sustained virological suppression rate over 8 years highlights the potent antiviral efficacy of TAF. Given the chronic nature of hepatitis B infection, long-term viral control is crucial for preventing disease progression to cirrhosis and hepatocellular carcinoma. Although the overall rate of hepatitis B surface antigen (HBsAg) loss is relatively low, it is still noteworthy. HBsAg loss is considered a functional cure for CHB, and any increase in this outcome represents an important step forward in managing this challenging disease.</p><p>Moreover, the safety profile of TAF is commendable. Compared with tenofovir disoproxil fumarate (TDF), TAF has a lower incidence of renal and bone adverse events, which is a major advantage. These side effects have long been a concern in long-term nucleos (t) ide analog therapy, and the improved safety of TAF offers a more favourable risk–benefit ratio for patients who require lifelong treatment. This is especially true for elderly patients or those with comorbidities that may exacerbate renal or bone issues.</p><p>However, I would like to raise some points that merit further discussion. First, although the study demonstrates impressive long-term outcomes, the long-term impact on liver histology and clinical endpoints (such as cirrhosis reversal or hepatocellular carcinoma incidence) would provide a more comprehensive understanding of the benefits of TAF. Longitudinal liver biopsies or non-invasive liver fibrosis markers could offer valuable reference for histological changes associated with long-term TAF treatment [<span>2</span>].</p><p>Second, the study population is relatively homogeneous in terms of baseline characteristics. Future research should strive to include more diverse cohorts, including patients with different racial backgrounds, stages of liver disease, and co-infections. This will help to better understand the efficacy and safety of TAF in real-world settings and its applicability in different patient subgroups [<span>3</span>].</p><p>Lastly, especially in resource–limited settings, the cost–effectiveness of TAF deserves further investigation. Although its superior safety profile may make it valuable for certain populations, the economic burden of long–term treatment needs to be considered. Cost–effectiveness analyses compared with other available treatment options can guide clinical decision–making and health policy [<span>4</span>].</p><p>In summary, the eight-year results of the Phase 3 clinical trials of TAF for CHB are ve","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"62 7","pages":"760-761"},"PeriodicalIF":6.7,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.70343","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144928600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Editorial: A Step Back to Leap Forward—Strategic Nucleos(t)ide Analogue Discontinuation Towards HBV Functional Cure 社论:向飞跃迈出的一步——停止核苷类似物治疗HBV功能性治愈
IF 7.6 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-09-02 DOI: 10.1111/apt.70352
Xuwen Xu, Aili Lu, Shaohang Cai
{"title":"Editorial: A Step Back to Leap Forward—Strategic Nucleos(t)ide Analogue Discontinuation Towards HBV Functional Cure","authors":"Xuwen Xu, Aili Lu, Shaohang Cai","doi":"10.1111/apt.70352","DOIUrl":"https://doi.org/10.1111/apt.70352","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"4 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144928255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Letter: The Complexity of Deciphering Complex Mechanisms That Underpin Changing Trends in Complex Disease 解读复杂疾病变化趋势背后的复杂机制的复杂性
IF 7.6 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-09-01 DOI: 10.1111/apt.70359
Sasza Koczanowski, Jonathan P. Segal
{"title":"Letter: The Complexity of Deciphering Complex Mechanisms That Underpin Changing Trends in Complex Disease","authors":"Sasza Koczanowski, Jonathan P. Segal","doi":"10.1111/apt.70359","DOIUrl":"https://doi.org/10.1111/apt.70359","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"41 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144924066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Burden of Invasive Fungal Diseases in Patients With Alcohol-Related Hepatitis and Organ Failure. 酒精相关性肝炎和器官衰竭患者侵袭性真菌疾病的负担
IF 6.7 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-09-01 DOI: 10.1111/apt.70328
Charlotte Mouliade, Lucia Parlati, Stylianos Tzedakis, Mathis Collier, Samir Bouam, Philippe Sogni, Fanny Lanternier, Alexandre Alanio, Vincent Mallet
{"title":"Burden of Invasive Fungal Diseases in Patients With Alcohol-Related Hepatitis and Organ Failure.","authors":"Charlotte Mouliade, Lucia Parlati, Stylianos Tzedakis, Mathis Collier, Samir Bouam, Philippe Sogni, Fanny Lanternier, Alexandre Alanio, Vincent Mallet","doi":"10.1111/apt.70328","DOIUrl":"https://doi.org/10.1111/apt.70328","url":null,"abstract":"<p><strong>Background: </strong>The burden of invasive fungal diseases (IFDs) in patients with complicated alcoholic hepatitis (CAH)-defined by ≥ 2 hepatic (ascites, jaundice, liver failure, encephalopathy) or extrahepatic (coagulopathy, shock, kidney or respiratory failure) dysfunctions within 30 days-remains poorly characterised.</p><p><strong>Aims: </strong>To assess the burden of IFDs in CAH and compare it with bacterial pneumonia (BP).</p><p><strong>Methods: </strong>We conducted a retrospective nationwide cohort study of adult CAH patients in France (2012-2021). The primary exposure were IFDs. The primary outcome was 3-month mortality or liver transplantation. Associations were assessed with adjusted odds ratios (aORs) in complete-case and propensity score-matched cohorts. A 6-week landmark analysis and time-dependent Cox models were used to evaluate time-varying effects.</p><p><strong>Results: </strong>Among 11,434 CAH patients (median age 55 years; 72% male), 2.2% and 15% developed IFDs and BP, respectively. Three-month survival was 17.5% (95% CI: 13.0-23.0) in IFDs, 46.8% (44.3-49.3) in BP and 60.0% (59.4-61.4) in those without either (p < 0.001). IFDs occurred in 44.3% of patients with BP, and BP increased IFD risk (aOR 2.93, 95% CI: 2.23-3.84). In matched analyses, IFDs were associated with a fourfold increase in mortality (aOR 4.58, 95% CI: 3.02-7.20), while BP showed a lower association (aOR 1.23, 95% CI: 1.06-1.43). IFDs were strong time-dependent predictors of death.</p><p><strong>Conclusions: </strong>IFDs affected 1 in 50 CAH patients and carried a disproportionate mortality risk, compared with BP. These findings support the implementation of targeted screening and early antifungal strategies in CAH management, as for BP.</p>","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":" ","pages":""},"PeriodicalIF":6.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144937068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Meta-Analysis: Comparison of Living Versus Deceased Liver Transplantation for Primary Sclerosing Cholangitis 荟萃分析:活体肝移植与已故肝移植治疗原发性硬化性胆管炎的比较
IF 6.7 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-09-01 DOI: 10.1111/apt.70357
Ana Beatriz Afonso, Carolina Morais da Silva, Paulo Nogueira, Mariana Verdelho Machado
{"title":"Meta-Analysis: Comparison of Living Versus Deceased Liver Transplantation for Primary Sclerosing Cholangitis","authors":"Ana Beatriz Afonso,&nbsp;Carolina Morais da Silva,&nbsp;Paulo Nogueira,&nbsp;Mariana Verdelho Machado","doi":"10.1111/apt.70357","DOIUrl":"10.1111/apt.70357","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aims</h3>\u0000 \u0000 <p>Primary sclerosing cholangitis (PSC) is a rare disease that paradoxically accounts for 5%–15% of liver transplants (LT). The paucity of liver donors is boosting living donor LT (LDLT). We reviewed the literature regarding outcomes of LT in PSC, comparing LDLT with deceased donor LT (DDLT).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A systematic review with meta-analysis was performed through a search on: PubMed, Web-of-Science, Scopus and Cochrane Central, from inception to December 2024. In total, 22 studies were included, enrolling 22,024 patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Compared with LDLT, DDLT was associated with lower 1- (93.80% [95% CI 93.29–94.31] vs. 95.78% [95% CI 94.68–96.88]), 3- (88.81% [95% CI 88.14–89.48] vs. 93.23% [95% CI 91.85–94.61]) and 5-year survival (85.18% [95% CI 84.43–85.92] vs. 91.54% [95% CI 91.01–93.07]), although it had no impact on graft survival. DDLT was associated with a higher risk of post-LT sepsis (OR 3.68 [95% CI 1.02–13.26]), acute rejection (OR 1.75 [95% CI 1.12–2.73]) and PSC recurrence (OR 1.63 [95% CI 1.10–2.42]), but a lower risk of biliary complications (OR 0.29 [95% CI 0.11–0.78]). DDLT recipients were older (MD 4.26 years [95% CI 2.42–6.10]), with higher metabolic dysfunction, more advanced liver disease (higher MELD: MD 6.63 [95% CI 5.56–7.70]), but lower chances of having inflammatory bowel disease (OR 0.66 [95% CI 0.50–0.87]) or cholangiocarcinoma (OR 0.70 [95% CI 0.53–0.92]). DDLT donors were older (MD 2.46 years [95% CI 0.76–4.15]) and cold ischemia time was longer (MD 5.63 h [95% CI 3.18–8.08]).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>In PSC, LDLT seems to be associated with higher post-LT survival, compared with DDLT. This could be explained by earlier referral to LT with lower liver disease burden and better performance status; better graft quality; and shorter cold ischaemia time. PSC patients requiring LT should be encouraged to consider LDLT.</p>\u0000 </section>\u0000 </div>","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"62 8","pages":"768-787"},"PeriodicalIF":6.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144928300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical Features of Portal Hypertension and Their Prognostic Implications in Patients With Autoimmune Hepatitis 自身免疫性肝炎患者门静脉高压的临床特征及其预后意义
IF 7.6 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-08-28 DOI: 10.1111/apt.70349
Lukas Burghart, Sonja Treiber, David Bauer, Emina Halilbasic, Benedikt S. Hofer, Mattias Mandorfer, Michael Gschwantler, Caroline Schwarz, Michael Trauner, Thomas Reiberger, Albert F. Stättermayer
{"title":"Clinical Features of Portal Hypertension and Their Prognostic Implications in Patients With Autoimmune Hepatitis","authors":"Lukas Burghart, Sonja Treiber, David Bauer, Emina Halilbasic, Benedikt S. Hofer, Mattias Mandorfer, Michael Gschwantler, Caroline Schwarz, Michael Trauner, Thomas Reiberger, Albert F. Stättermayer","doi":"10.1111/apt.70349","DOIUrl":"https://doi.org/10.1111/apt.70349","url":null,"abstract":"Background and AimsAutoimmune hepatitis (AIH) may progress to advanced chronic liver disease (ACLD) with clinically significant portal hypertension (CSPH). In this study, we evaluated the prevalence of different clinical CSPH features and their prognostic impact regarding decompensation, liver transplantation (LTX) and death in patients with AIH.MethodPatients with confirmed AIH diagnosis (sIAIHG‐Score ≥ 6) managed at the Vienna General Hospital between 2005 and 2023 were retrospectively analysed.ResultsAmong 271 included patients (76.4% female) with AIH, <jats:italic>n</jats:italic> = 60 (22.1%) presented clinical features of CSPH at diagnosis. During a median follow‐up of 7.2 (IQR 2.9–12.7) years, the proportion with CSPH features increased to <jats:italic>n</jats:italic> = 104 (38.4%). In a multivariable cox regression analysis, both compensated (aHR: 5.77, 95% CI: [1.47–22.71], <jats:italic>p</jats:italic> = 0.012) and decompensated features of CSPH (aHR: 15.73, 95% CI: [4.17–59.33], <jats:italic>p</jats:italic> &lt; 0.0001) were associated with an increased risk of LTX/death, whereas complete biochemical response and higher albumin levels were identified as protective factors. The BAVENO‐VII criteria for ruling‐out CSPH (liver stiffness &lt; 15 kPa and platelet count ≥ 150 G/L) identified AIH patients with a negligible 10Y cumulative incidence of hepatic decompensation (0.8%) and a favourable 10Y transplant‐free survival (97.8%). Overall, <jats:italic>n</jats:italic> = 16 (5.9%) patients died, with <jats:italic>n</jats:italic> = 10 deaths caused by CSPH‐related complications.ConclusionIn patients with AIH, clinical features of CSPH reflect the risk of future hepatic decompensation and mortality. Hence, regular screening for CSPH in AIH patients seems warranted to ensure timely initiation of adequate CSPH‐directed treatment.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"7 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144915749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. 炎症性肠病妊娠管理全球共识声明
IF 6.7 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-08-28 DOI: 10.1111/apt.70290
Uma Mahadevan, Cynthia H Seow, Edward L Barnes, María Chaparro, Emma Flanagan, Sonia Friedman, Mette Julsgaard, Sunanda Kane, Siew Ng, Joana Torres, Gillian Watermeyer, Jesus Yamamoto-Furusho, Christopher Robinson, Susan Fisher, Phil Anderson, Richard Gearry, Dana Duricova, Marla Dubinsky, Millie Long
{"title":"Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease.","authors":"Uma Mahadevan, Cynthia H Seow, Edward L Barnes, María Chaparro, Emma Flanagan, Sonia Friedman, Mette Julsgaard, Sunanda Kane, Siew Ng, Joana Torres, Gillian Watermeyer, Jesus Yamamoto-Furusho, Christopher Robinson, Susan Fisher, Phil Anderson, Richard Gearry, Dana Duricova, Marla Dubinsky, Millie Long","doi":"10.1111/apt.70290","DOIUrl":"https://doi.org/10.1111/apt.70290","url":null,"abstract":"<p><strong>Background & aims: </strong>Pregnancy can be a complex and risk filled event for women with inflammatory bowel disease (IBD). High-quality studies in this population are lacking, with limited data on medications approved to treat IBD during pregnancy. For patients, limited knowledge surrounding pregnancy impacts pregnancy rates, medication adherence, and outcomes. Limited provider knowledge leads to highly varied practices in care affected by local dogma, available resources, individual interpretation of the literature, and fear of harming the fetus. The variations in guidelines by different societies and countries reflect this and lead to confusion for physicians and patients alike. The Global Consensus Consortium is a group of 39 IBD and content experts and 7 patient advocates from 6 continents who convened to review and assess current data and come to an agreement on best practices based on these data.</p><p><strong>Methods: </strong>The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) process was used when sufficient published data were available and the RAND process in those instances where expert opinion was needed to guide consistent practice. Recommendations were informed by the guiding principle that maternal health best supports infant health.</p><p><strong>Results: </strong>The topics were divided into ten categories with 34 GRADE recommendations and 35 consensus statements.</p><p><strong>Conclusions: </strong>Overall, the goal of the group was to provide data-driven and practical guidance to improve the care of women with IBD around the globe based on the best available research.</p>","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":" ","pages":""},"PeriodicalIF":6.7,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144936990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hepatitis B Immunoglobulins Withdrawal in Hepatitis B Virus Mono-Infected Liver Transplant Recipients: An Italian Multicentre Prospective Study. 单一乙肝病毒感染肝移植受者的乙肝免疫球蛋白戒断:一项意大利多中心前瞻性研究
IF 6.7 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-08-27 DOI: 10.1111/apt.70348
Raffaella Viganò, Alessandro Loglio, Clara Dibenedetto, Paola Carrai, Silvia Martini, Ilaria Lenci, Bianca Magro, Sara Conti, Paolo Angelo Cortesi, Chiara Mazzarelli, Chiara Becchetti, Giovanni Perricone, Monica Cucco, Marco Carbone, Donatella Cocchis, Elisa Farina, Luisa Pasulo, Mauro Viganò, Michele Sagasta, Elisabetta Degasperi, Davide Ghinolfi, Pietro Lampertico, Stefano Fagiuoli, Luca Saverio Belli
{"title":"Hepatitis B Immunoglobulins Withdrawal in Hepatitis B Virus Mono-Infected Liver Transplant Recipients: An Italian Multicentre Prospective Study.","authors":"Raffaella Viganò, Alessandro Loglio, Clara Dibenedetto, Paola Carrai, Silvia Martini, Ilaria Lenci, Bianca Magro, Sara Conti, Paolo Angelo Cortesi, Chiara Mazzarelli, Chiara Becchetti, Giovanni Perricone, Monica Cucco, Marco Carbone, Donatella Cocchis, Elisa Farina, Luisa Pasulo, Mauro Viganò, Michele Sagasta, Elisabetta Degasperi, Davide Ghinolfi, Pietro Lampertico, Stefano Fagiuoli, Luca Saverio Belli","doi":"10.1111/apt.70348","DOIUrl":"https://doi.org/10.1111/apt.70348","url":null,"abstract":"<p><strong>Background & aims: </strong>Despite recommendations from scientific societies that hepatitis B immunoglobulin (HBIG) can be safely discontinued, centres across Europe continue to use the combination nucleoside analogues (NAs) plus HBIG for long-term prophylaxis against hepatitis B virus (HBV) recurrence after liver transplant (LT). The aim of this study was to evaluate the safety of HBIG withdrawal in a cohort of LT recipients on long-term HBIG+NAs.</p><p><strong>Methods: </strong>All patients under third-generation NAs + HBIG and who adhered to the INSIGHT-B protocol were followed up after HBIG withdrawal, in a multicentre, prospective, Italian cohort study, to evaluate the risk of HBV reactivation. The probability of HBsAg reappearance after HBIG withdrawal, stratified by presence of HCC at LT, was estimated through Kaplan-Meier curves and Log-rank tests.</p><p><strong>Results: </strong>Between February 2021 and January 2024, 222 liver transplant (LT) recipients withdrew HBIG 11.6 (IQR 6.7-17.0) years after LT and were followed up for a median time of 24 months. After HBIG withdrawal, Hepatitis B surface antigen (HBsAg) reappearance was observed in 12 patients (5.4%) with a cumulative 1-, 2- and 3-year recurrence rate of 4.08%, 5.36% and 6.89% respectively. HBsAg serum levels remained very low over the entire period of observation (median 9 months, range 3-20), and in four cases fluctuated around the detectability threshold. In all cases, HBV-DNA persisted undetectable, liver function tests (LFTs) remained within the normal range, and neither HBV-related hepatitis nor HCC were observed. No baseline patients' features were found to be significantly associated with the likelihood of HBsAg reappearance after HBIG withdrawal, including the presence of HCC at transplantation.</p><p><strong>Conclusions: </strong>HBIG could be safely withdrawn in HBV mono-infected LT recipients on long-term combination HBIG plus third generation NAs.</p>","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":" ","pages":""},"PeriodicalIF":6.7,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144937022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Telemetric Assessment and Comparison of Regional Colonic Metabolic Activity in Ambulant Healthy Individuals Using pH and Gas‐Sensing Wireless Motility Capsules 使用pH值和气体感应无线运动胶囊遥测评估和比较走动健康个体的局部结肠代谢活动
IF 7.6 1区 医学
Alimentary Pharmacology & Therapeutics Pub Date : 2025-08-27 DOI: 10.1111/apt.70345
Phoebe A. Thwaites, Chu K. Yao, Jasjot Maggo, Francis C. Parker, Emma P. Halmos, Rebecca E. Burgell, Jane G. Muir, Daniel So, Kourosh Kalantar‐Zadeh, Richard B. Gearry, Peter R. Gibson
{"title":"Telemetric Assessment and Comparison of Regional Colonic Metabolic Activity in Ambulant Healthy Individuals Using pH and Gas‐Sensing Wireless Motility Capsules","authors":"Phoebe A. Thwaites, Chu K. Yao, Jasjot Maggo, Francis C. Parker, Emma P. Halmos, Rebecca E. Burgell, Jane G. Muir, Daniel So, Kourosh Kalantar‐Zadeh, Richard B. Gearry, Peter R. Gibson","doi":"10.1111/apt.70345","DOIUrl":"https://doi.org/10.1111/apt.70345","url":null,"abstract":"BackgroundIngestible wireless motility capsules enable locoregional quantification of luminal pH and concentrations of hydrogen and carbon dioxide in the human colon.AimTo evaluate these measures in the colon of healthy adults.MethodsGas‐sensing and pH‐sensing wireless motility capsules were ingested tandemly and repeatedly over time. Measurements were analysed and compared in proximal and distal segments of the colon.ResultsIn paired datasets from 37 participants, colonic pH rose from a median 6.3 (IQR 5.8–6.9) proximally to 7.0 (6.6–7.2) distally (<jats:italic>p</jats:italic> &lt; 0.001). Concentrations of carbon dioxide rose in nearly all participants from 12.7 (9.1–18.6) proximally to 18.8 (11.9–28.1) %.h/h distally (<jats:italic>p</jats:italic> &lt; 0.001) with a positive correlation between proximal and distal colon (<jats:italic>r</jats:italic> = 0.76; <jats:italic>p</jats:italic> &lt; 0.001). Hydrogen concentrations showed widely varied proximal‐to‐distal gradients with an increase in 69% of participants, but no correlation between proximal and distal colon measures. No significant correlations between colonic pH, hydrogen concentrations, and carbon dioxide concentrations were observed. Comparison of hydrogen and carbon dioxide concentrations between tandem gas‐sensing capsules by Bland–Altman analysis (<jats:italic>n</jats:italic> = 24) showed minimal (&lt; 1.2%) bias for both measures, and gas metrics on repeat ingestion were similar (<jats:italic>n</jats:italic> = 20). However, there was greater variance in the distal colon.ConclusionsBoth wireless motility capsules evaluate different yet complementary aspects of colonic fermentation. Carbon dioxide concentrations that most likely reflect overall microbial metabolic activity were consistently greater distally, while proximal‐to‐distal gradients in hydrogen concentrations varied, likely due to inter‐subject variations in dietary carbohydrate and/or methanogenesis. Luminal pH poorly reflects carbohydrate fermentation in the distal colon.Trial RegistrationACTRN12619001219178 and ACTRN12622000422729","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"23 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144905841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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