Journal of Hepatology最新文献

{"title":"Patient-reported outcomes in chronic hepatitis delta: An exploratory analysis of the phase III MYR301 trial of bulevirtide.","authors":"Maria Buti, Heiner Wedemeyer, Soo Aleman, Vladimir Chulanov, Viacheslav Morozov, Olga Sagalova, Tatiana Stepanova, Robert G Gish, Andrew Lloyd, Ankita M Kaushik, Vithika Suri, Dmitry Manuilov, Anu O Osinusi, John F Flaherty, Pietro Lampertico","doi":"10.1016/j.jhep.2024.06.031","DOIUrl":"10.1016/j.jhep.2024.06.031","url":null,"abstract":"<p><strong>Background & aims: </strong>Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD.</p><p><strong>Methods: </strong>In an open-label, randomised, phase III trial, 150 patients with CHD and compensated liver disease were stratified by cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks. HRQoL was evaluated by the following patient-reported outcome instruments at baseline, 24 weeks, and 48 weeks: EQ-5D-3L, Hepatitis Quality of Life Questionnaire, and Fatigue Severity Scale.</p><p><strong>Results: </strong>Patient characteristics and HRQoL scores were balanced at baseline between the treatment (2 mg, n = 49; 10 mg, n = 50) and control (n = 51) groups. Patients receiving 2 mg bulevirtide reported significant improvements compared with controls on the Hepatitis Quality of Life Questionnaire domains of role physical, hepatitis-specific limitations, and hepatitis-specific health distress. Numerically higher scores for general health, hepatitis-specific limitations, and hepatitis-specific health distress domains were reported by patients with cirrhosis who received bulevirtide vs. controls. Fatigue Severity Scale scores remained stable across treatment groups throughout. At week 48, patients in the 2 mg group showed greater mean improvement from baseline in health status compared with controls on the EQ-5D-3L visual analogue scale.</p><p><strong>Conclusion: </strong>Patient-reported outcomes indicate that 48-week treatment with bulevirtide monotherapy may improve aspects of HRQoL in patients with CHD.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov Identifier, NCT03852719.</p><p><strong>Impact and implications: </strong>Bulevirtide 2 mg is the only approved treatment for patients with chronic hepatitis delta (CHD) in the EU. Patients with CHD have worse quality of life scores than those with chronic hepatitis B. Bulevirtide treatment for 48 weeks reduced HDV RNA and alanine aminotransferase levels and was well tolerated among patients with CHD. For the first time, this study shows that patients who received bulevirtide therapy for 48 weeks reported improvements in physical and hepatitis-related quality of life domains compared with those who did not receive therapy (control group).</p>","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"28-36"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141620132","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":"Pre-transplant immune checkpoint inhibitor use: The intersection between medicine, surgery and pharmacy.","authors":"David M Salerno, Tara Shertel, Robert S Brown","doi":"10.1016/j.jhep.2024.07.022","DOIUrl":"10.1016/j.jhep.2024.07.022","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e62-e63"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792599","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":"High prevalence of steatotic liver disease and fibrosis in the general population: A large prospective study in China.","authors":"Shanghao Liu, Heng Wan, Ling Yang, Jie Shen, Xiaolong Qi","doi":"10.1016/j.jhep.2024.07.026","DOIUrl":"10.1016/j.jhep.2024.07.026","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e23-e25"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141860032","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":"Hs-CRP and HOMA-IR: Include them in the MASLD definition, or treat them as mediators between MASLD and atherosclerotic cardiovascular disease?","authors":"Heng Wan, Zihao Gui, Lan Liu, Ningjian Wang, Jie Shen","doi":"10.1016/j.jhep.2024.08.005","DOIUrl":"10.1016/j.jhep.2024.08.005","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e26-e28"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008891","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":"Reply to: \"Is liver fibrosis more advanced in MetALD than in MASLD?\"","authors":"Joo Hyun Oh, Dae Won Jun","doi":"10.1016/j.jhep.2024.09.024","DOIUrl":"10.1016/j.jhep.2024.09.024","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e58-e59"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142348127","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":"Should the new EASL-EASD-EASO Clinical Practice Guidelines on MASLD recommend pioglitazone as a MASH-targeted pharmacotherapy?","authors":"Wellington S Silva Júnior, Andrei C Sposito, Amélio Godoy-Matos","doi":"10.1016/j.jhep.2024.06.034","DOIUrl":"10.1016/j.jhep.2024.06.034","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e21-e22"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544924","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":"Functional cure of hepatitis B in patients with cancer undergoing immune checkpoint inhibitor therapy.","authors":"Hsien-Chen Mon, Pei-Chang Lee, Yi-Ping Hung, Ya-Wen Hung, Chi-Jung Wu, Chieh-Ju Lee, Chen-Ta Chi, I-Cheng Lee, Ming-Chih Hou, Yi-Hsiang Huang","doi":"10.1016/j.jhep.2024.07.018","DOIUrl":"10.1016/j.jhep.2024.07.018","url":null,"abstract":"<p><strong>Background & aims: </strong>Immune checkpoint inhibitors (ICIs) can restore exhausted T-cell immunity not only for cancer treatment but also potentially to cure chronic hepatitis B (CHB). Thus, we aimed to determine the previously unclear impact of ICIs on hepatitis B surface antigen (HBsAg) seroclearance in patients with cancer.</p><p><strong>Methods: </strong>Consecutive patients with cancer from 2016 to 2020 (cohort 1, n = 118), and hepatocellular carcinoma from 2020 to 2022 (cohort 2, n = 44, as validation) receiving ICIs and positive for HBsAg were retrospectively recruited. An additional HBV-HCC cohort (cohort 3, n = 85) not receiving ICIs served as a control group. Factors associated with HBsAg loss or a HBsAg decline >1 log were analyzed.</p><p><strong>Results: </strong>With median follow-up of 17.5 months, 8 (6.8%) patients in cohort 1 and 4 (9.1%) in cohort 2 achieved HBsAg seroclearance, and an additional four in cohort 1 and one in cohort 2 had a HBsAg decline >1 log. In multivariate analysis, HBsAg <100 IU/ml was associated with HBsAg seroclearance (hazard ratio 6.274, p = 0.028). In the validation cohort, the cumulative incidences of HBsAg loss at months 12 and 24 were 13.0% and 38.4%, respectively, for baseline HBsAg <100 IU/ml, which were significantly higher than those in the control group (p = 0.0267). No case in cohort 3 achieved HBsAg loss within 24 months. Of the 17 cases who achieved HBsAg loss or a decline >1 log, 16 (94.1%) received nucleos(t)ide analogue treatment. The median time to HBsAg loss or HBsAg decline was 16.5 (range 9.6 to 27.5) months.</p><p><strong>Conclusions: </strong>ICIs may accelerate HBsAg seroclearance in patients with cancer and baseline HBsAg <100 IU/ml. This finding provides important information for the design of future trials evaluating the ability of ICIs to induce functional cure in patients with CHB.</p><p><strong>Impact and implications: </strong>Immune checkpoint inhibitors (ICIs) can restore exhausted T-cell immunity not only for cancer treatment but also potentially to cure chronic hepatitis B. Functional cure of hepatitis B was observed in patients with cancer or HCC undergoing ICI treatment, and the cumulative incidence of HBsAg loss was higher compared with controls without ICIs. ICIs may accelerate the HBsAg loss in patients with baseline HBsAg levels <100 IU/ml. This finding provides important information for the design of future ICI trials evaluating the ability of ICIs to induce functional cure in patients with CHB.</p>","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"51-61"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141860031","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":"Porto-sinusoidal vascular liver disorder with portal hypertension: Natural history and long-term outcome.","authors":"Marta Magaz, Heloïse Giudicelli-Lett, Juan G Abraldes, Oana Nicoară-Farcău, Fanny Turon, Neil Rajoriya, Ashish Goel, Karlien Raymenants, Sophie Hillaire, Luis Téllez, Laure Elkrief, Bogdan Procopet, Lara Orts, Filipe Nery, Akash Shukla, Hélène Larrue, Helena Degroote, Victoria Aguilera, Elba Llop, Laura Turco, Federica Indulti, Stefania Gioia, Giulia Tosetti, Niccolò Bitto, Chiara Becchetti, Edilmar Alvarado, Cristina Roig, Raquel Diaz, Michael Praktiknjo, Anna-Lena Konicek, Pol Olivas, José Ignacio Fortea, Helena Masnou, Ángela Puente, Alba Ardèvol, Carmen A Navascués, Marta Romero-Gutiérrez, Bernhard Scheiner, Georg Semmler, Mattias Mandorfer, Filipe Damião, Anna Baiges, Asunción Ojeda, Macarena Simón-Talero, Carlos González-Alayón, Alba Díaz, Ángeles García-Criado, Andrea De Gottardi, Manuel Hernández-Guerra, Joan Genescà, Nicolas Drilhon, Carlos Noronha Ferreira, Thomas Reiberger, Manuel Rodríguez, Rosa María Morillas, Javier Crespo, Jonel Trebicka, Rafael Bañares, Càndid Villanueva, Annalisa Berzigotti, Massimo Primignani, Vincenzo La Mura, Oliviero Riggio, Filippo Schepis, Xavier Verhelst, José Luis Calleja, Christophe Bureau, Agustín Albillos, Frederik Nevens, Virginia Hernández-Gea, Dhiraj Tripathi, Pierre-Emmanuel Rautou, Juan Carlos García-Pagán","doi":"10.1016/j.jhep.2024.07.035","DOIUrl":"10.1016/j.jhep.2024.07.035","url":null,"abstract":"<p><strong>Background & aims: </strong>Current knowledge of the natural history of patients with porto-sinusoidal vascular disorder (PSVD) is derived from small studies. The aim of the present study was to determine the natural history of PSVD and prognostic factors in a large multicenter cohort of patients.</p><p><strong>Methods: </strong>We performed a retrospective study on patients with PSVD and signs of portal hypertension (PH) prospectively registered in 27 centers.</p><p><strong>Results: </strong>A total of 587 patients were included, median age of 47 years and 38% were women. Four-hundred and one patients had an associated condition, which was graded as severe in 157. Median follow-up was 68 months. At diagnosis, 64% of patients were asymptomatic while 36% had a PH-related complication: PH-related bleeding in 112 patients, ascites in 117, and hepatic encephalopathy in 11. In those not presenting with bleeding, the incidence of first bleeding was 15% at 5 years, with a 5-year rebleeding rate of 18%. The 5-year cumulative incidence of new or worsening ascites was 18% and of developing portal vein thrombosis was 16%. Fifty (8.5%) patients received a liver transplantation and 109 (19%) died, including 55 non-liver-related deaths. Transplant-free survival was 97% and 83% at 1 and 5 years, respectively. Variables independently associated with transplant-free survival were age, ascites, serum bilirubin, albumin and creatinine levels at diagnosis and severe associated conditions. This allowed for the creation of a nomogram that accurately predicted prognosis.</p><p><strong>Conclusions: </strong>The prognosis of PSVD is strongly determined by the severity of the associated underlying conditions and parameters of liver and renal function.</p><p><strong>Impact and implications: </strong>Porto-sinusoidal vascular liver disorder (PSVD) is a rare entity that usually affects young people, frequently causes severe complications of portal hypertension, and may reduce life expectancy. To date, there is scarce information regarding its clinical manifestations, natural history and prognostic factors. The present study, including the largest number of patients with PSVD reported so far, shows that overall, when managed at centers of expertise, the prognosis of patients with PSVD is good, with LT-free survival rates of 83% and 72% at 5 and 10 years, respectively. Presence and severity of an underlying associated condition, presence of ascites, age and bilirubin, albumin and creatinine levels were associated with poor prognosis. These results are important to know for hepatologists. A final model combining these parameters enabled development of a nomogram that predicts prognosis with good discrimination and calibration capacity and can be easily applied in clinical practice.</p>","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"72-83"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055736","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":"Reply to \"The association between primary hypobetalipoproteinemia and hepatic diseases: evidence from genetic studies\".","authors":"Antoine Rimbert, Matthieu Wargny, Bertrand Cariou","doi":"10.1016/j.jhep.2024.09.009","DOIUrl":"10.1016/j.jhep.2024.09.009","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e50-e51"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289143","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":"Reply to: \"Implications of mycophenolate mofetil in a reproductive age patient cohort: Maternal fetal medicine point of view\".","authors":"Charlotte D Slooter, Anna E C Stoelinga, Romée J A L M Snijders","doi":"10.1016/j.jhep.2024.09.006","DOIUrl":"10.1016/j.jhep.2024.09.006","url":null,"abstract":"","PeriodicalId":15888,"journal":{"name":"Journal of Hepatology","volume":" ","pages":"e37-e38"},"PeriodicalIF":26.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289145","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}