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Antiviral Therapy for Chronic Hepatitis B with Mildly Elevated Aminotransferase: A Rollover Study from the TORCH-B Trial. 对转氨酶轻度升高的慢性乙型肝炎患者进行抗病毒治疗:TORCH-B试验的滚动研究。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-17 DOI: 10.3350/cmh.2024.0640
Yao-Chun Hsu, Chi-Yi Chen, Cheng-Hao Tseng, Chieh-Chang Chen, Teng-Yu Lee, Ming-Jong Bair, Jyh-Jou Chen, Yen-Tsung Huang, I-Wei Chang, Chi-Yang Chang, Chun-Ying Wu, Ming-Shiang Wu, Lein-Ray Mo, Jaw-Town Lin

Background & aims: Treatment indications for patients with chronic hepatitis B (CHB) remain contentious, particularly for patients with mild alanine aminotransferase (ALT) elevation. We aimed to evaluate treatment effects in this patient population.

Methods: This rollover study extended a placebo-controlled trial that enrolled non-cirrhotic patients with CHB and ALT levels below two times the upper limit of normal. Following 3 years of randomized intervention with either tenofovir disoproxil fumarate (TDF) or placebo, participants were rolled over to open-label TDF for 3 years. Liver biopsies were performed before and after the treatment to evaluate histopathological changes. Virological, biochemical, and serological outcomes were also assessed (NCT02463019).

Results: Of 146 enrolled patients (median age 47 years, 80.8% male), 123 completed the study with paired biopsies. Overall, the Ishak fibrosis score decreased in 74 (60.2%), remained unchanged in 32 (26.0%), and increased in 17 (13.8%) patients (p<0.0001). The Knodell necroinflammation score decreased in 58 (47.2%), remained unchanged in 29 (23.6%), and increased in 36 (29.3%) patients (p=0.0038). The proportion of patients with an Ishak score ≥ 3 significantly decreased from 26.8% (n=33) to 9.8% (n=12) (p=0.0002). Histological improvements were more pronounced in patients switching from placebo. Virological and biochemical outcomes also improved in placebo switchers and remained stable in patients who continued TDF. However, serum HBsAg levels did not change and no patient cleared HBsAg.

Conclusions: In CHB patients with minimally raised ALT, favorable histopathological, biochemical, and virological outcomes were observed following 3-year TDF treatment, for both treatment-naïve patients and those already on therapy.

背景与目的:慢性乙型肝炎(CHB)患者的治疗指征仍存在争议,尤其是轻度丙氨酸氨基转移酶(ALT)升高的患者。我们旨在评估这一患者群体的治疗效果:这项滚动研究扩展了一项安慰剂对照试验,该试验招募了非肝硬化且 ALT 水平低于正常上限两倍的 CHB 患者。在使用富马酸替诺福韦二吡呋酯(TDF)或安慰剂进行为期3年的随机干预后,参与者转为使用开放标签TDF,为期3年。治疗前后均进行了肝活检,以评估组织病理学变化。还评估了病毒学、生化和血清学结果(NCT02463019):结果:146 名入选患者(中位年龄 47 岁,80.8% 为男性)中,123 人完成了研究并进行了配对活检。总体而言,74 例(60.2%)患者的伊沙克纤维化评分下降,32 例(26.0%)保持不变,17 例(13.8%)患者的评分上升(p结论:在微升高的慢性阻塞性肺病患者中,伊沙克纤维化评分上升的患者占多数:在ALT轻度升高的慢性乙型肝炎患者中,无论是治疗前还是已接受治疗的患者,在接受为期3年的TDF治疗后都能观察到良好的组织病理学、生化和病毒学结果。
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引用次数: 0
Chronic hepatitis B, Extrahepatic Malignancies and the Use of Antiviral Drugs. 慢性乙型肝炎、肝外恶性肿瘤和抗病毒药物的使用。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-17 DOI: 10.3350/cmh.2024.0906
Meng-Che Wu, Shih-Chi Yang, Shuo-Yan Gau
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引用次数: 0
Aberrant fragmentomic features of circulating cell-free mitochondrial DNA enable early detection and prognosis prediction of hepatocellular carcinoma. 循环细胞游离线粒体 DNA 的异常片段组特征可用于肝细胞癌的早期检测和预后预测。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-15 DOI: 10.3350/cmh.2024.0527
Yang Liu, Fan Peng, Siyuan Wang, Huanmin Jiao, Kaixiang Zhou, Wenjie Guo, Shanshan Guo, Miao Dang, Huanqin Zhang, Weizheng Zhou, Xu Guo, Jinliang Xing

Background: Early detection and effective prognosis prediction in patients with hepatocellular carcinoma (HCC) provides an avenue for survival improvement, yet more effective approaches are greatly needed. We sought to develop the detection and prognosis models with ultra-sensitivity and low cost based on fragmentomic features of circulating cell free mtDNA (ccf-mtDNA).

Participants and methods: Capture-based mtDNA sequencing was carried out in plasma cell-free DNA samples from 1168 participants, including 571 patients with HCC, 301 patients with chronic hepatitis B or liver cirrhosis (CHB/LC) and 296 healthy controls (HC).

Results: The systematic analysis revealed significantly aberrant fragmentomic features of ccf-mtDNA in HCC group when compared with CHB/LC and HC groups. Moreover, we constructed a random forest algorithm-based HCC detection model by utilizing ccf-mtDNA fragmentomic features. Both internal and two external validation cohorts demonstrated the excellent capacity of our model in distinguishing early HCC patients from HC and high-risk population with CHB/LC, with AUC exceeding 0.983 and 0.981, sensitivity over 89.6% and 89.61%, and specificity over 98.20% and 95.00%, respectively, greatly surpassing the performance of alpha-fetoprotein (AFP) and mtDNA copy number. We also developed a HCC prognosis prediction model by LASSO-Cox regression to select 20 fragmentomic features, which exhibited exceptional ability in predicting 1-year, 2-year and 3-year survival (AUC = 0.8333, 0.8145 and 0.7958 for validation cohort, respectively).

Conclusions: We have developed and validated a high-performing and low-cost approach in a large clinical cohort based on aberrant ccf-mtDNA fragmentomic features with promising clinical translational application for the early detection and prognosis prediction of HCC patients.

背景:肝细胞癌(HCC)患者的早期检测和有效预后预测为提高生存率提供了一条途径,但目前亟需更有效的方法。我们试图根据循环细胞游离mtDNA(ccf-mtDNA)的片段组学特征开发超灵敏、低成本的检测和预后模型:对1168名参与者的血浆游离细胞DNA样本进行了基于捕获的mtDNA测序,其中包括571名HCC患者、301名慢性乙型肝炎或肝硬化(CHB/LC)患者和296名健康对照组(HC):系统分析显示,与 CHB/LC 组和 HC 组相比,HCC 组的 ccf-mtDNA 片段组特征明显异常。此外,我们还利用ccf-mtDNA片段组学特征构建了基于随机森林算法的HCC检测模型。内部和两个外部验证队列都证明了我们的模型在区分早期HCC患者与HC和CHB/LC高危人群方面的卓越能力,AUC分别超过0.983和0.981,灵敏度分别超过89.6%和89.61%,特异性分别超过98.20%和95.00%,大大超过了甲胎蛋白(AFP)和mtDNA拷贝数。我们还通过LASSO-Cox回归建立了一个HCC预后预测模型,选择了20个片段组特征,该模型在预测1年、2年和3年生存率方面表现出卓越的能力(验证队列的AUC分别为0.8333、0.8145和0.7958):我们基于ccf-mtDNA片段组的异常特征,在大型临床队列中开发并验证了一种高效、低成本的方法,该方法在HCC患者的早期检测和预后预测方面具有广阔的临床转化应用前景。
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引用次数: 0
Correspondence on Editorial regarding "Essential tools for assessing advanced fibrosis in metabolic dysfunction-associated steatotic liver disease". 关于 "评估代谢功能障碍相关脂肪性肝病晚期纤维化的基本工具 "社论的通信。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-15 DOI: 10.3350/cmh.2024.0878
Young Eun Chon, Jung Hwan Yu, Seung Up Kim
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引用次数: 0
Reply to: "Unveiling the distinctive gut microbiota and metabolites in liver cirrhosis and its complications: Novel diagnostic biomarkers". 回复"揭示肝硬化及其并发症中独特的肠道微生物群和代谢物:新的诊断生物标志物"。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-15 DOI: 10.3350/cmh.2024.0872
Satya Priya Sharma, Ki Tae Suk
{"title":"Reply to: \"Unveiling the distinctive gut microbiota and metabolites in liver cirrhosis and its complications: Novel diagnostic biomarkers\".","authors":"Satya Priya Sharma, Ki Tae Suk","doi":"10.3350/cmh.2024.0872","DOIUrl":"https://doi.org/10.3350/cmh.2024.0872","url":null,"abstract":"","PeriodicalId":10275,"journal":{"name":"Clinical and Molecular Hepatology","volume":null,"pages":null},"PeriodicalIF":14.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459440","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
Reply to: Correspondence on Editorial regarding "Genetically modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting". 回复:关于 "临床环境中针对乙型肝炎表面抗原阳性肝细胞和肝细胞癌病变的转基因重定向 T 细胞 "社论的通信。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-11 DOI: 10.3350/cmh.2024.0867
Antonio Bertoletti, Anthony T Tan
{"title":"Reply to: Correspondence on Editorial regarding \"Genetically modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting\".","authors":"Antonio Bertoletti, Anthony T Tan","doi":"10.3350/cmh.2024.0867","DOIUrl":"https://doi.org/10.3350/cmh.2024.0867","url":null,"abstract":"","PeriodicalId":10275,"journal":{"name":"Clinical and Molecular Hepatology","volume":null,"pages":null},"PeriodicalIF":14.0,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399579","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
Metabolic dysfunction-associated steatotic liver disease exhibits sex-specific microbial heterogeneity within intestinal compartments. 代谢功能障碍相关性脂肪肝在肠道内表现出性别特异性微生物异质性。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-11 DOI: 10.3350/cmh.2024.0359
Carlos Jose Pirola, Maria Silvina Landa, Mariano Schuman, Silvia Inés García, Adrian Salatino, Silvia Sookoian

Background: Evidence suggests that the gastrointestinal microbiome plays a significant role in the biology of metabolic dysfunction-associated steatotic liver disease (MASLD). However, it remains unclear whether disparities in the gut microbiome across intestinal tissular compartments between the sexes lead to MASLD pathogenesis.

Methods: Sex-specific analyses of microbiome composition in two anatomically distinct regions of the gut, the small intestine and colon, were performed using an experimental model of MASLD. The study involved male and female spontaneously hypertensive rats and the Wistar-Kyoto control rat strain, which were fed either a standard chow diet or a high-fat diet for 12 weeks to induce MASLD (12 rats per group). High-throughput 16S sequencing was used for microbiome analysis.

Results: There were significant differences in the overall microbiome composition of male and female rats with MASLD, including variations in topographical gut regions. The beta diversity of the jejunal and colon microbiomes was higher in female rats than in male rats (PERMANOVA p-value=0.001). Sex-specific analysis and discriminant features using LEfSe showed considerable variation in bacterial abundance, along with distinct functional properties, in the jejunum and colon of animals with MASLD. Significantly elevated levels of lipopolysaccharide and protein expression of Toll-like receptor 4 were observed in the livers of male rats with MASLD compared with their female counterparts.

Conclusion: This study uncovered sexual dimorphism in the gut microbiome of MASLD and identified microbial heterogeneity within intestinal compartments. Insights into sex-specific variations in gut microbiome composition could facilitate customised treatment strategies.

背景:有证据表明,胃肠道微生物组在代谢功能障碍相关性脂肪性肝病(MASLD)的生物学过程中发挥着重要作用。然而,目前仍不清楚不同性别肠道微生物组之间的差异是否会导致 MASLD 发病:方法:利用一种 MASLD 实验模型,对小肠和结肠这两个解剖学上截然不同的肠道区域的微生物组组成进行了性别特异性分析。该研究涉及雌雄自发性高血压大鼠和 Wistar-Kyoto 对照品系大鼠,它们被喂食标准饲料或高脂肪饲料 12 周以诱导 MASLD(每组 12 只大鼠)。高通量 16S 测序用于微生物组分析:结果:患有 MASLD 的雌雄大鼠的整体微生物组组成存在明显差异,包括肠道地形区域的差异。雌性大鼠空肠和结肠微生物组的贝塔多样性高于雄性大鼠(PERMANOVA p-value=0.001)。使用 LEfSe 进行的性别特异性分析和判别特征显示,MASLD 动物空肠和结肠中的细菌丰度存在相当大的差异,而且功能特性也各不相同。在患有 MASLD 的雄性大鼠肝脏中观察到的脂多糖和 Toll 样受体 4 蛋白表达水平明显高于雌性大鼠:这项研究发现了MASLD肠道微生物组的性别双态性,并确定了肠道内微生物的异质性。了解肠道微生物组组成的性别特异性变化有助于制定个性化的治疗策略。
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引用次数: 0
Reply: Correspondence: "Transcriptomic signature in hepatocellular carcinoma to predict immunotherapy response." 答复:通讯:"肝细胞癌转录组特征预测免疫疗法反应"。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-11 DOI: 10.3350/cmh.2024.0886
Hiroaki Kanzaki, Yujin Hoshida
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引用次数: 0
Development of risk scores for prognosis prediction among patients with early-stage hepatocellular carcinoma. 为早期肝细胞癌患者的预后预测制定风险评分。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-11 DOI: 10.3350/cmh.2024.0794
Xiping Shen, Ji Wu
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引用次数: 0
Letter regarding "Prevalence of clinically significant liver fibrosis in the general population". 关于 "一般人群中具有临床意义的肝纤维化患病率 "的信函。
IF 14 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-11 DOI: 10.3350/cmh.2024.0887
Wei Feng, Qile Wang, Qingwang Ye
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引用次数: 0
期刊
Clinical and Molecular Hepatology
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