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lyophilized hepatitis-B human immunoglobulin

✓ Approved

Tonrol Bio-Pharmaceutical · 多克隆抗体 · 多克隆抗体

什么是 lyophilized hepatitis-B human immunoglobulin？

lyophilized hepatitis-B human immunoglobulin 是一种多克隆抗体，由Tonrol Bio-Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

公司Tonrol Bio-Pharmaceutical
药物类别多克隆抗体, 疫苗, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Tonrol Bio-Pharmaceutical

治疗适应症

lyophilized hepatitis-B human immunoglobulin 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedBMC public health2026-10-27

Communicating hepatitis B: a content, readability and suitability assessment of Australian hepatitis B patient resources.

Ahad Marvad M, Wallace Jack J, Richmond Jacqueline J, Moussa Dina D et al.

Globally, 254 million people are chronically infected with the hepatitis B virus and over 200,000 people in Australia are living with chronic hepatitis B. Over 70% of people living with hepatitis B in Australia are born overseas, therefore the communities affected by hepatitis B are culturally and linguistically diverse. Given the risk of cirrhosis and liver cancer, it is essential that people with hepatitis B are engaged in care and ongoing monitoring. This study evaluates the content, readability, and suitability of Australian hepatitis B education resources. An inductive content analysis identified the main concepts covered in resources, readability was assessed using three readability calculations, and the suitability of materials tool was used to assess the suitability of resources. Three categories were developed from the content analysis: structure and form of resources, presentation of biomedical information, and emphasis on treatment and prevention. Most resources did not meet the readability level requirement recommended in Australia for low literacy resources. All resources were deemed adequate based on scores from the suitability of materials assessment. Involvement of key populations affected should continue to be supported for the conceptualisation and design of hepatitis B education materials.

PMID 42934603
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PubMedAustralian prescriber2026-10-27

Hepatitis B update: enabling progress towards elimination.

Davies Jane J, Capati Marilou M, Allard Nicole N

Hepatitis B is a common vaccine-preventable and treatable condition. Chronic hepatitis B is often asymptomatic and can be missed if the diagnosis is not actively considered. The World Health Organization and the Australian Government have committed to eliminate hepatitis B as a public health threat by 2030. The tools required to achieve this are available: an effective vaccine, accurate blood tests for diagnosis and monitoring, effective antiviral treatments and access to ultrasound to enable early diagnosis of hepatocellular carcinoma. Risk-based testing approaches are not effective enough to enable Australia to achieve elimination targets; hence, the Fourth National Hepatitis B Strategy 2025-2030 calls for population-wide testing to identify hepatitis B status. Chronic hepatitis B is a lifelong disease that requires long-term monitoring and follow-up irrespective of the stage of disease or whether an individual is taking antiviral treatment. Most healthcare for people living with chronic hepatitis B can be provided in primary care. All medical practitioners and authorised nurse practitioners can now prescribe antiviral therapy for hepatitis B; additional accreditation is no longer required. Holistic care includes the provision of resources in a person's preferred language, peer and cultural support workers, access to a long-term effective model of care, and appropriate monitoring. Continuity of healthcare providers is desirable and an important enabler of sustained engagement in care.

PMID 42935728
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PubMedPharmaceuticals (Basel, Switzerland)2026-10-27

MDL-001: An Oral, Direct-Acting Broad-Spectrum Antiviral for Influenza-like Illness (ILI) and Chronic Hepatitis In Vivo.

Woods Virgil V, Umansky Tyler T, Russell Sean M SM, Goodman Asha A et al.

Background/Objectives: Endemic viral respiratory illnesses caused by influenza, RSV, and coronaviruses impose a global disease burden of hundreds of millions of infections and hundreds of thousands of deaths annually. Chronic hepatitis B and C infections persist in 254 million and 58 million people worldwide, respectively. No approved therapy addresses these viruses simultaneously. MDL-001 is an oral, direct-acting, broad-spectrum antiviral targeting the Thumb-1 allosteric site of viral polymerases. Methods: Here, we evaluated the antiviral activity of MDL-001 in vitro in influenza A/B, RSV, SARS-CoV-2, endemic human coronaviruses, and hepatitis B/C/D. We next evaluated MDL-001 antiviral activity in vivo in H1N1, SARS-CoV-2, HCV, and HBV. MDL-001's in vivo efficacy was compared head-to-head versus standards of care including oseltamivir, remdesivir, sofosbuvir, and tenofovir alafenamide, or through the literature comparison with nirmatrelvir and molnupiravir. Lastly, we evaluated the pharmacokinetics, metabolism, tolerability, and safety profile of MDL-001. Results: Here, we report that MDL-001 inhibits influenza A/B, RSV, SARS-CoV-2, endemic human coronaviruses, and hepatitis B/C/D viruses with nanomolar EC90 potency in vitro. MDL-001 demonstrated equivalent in vivo efficacy to oseltamivir against mouse-lethal influenza A virus infection, reducing lung viral load by 2.6 log10 and preventing weight loss and mortality. MDL-001 demonstrated equivalent symptom reduction to subcutaneous remdesivir after SARS-CoV-2 infection. MDL-001 reduced SARS-CoV-2 lung viral titers by 2.9 log10, superior to the literature-reported 1.4 log10 and 1.0 log10 reductions for nirmatrelvir and molnupiravir, respectively. MDL-001 reduced HCV viremia by 3.3 log10, equivalent to sofosbuvir. Oral MDL-001 reduced plasma HBV surface antigen by 2.5 log10, superior to tenofovir alafenamide from Day 8 through Day 21. MDL-001 demonstrated an in vitro EC50 of 79.4 nM against infection with RSV strain A2, which is a 416-fold improvement over literature-reported ribavirin. Oral pharmacokinetics studies demonstrate that MDL-001 is rapidly absorbed and partitioned into lung (Kp = 39-52) and liver (Kp = 71-104) tissues. MDL-001 produced no treatment-related tolerability adverse events across 376 animals and showed no hERG, Ames genotoxicity, or micronucleus safety issues. Conclusions: These findings support MDL-001 as a broad-spectrum, direct-acting non-nucleoside antiviral clinical candidate.

PMID 42943336
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PubMedGastroenterology research and practice2026-10-27

Prevalence of Decisional Regret and Associated Risk Factors in Patients With Hepatitis B Undergoing Pegylated Interferon Alpha Therapy.

Lin Yufen Y, Xiong Huan H, Yi Shuanglian S, Xie Shanshan S

Pegylated interferon alpha has been shown to enhance the likelihood of achieving a functional cure in patients with hepatitis B. However, it was associated with a greater number of contraindications and adverse reactions compared with nucleotide analogs. Current research has placed comparatively less emphasis on the potential for this treatment to induce decision regret among patients. The aim of this study was to investigate the current status of decision regret in hepatitis B patients undergoing interferon therapy and to explore its influencing factors. A cross-sectional study was conducted in a comprehensive hospital in Xiamen, Fujian Province, China, from February 20 to June 13, 2024. The study recruited hepatitis B patients undergoing treatment with pegylated interferon alpha. The survey encompassed general information, the All Aspects of Health Literacy Scale, the Perceived Social Support Scale, the Control Preferences Scale, the Decisional Conflict Scale, and the Decision Regret Scale. A total of 130 questionnaires were analyzed. Only 13.85% of patients had no regrets at all about the decision, 34.60% experienced mild regret, and the proportion of patients with moderate to severe regrets reached 51.50%. Mild impact on life, active decision-making roles, passive decision-making roles, and decision conflict were the influencing factors of decisional regret in hepatitis B patients on pegylated interferon alpha therapy, which together explained 29.6% of the total variation. Hepatitis B patients undergoing pegylated interferon alpha therapy had a high percentage of decisional regret. Healthcare professionals should pay close attention to this phenomenon. In the future, they can investigate additional potential influencing factors and promptly develop intervention strategies to effectively reduce decision regret.

PMID 42936011
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PubMedBMC infectious diseases2026-10-27

Predicting hepatitis B incidence trends in China using Baidu Search Index and time series models: a comparative study of rolling forecasting and direct forecasting strategies.

Yang Xing X, Mai Huanzhuo H, Lan Liuyan L, Wei Wudi W et al.

Time series models are extensively used for predicting infectious disease incidence through direct time series forecasting, and the Baidu Search Index (BSI) has recently been employed as a reference for analyzing disease trends. However, for predicting the hepatitis B incidence in China, it is essential to explore the most suitable models and forecasting methods, as well as the effectiveness of using BSI. Data from the Chinese Center for Disease Control and Prevention, spanning January 2011 to December 2023, were used. Twelve models, including autoregressive integrated moving average (ARIMA), four deep learning models, and seven machine learning models were constructed to predict the reported incidence of hepatitis B in China. BSI-derived comprehensive search index (CSI) of hepatitis B-related keywords was employed as an exogenous variable for model construction. Both direct time-series forecasting and rolling forecasting were applied to predict the time series data in each model. Models' predictive accuracy was evaluated using mean absolute percentage error (MAPE), weighted mean absolute percentage error (WMAPE), mean absolute error (MAE), mean square error (MSE), and root mean square error (RMSE), each accompanied by its 95% confidence interval (CI). Statistical significance was assessed using one-sided Diebold-Mariano tests. The ARIMA(0,1,1)(0,1,1)12 model (WMAPE = 0.0821, 95% CI 0.0512-0.1312) outperformed other models in predicting hepatitis B reported incidence. In the primary split with single-step rolling forecasting, incorporating the CSI improved point-estimate predictive performance for nearly all models forecasting hepatitis B reported incidence, particularly in ARIMAX(1,1,1)(0,1,2)12 (WMAPE 0.0548 vs. 0.0821), CNN (WMAPE 0.0845 vs. 0.1105), LSTM (WMAPE 0.0947 vs. 0.1067), Decision Tree (WMAPE 0.0972 vs. 0.1178), Random Forest (WMAPE 0.0956 vs. 0.1044), AdaBoost (WMAPE 0.0973 vs. 0.1049), and XGBoost (WMAPE 0.0996 vs.0.1039) models. Among these, statistically significant improvements were observed for ARIMA, CNN, and Decision Tree (P < 0.05). This study provides evidence that ARIMA model demonstrates excellent predictive performance for forecasting hepatitis B incidence trends in China. Additionally, BSI could serve as an effective supplement to traditional surveillance systems by providing real-time contemporaneous information that enhances situational awareness. Furthermore, adopting rolling forecasting might improve predictive accuracy for certain models and in specific contexts.

PMID 42934538
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PubMediScience2026-10-27

Metabolic network restoration, not donor microbial engraftment, associates with resolution of recurrent Clostridioides difficile infection.

Whitman Brendan T BT, Karimianghadim Ramin R, Auch Benjamin B, Liachko Ivan I et al.

Fecal microbiota transplantation (FMT) effectively prevents recurrent Clostridioides difficile infection (rCDI). However, the mechanisms underpinning FMT efficacy are incompletely understood. We used proximity-ligation metagenomics, metaproteomics, and metabolomics to profile dynamic changes in rCDI. We analyzed samples collected from the first 7 responders during a clinical trial comparing two donor-based treatments (lyophilized FMT [LFMT] or lyophilized sterile fecal filtrate [LSFF], free of intact microorganisms) to prevent rCDI. LSFF is enriched in Caudoviricetes, lipids, fatty acids, and human and extracellular bacterial proteins compared with LFMT. LFMT recipients had donor microbial engraftment, while LSFF recipients achieved only partial microbial community recovery without donor's contribution. Our multi-omics analyses identified a functional convergence following both treatments, shifting away from oxidative and antibiotic stress survival pathways toward enhanced carbon-nitrogen utilization pathways, suggesting that FMT mechanisms may involve metabolic reprogramming and host-microbial amino acid co-metabolism. Our findings provide important hypothesis-generating insights that warrant further validation.

PMID 42935761
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