{"title":"The Liver Meeting 2024","authors":"Rob Brierley","doi":"10.1016/s2468-1253(24)00392-3","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00392-3","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Semaglutide for MASH</h2>Semaglutide 2·4 mg once a week demonstrated significantly greater improvements in histology and fibrosis than did placebo in participants with metabolic dysfunction-associated steatohepatitis (MASH) with F2–F3 fibrosis, according to data from the phase 3 ESSENCE trial. Although the trial is ongoing, Phil Newsome (London, UK) presented data from the prespecified interim analysis at week 72 of the first 800 participants, of whom 534 had been randomly assigned to receive semaglutide and 266 had</section></section><section><section><h2>Optimising steroid use in severe alcohol-associated hepatitis</h2>Tapering the dose of corticosteroids is safer and just as efficacious as conventional fixed-dose corticosteroids for severe alcohol-associated hepatitis, according to results from the STASH trial, presented by Anand Kulkarni (Hyderabad, India). Patients with severe alcohol-associated hepatitis were randomly assigned to receive either a fixed-dose or tapering regimen. Patients in each group initially received 40 mg prednisolone a day for 7 days. Patients in the fixed dose group with a Lille</section></section><section><section><h2>CM-101 in primary sclerosing cholangitis</h2>CM-101, an anti-CCL24 monoclonal antibody, exhibited promising activity in patients with primary sclerosing cholangitis and had a safety profile similar to placebo, according to data from the phase 2 SPRING study. In this placebo-controlled trial, presented by Christopher Bowlus (Davis, CA, USA), patients with primary sclerosing cholangitis were randomly assigned to receive either CM-101 at 10 mg/kg (n=25), CM-101 at 20 mg/kg (n=31), or placebo (n=21) every 3 weeks for 15 weeks.</section></section><section><section><h2>VK2809 for steatotic liver disease</h2>The phase 2b VOYAGE trial examined the use of VK2809, a small molecule thyroid hormone receptor beta agonist prodrug that is selectively cleaved in hepatic tissue by cytochrome P450 3A4 to release a pharmacologically active metabolite, in individuals with biopsy-confirmed non-alcoholic fatty liver disease and fibrosis. Participants were randomly assigned to receive placebo or VK2809 at 1 mg/day, 2·5 mg/day, 5 mg/day, or 10 mg/day. Percentage change in MRI-PDFF at 3 months was –56·7% in the</section></section>","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"29 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142809968","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}
{"title":"Correction to Lancet Gastroenterol Hepatol 2024; 9: 718–33","authors":"","doi":"10.1016/s2468-1253(24)00401-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00401-1","url":null,"abstract":"<em>Janssen HLA, Lim Y-S, Lampertico P, et al. Switching to tenofovir alafenamide in patients with virologically suppressed chronic hepatitis B and renal or hepatic impairment: final week 96 results from an open-label, multicentre, phase 2 study.</em> Lancet Gastroenterol Hepatol <em>2024;</em> 9: <em>718–33</em>—In this Article, the label for previous other oral antiviral in figure 3B should have read 0·04; the label for previous tenofovir disproxil fumarate in figure 4C should have read 1·09%; and the label for tenofovir alafenamide in figure 4C should have read 0·28%. These corrections have been made to the online version as of Dec 11, 2024.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"538 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142809530","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}
{"title":"Hypovolaemic phlebotomy to reduce the need for perioperative transfusion: a price worth paying?","authors":"Andreas A Schnitzbauer","doi":"10.1016/s2468-1253(24)00351-0","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00351-0","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"148 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142797535","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}
Guillaume Martel, François Martin Carrier, Christopher Wherrett, Tori Lenet, Katlin Mallette, Karine Brousseau, Leah Monette, Aklile Workneh, Monique Ruel, Elham Sabri, Heather Maddison, Melanie Tokessy, Patrick B Y Wong, Franck Vandenbroucke-Menu, Luc Massicotte, Michaël Chassé, Yves Collin, Michel-Antoine Perrault, Élodie Hamel-Perreault, Jeieung Park, Dean A Fergusson
{"title":"Hypovolaemic phlebotomy in patients undergoing hepatic resection at higher risk of blood loss (PRICE-2): a randomised controlled trial","authors":"Guillaume Martel, François Martin Carrier, Christopher Wherrett, Tori Lenet, Katlin Mallette, Karine Brousseau, Leah Monette, Aklile Workneh, Monique Ruel, Elham Sabri, Heather Maddison, Melanie Tokessy, Patrick B Y Wong, Franck Vandenbroucke-Menu, Luc Massicotte, Michaël Chassé, Yves Collin, Michel-Antoine Perrault, Élodie Hamel-Perreault, Jeieung Park, Dean A Fergusson","doi":"10.1016/s2468-1253(24)00307-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00307-8","url":null,"abstract":"<h3>Background</h3>Blood loss and subsequent red blood cell transfusions are common in liver surgery. Hypovolaemic phlebotomy is associated with decreased red blood cell transfusion in observational studies. This trial aimed to investigate whether hypovolaemic phlebotomy is superior to usual care in reducing red blood cell transfusions in patients undergoing liver resection.<h3>Methods</h3>PRICE-2 was a multicentre, single-blind, superiority randomised controlled trial. Patients at a higher risk of blood loss undergoing liver resection for any indication at four Canadian academic tertiary-care hospitals were randomised to receive hypovolaemic phlebotomy or usual care. Hypovolaemic phlebotomy consisted of the removal of 7–10 mL/kg of whole blood, without volume replacement, before liver transection. Patients were randomised centrally using permuted blocks of randomly variable length, stratified by centre. The randomisation sequence was computer-generated by an independent statistician. Surgeons, patients, and outcome assessors were masked to treatment allocation. The primary outcome was perioperative red blood cell transfusion to 30 days post-randomisation, analysed in all randomly assigned patients who underwent liver resection. PRICE-2 trial was registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT03651154</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) and is completed.<h3>Findings</h3>Between Oct 1, 2018, and Jan 13, 2023, 486 individuals were randomly assigned to receive hypovolaemic phlebotomy (n=245) or usual care (n=241). 22 individuals in the hypovolaemic phlebotomy group and 18 in the usual care group did not undergo liver resection and were thus excluded from the primary analysis population. 223 patients were included in the hypovolaemic phlebotomy group (mean age 61·4 years [SD 13·0]; 137 [61%] men) and 223 in the control group (62·1 years [12·1]; 114 [51%]). 17 (8%) of 223 patients allocated to hypovolaemic phlebotomy and 36 (16%) of 223 patients allocated to usual care had a perioperative red blood cell transfusion by 30 days (difference –8·8 percentage points [95% CI –14·8 to –2·8]; adjusted risk ratio [aRR] 0·47 [95% CI 0·27 to 0·82]). Severe complications to 30 days occurred in 37 (17%) patients allocated to hypovolaemic phlebotomy and 36 (16%) allocated to usual care (aRR 1·06 [95% CI 0·70–1·61]). Overall complications to 30 days occurred in 135 (61%) of 223 patients allocated to hypovolaemic phlebotomy and 116 (52%) of 223 patients allocated to usual care (1·08 [0·92–1·25]). There was no postoperative mortality to 90 days.<h3>Interpretation</h3>In p","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"234 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142797382","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}
Serena Porcari, Benjamin H Mullish, Francesco Asnicar, Siew C Ng, Liping Zhao, Richard Hansen, Paul W O'Toole, Jeroen Raes, Georgina Hold, Lorenza Putignani, Christian Lodberg Hvas, Georg Zeller, Omry Koren, Hein Tun, Mireia Valles-Colomer, Maria Carmen Collado, Monika Fischer, Jessica Allegretti, Tariq Iqbal, Benoit Chassaing, Gianluca Ianiro
{"title":"International consensus statement on microbiome testing in clinical practice","authors":"Serena Porcari, Benjamin H Mullish, Francesco Asnicar, Siew C Ng, Liping Zhao, Richard Hansen, Paul W O'Toole, Jeroen Raes, Georgina Hold, Lorenza Putignani, Christian Lodberg Hvas, Georg Zeller, Omry Koren, Hein Tun, Mireia Valles-Colomer, Maria Carmen Collado, Monika Fischer, Jessica Allegretti, Tariq Iqbal, Benoit Chassaing, Gianluca Ianiro","doi":"10.1016/s2468-1253(24)00311-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00311-x","url":null,"abstract":"There is growing interest in the potential exploitation of the gut microbiome as a diagnostic tool in medicine, but evidence supporting its clinical usefulness is scarce. An increasing number of commercial providers offer direct-to-consumer microbiome diagnostic tests without any consensus on their regulation or any proven value in clinical practice, which could result in considerable waste of individual and health-care resources and potential drawbacks in the clinical management of patients. We convened an international multidisciplinary expert panel to standardise best practices of microbiome testing for clinical implementation, including recommendations on general principles and minimum requirements for their provision, indications, pre-testing protocols, method of analyses, reporting of results, and potential clinical value. We also evaluated current knowledge gaps and future directions in this field. We aimed to establish a framework to regulate the provision of microbiome testing and minimise the use of inappropriate tests and pave the way for the evidence-based development and use of human microbiome diagnostics in clinical medicine.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"3 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142782378","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}
{"title":"Does filgotinib work for Crohn's disease?","authors":"Mark Andrew Ainsworth","doi":"10.1016/s2468-1253(24)00304-2","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00304-2","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"4 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142760073","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}
Séverine Vermeire, Stefan Schreiber, David T Rubin, Geert D'Haens, Walter Reinisch, Mamoru Watanabe, Rajiv Mehta, Xavier Roblin, Ian Beales, Piotr Gietka, Toshifumi Hibi, Ihor Hospodarskyy, Timothy Ritter, Mark C Genovese, Paul Kwon, Eva Santermans, Franck-Olivier Le Brun, Rahul Barron, Tomasz Masior, Silvio Danese
{"title":"Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial","authors":"Séverine Vermeire, Stefan Schreiber, David T Rubin, Geert D'Haens, Walter Reinisch, Mamoru Watanabe, Rajiv Mehta, Xavier Roblin, Ian Beales, Piotr Gietka, Toshifumi Hibi, Ihor Hospodarskyy, Timothy Ritter, Mark C Genovese, Paul Kwon, Eva Santermans, Franck-Olivier Le Brun, Rahul Barron, Tomasz Masior, Silvio Danese","doi":"10.1016/s2468-1253(24)00272-3","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00272-3","url":null,"abstract":"<h3>Background</h3>There is a need for efficacious therapies for patients with Crohn's disease that are better tolerated and more durable than available treatments. We aimed to evaluate the efficacy and safety of filgotinib, an oral Janus kinase 1 preferential inhibitor, for treating Crohn's disease.<h3>Methods</h3>This phase 3, double-blind, randomised, placebo-controlled trial was conducted in 371 centres in 39 countries. Eligible patients were aged 18–75 years with moderately to severely active Crohn's disease for at least 3 months before enrolment. Patients were enrolled into one of two induction studies on the basis of their experience with biological agents (induction study A included biologic-naive and later biologic-experienced patients and induction study B included biologic-experienced patients). In both induction studies, patients were randomly assigned (1:1:1), using an interactive web response system, to receive oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily for 11 weeks. Patients who received filgotinib and had two-item patient-reported outcome (PRO2) clinical remission or an endoscopic response at week 10 were re-randomised (2:1) to receive their induction dose or placebo orally, once daily to the end of week 58 in the maintenance study. Co-primary endpoints were PRO2 clinical remission and an endoscopic response at week 10 (induction studies) and week 58 (maintenance study). PRO2 clinical remission was defined as an abdominal pain subscore of not more than 1 and a liquid or very soft stool frequency subscore of not more than 3 (from eDiary data) and endoscopic response was defined as a reduction of at least 50% in Simple Endoscopic Score for Crohn's disease from induction baseline (from central reading of endoscopy). For the induction studies, efficacy was assessed in all randomly assigned patients who received at least one dose of study drug. For the maintenance study, efficacy was assessed in all patients from either filgotinib treatment group in the induction studies who reached PRO2 clinical remission or an endoscopic response at week 10, and who were re-randomised and received at least one dose of study drug in the maintenance study. Patients who received placebo throughout the induction and maintenance studies were not included in the full analysis set for the maintenance study. Safety was assessed in all patients who received at least one dose of study drug. This trial is complete and is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT02914561</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>.<h3>Findings</h3>Between Oct 31,","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"100 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142760074","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}