Hepatitis C virus （HCV） can develop into liver cirrhosis or hepatocellular carcinoma， imposing a heavy burden on the patient’s family and the society. Hepatitis C is one of the major public threats for humans， and eliminating hepatitis C is a common goal of all humans. Direct-acting antiviral agents （DAAs） are currently a relatively safe treatment regimen for hepatitis C that can reach a relatively high cure rate and can target different HCV genotypes， making it possible to eliminate HCV infection. China actively promotes the clinical application of DAAs， accelerates drug approval， improves the accessibility of DAAs， and strengthens population intervention. National Medical Insurance Administration has gradually included DAAs in the national medical insurance directory， providing strong support for eliminating HCV infection. In response to the WHO’s goal of eliminating viral hepatitis as a public health hazard by 2030， China has successively released national strategic plans and action plans in recent years， making significant achievements in HCV infection elimination， forming a joint prevention and control system across multiple sectors of the society， and ultimately achieving the goal of eliminating HCV infection. With a focus on the current status of HCV infection in China and prominent prevention and control strategies， this article analyzes and summarizes the practical process of the prevention， control， and micro-elimination of HCV infection， in order to provide a policy reference for carrying out HCV elimination in China and help to achieve the goal of comprehensive elimination of HCV infection.

Objective:To evaluate the predictive value of serum 25-hydroxyvitamin D (25(OH)D) level for the clinical response and imaging response to anal fistula in patients with perianal fistulizing Crohn′s disease (PFCD) treated with ustekinumab (UST).Methods:From October 1, 2021 to June 30, 2023, 80 patients with active PFCD who received UST treatment at the Second Affiliated Hospital of Wenzhou Medical University were retrospectively collected. Harvey-Bradshaw index (HBI) was applied to evaluate the clinical activity of PFCD patients. Perianal disease activity index (PDAI) were used to evaluate the clinical outcomes of anal fistula and pelvic magnetic resonance imaging (MRI) were used to evaluate the imaging outcomes of anal fistula. Serum 25(OH)D levels were examined at week 0, 8, 16, and 24 after UST treatment. Binary logistic regression models were performed to analyze the relationship between the baseline serum 25(OH)D level and the clinical pathological characteristics. And the correlation between the serum 25(OH)D level and the clinical response to anal fistula at week 8 after UST treatment was analyzed. The relationship between clinical response and imaging response to anal fistula at week 24 was also analyzed. R software was employed to draw nomograms and calculate the C-index. Independent sample t test and chi-square test were used for statistical comparison. Results:Multifactorial binary logistic regression analysis showed that the baseline level of serum 25(OH)D was independently correlated with the baseline HBI and baseline PDAI in PFCD patients ( OR=1.45, 95% confidence interval (95% CI) 1.08 to 1.95, P=0.014; OR=1.39, 95% CI 1.01 to 1.92, P=0.042). At week 8 after UST treatment, the serum 25(OH)D level of patients with clinical response to fistula was higher than that of patients without clinical response ((21.77±6.17) μg/L vs. (16.72±6.39) μg/L), while the baseline PDAI was lower than that of patients without response (6.88±2.15 vs. 8.06±2.14), and the proportions of patients with previous failure of biologic therapy and with complex anal fistula were also lower than those of patients without response (42.4%, 14/33 vs. 66.0%, 31/47; 57.6%, 19/33 vs. 78.7%, 37/47), and the differences were statistically significant ( t=3.53 and 2.43, χ2=4.36 and 4.13; P=0.002, 0.022, 0.039 and 0.045). At week 24 after UST treatment, the serum level of 25(OH)D in patients with imaging response was higher than that in patients without response ((22.48±5.81) μg/L vs. (16.66±6.34) μg/L), and the proportion of patients with previous failure of biologic therapy and the proportion of patients with complex anal fistula was lower than that in patients without response (40.0%, 20/50 vs. 12/15; 60.0%, 30/50 vs. 14/15), and all the differences were statistically significant ( t=3.33, χ2=7.39 and 5.86; P=0.004, 0.011 and 0.038). Multifactorial binary logistic regression model analysis showed that the average serum 25(OH)D level and previous failure of biological therapy were 2 independent factors of clinical response to anal fistula at week 8 after UST treatment ( OR=1.11, 95% CI 1.02 to 1.21, P=0.012; OR=0.34, 95% CI 0.12 to 0.97, P=0.043), which were also 2 independent factors of clinical response to anal fistula ( OR=1.14, 95% CI 1.05 to 1.24, P=0.002; OR=0.30, 95% CI 0.11 to 0.89, P=0.029) and imaging response to anal fistula ( OR=1.20, 95% CI 1.05 to 1.36, P=0.006; OR=0.11, 95% CI 0.02 to 0.58, P=0.009) at week 24 after UST treatment. The nomograms showed the C-indexes of the clinical response to anal fistula at week 8 and week 24 after UST treatment were 0.78 (95% CI 0.68 to 0.89) and 0.76 (95% CI 0.64 to 0.87), respectively. The C-index of imaging response at week 24 after UST treatment was 0.85 (95% CI 0.76 to 0.95). Conclusions:In PFCD patients treated with UST, serum 25(OH)D levels and previous failure of biological therapy may independently affect the clinical response to anal fistula at week 8 and 24 after UST treatment, as well as the imaging response to anal fistula at week 24 after UST treatment.

Pyroptosis is a newly discovered kind of cell death modality that, due to its association with innate immunity, plays a crucial role in cytolysis and inflammatory cytokine release during host defense against infection. In recent years, studies have shown that pyroptosis plays an important role in the occurrence and development of liver diseases. This article introduces and elaborates on the most recent research progress on pyroptosis in liver diseases based on the morphological features, molecular and pathophysiological mechanisms.

Chronic hepatitis D is a kind of severe viral hepatitis caused by co-infection with hepatitis D virus (HDV) and hepatitis B virus (HBV) or infection with HDV on the ground of HBV infection. Patients with hepatitis D who are infected with HBV often have faster disease progression and a worse prognosis. However, the public and clinicians have always paid little attention to chronic hepatitis D. Coupled with the limitations of detection methods and the absence of a screening system, the HDV screening rate in various regions of the world is at a low level. Consequently, the enthusiasm for screening, diagnosis, and treatment has been further reduced by the inadequate effectiveness of previous treatment methods. In recent years, progress has been made in the research and development of anti-HDV drugs, and a variety of drugs have already entered the clinical trial stage, and some have already been approved for commercialization in specific parts of the world. In this context, the world is also actively exploring effective ways to increase the HDV screening rate. The reflex test model can effectively raise the HDV screening rate and serve as a reference for HDV screening in other countries and regions, as demonstrated by studies conducted in the United Kingdom, France, and Spain, among others. This article will review the detection methods, screening, diagnosis, and treatment current status, as well as the progress in drug research and development, in order to help clinical physicians understand chronic HDV diagnosis and treatment.

Objective:We conducted a real-world multi-center clinical study with a large sample size to comprehensively evaluate the performance of three commercial hepatitis C virus (HCV) core antigen assays. The study aimed to evaluate the performance for their use in HCV infection screening, and to provide clues for further improving the sensitivity and specificity of the assays.Methods:Key performance indicators including the lower limit of detection (LOD), diagnostic sensitivity, and specificity of three HCV antigen assays (the Architect, Laibo, and ChemClin HCV core antigen assays) were evaluated using commercial seroconversion panels reflecting early HCV infection and clinical routine serum samples of outpatients and inpatients from 3 tertiary hospitals from January 2018 to April 2022. Factors that affect the performance indicators were further investigated.Results:The window period for detecting HCV infection with the three antigen assays was equal to or slightly longer than that of the RNA assay, but all are shorter than that of the anti-HCV assay. There was a good linear positive correlation between HCV core antigen and HCV RNA levels in treatment naive patients with hepatitis C ( r=0.90, P<0.01). For the most common genotype 1b strain in China, the LOD of the three HCV assays were equivalent to 531 IU/ml (Architect), 3,698 IU/mL (Laibo), and 4,624 IU/mL (ChemClin) HCV RNA, respectively. Due to the skewed distribution of HCV RNA levels in treatment-naive hepatitis C patients, more than 95% of the patients had viral loads higher than 6 166 IU/ml. Therefore, the three HCV antigens assays still maintained a satisfactory diagnostic sensitivity (94.33%-99.40%). Among 54 immunodeficient patients (leukemia patients) with HCV infection, 9% (5/54) had negative anti-HCV results, while the HCV antigen assays found all these infectors. Through further experiments, we revealed the amino acid polymorphism in the core region of genotype 3 strain impaired the sensitivity of all three HCV antigen assays. In addition, the sensitivity of the two domestic assays was impaired by anti-HCV antibodies in the serum. The specificity of HCV antigen assays for diagnosing hepatitis C is 99.94% to 99.98%. The rheumatoid factors, autoantibodies, and other unknown interference substances can lead to a small number of low level, "false positive" antigen results. Conclusions:HCV core antigen assay may be used as a satisfactory approach of infection screening, especially for the immunodeficient patents. However, the sensitivity and specificity of the assays are influenced by multiple factors, which should be further improved.

The Infectious Diseases Society of America and the American Association for the Study of Liver Diseases have collaboratively developed evidence-based guidance regarding the diagnosis， management， and treatment of hepatitis C virus （HCV） infection since 2013. A panel of clinicians and investigators with extensive expertise in infectious diseases or hepatology specific to HCV infection periodically reviews related evidence and update existing recommendations or introduce new recommendations based on such evidence. This update focuses on the changes to the guidance since the update in 2020， including recommendations for extensive universal screening， simplified treatment and testing regimens， treatment of poor compliance， and management of unique and key populations such as children aged <3 years and patients undergoing transplantation.

Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition) are updated and revised based on the research advances in chronic hepatitis B virus infection in China and globally and the previous editions of the guidelines. This article introduces the updates in natural history and the noninvasive diagnosis and treatment of fibrosis. In particular, the guidelines further expand the indications for patients with chronic hepatitis B virus infection, clearly defines the selection of the population benefiting from interferon therapy, and strictly limits the standard of oral nucleos(t)ide analogues. Meanwhile, the guidelines also recommend more active treatment of patients with low-level viremia and children in the immune-tolerant phase. The new edition of the guidelines will provide an important basis for expanding the screening for hepatitis B virus infection, improving diagnostic rate, optimizing treatment regimens, and standardizing clinical management in China.

Fatty liver disease has undergone a major name change, with metabolic dysfunction-associated fatty liver disease (MASLD) replacing nonalcoholic fatty liver disease. The definition of MASLD no longer requires the exclusion of other co-existing liver diseases but instead associates hepatic steatosis with overweight/obesity, type 2 diabetes mellitus, or metabolic disorders and clearly defines the amount of alcohol consumption. The new definition also introduces the concepts of metabolic-related alcoholic liver disease and cryptogenic fatty liver disease. These changes will bring new challenges and opportunities for the design of clinical trials of fatty liver disease drugs and the selection of target populations.

Objective:The authenticity and accuracy of medical device related clinical trial data is crucial for the efficacy and safety of tested products. This article analyzed issues identified during previous data inspections of medical device clinical trials in our hospital, summarized experiences and findings, and proposed solutions.Methods:According to the " Medical Device Clinical Trial Inspection Points and Judgment Principles" , this study retrospectively analyzed the data inspection of medical device clinical trials in our hospital since 2016, summarized and analyzed the common issues identified.Results:A total number of six data inspections on medical device clinical trials were carried out in our hospital, during which 30 findings were identified. These findings include 4 items of pre-trial preparation, 2 items of patient rights protection, 7 items of trial processes, 12 items of records and reporting, as well as 5 items of experimental medical device management.Conclusions:The completeness, accuracy and consistency of clinical trial records in clinical trials of devices in our hospital have a lot space for improvement. And there is still room for improvement in the compliance to the protocol and the management of medical devices during the trial process. Based on the common findings, our drug clinical trial center will strengthen training and quality control, improve informatization and centralized management, and emphasize the importance of records. Through that the accuracy and authenticity of trial data for medical devices, and the credibility and objectiveness of trial results would be assured.

Objective:By strengthening the management of external provision of data generated by clinical trials in medical institutions, to improve the effectiveness of supervision of human genetic resource information, and to promote the legal sharing and effective use of data.Methods:Analyzed problems identified in filing human genetic resource information in clinical trials since July 1, 2019, put forward possible solutions and suggestions.Results:Main problems were identified in external provision of human genetic resource information, including the specification and time limit of external provision of information, the information recipient, the storage location and the final disposal method of information.Conclusions:Hospital and regulatory authority need to carry out more tailored training, optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.