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anti-hepatitis-B therapy (IMMUNO HBS / UMANBIG / IMMUNOHBS)

✓ Approved

Kedrion · 多克隆抗体 · 多克隆抗体

什么是 anti-hepatitis-B therapy？

anti-hepatitis-B therapy 是一种多克隆抗体，由Kedrion研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Intravenous (IV)。

药物档案

商品名IMMUNO HBS, UMANBIG, IMMUNOHBS
公司Kedrion
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intramuscular (IM) Injection, Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Kedrion

治疗适应症

anti-hepatitis-B therapy 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

PubMedVaccines2026-07-27

Hepatitis B Vaccination in People Living with HIV: Bridging the Immunological Gap.

Radi Christelle C, Abu Faraj Jana J, Idriss Jad J, Gromer Daniel J DJ et al.

Hepatitis B virus (HBV) infection remains a major driver of liver-related morbidity and mortality among people living with HIV (PLWH), yet vaccine-induced protection is frequently suboptimal. HIV-associated immune dysfunction, including CD4+ T-cell depletion, altered antigen presentation, impaired T follicular helper cell support, and B-cell dysregulation, reduces seroprotection after standard recombinant HBV vaccines and may limit durability of antibody responses. Vaccine response is further influenced by HIV viral suppression, age, comorbidities, prior vaccine history, and baseline HBV serologic status, including isolated hepatitis B core antibody (anti-HBc) and occult HBV infection (OBI) considerations. Although antiretroviral therapy (ART) improves vaccine responsiveness, many PLWH fail to achieve protective hepatitis B surface antibody (anti-HBs) titers (≥10 mIU/mL) after conventional schedules, or experience antibody waning over time. Current guidelines recommend HBV vaccination for all susceptible PLWH with post-vaccination serologic testing and revaccination for nonresponders. Persistent implementation barriers, including incomplete series, vaccine hesitancy, stigma, and logistical constraints, continue to limit real-world impact. Emerging clinical trial data support CpG-adjuvanted HBV vaccines (HepB-CpG/Heplisav-B) and intensified dosing and schedules (double-dose or four-dose regimens) to improve seroprotection and generate higher peak anti-HBs titers, which may enhance durability. This review synthesizes guideline recommendations, immunologic mechanisms of hyporesponsiveness, predictors of vaccine response, and practical strategies to optimize HBV vaccination in PLWH.

PMID 42506660
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PubMedZhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology2026-07-27

[Clinical significance and occurrence mechanism of hepatitis B virus DNA integration].

Shi Y J YJ, Zhang K X KX, Li M Y MY, Lu D J DJ et al.

Double-stranded linear DNA (dslDNA), considered to serve as a major precursor to integrated HBV DNA (iDNA), is generally located in the livers of patients with chronic HBV infection. Prior research has primarily focused on the role and mechanisms of HBV integration in the progression of hepatocellular carcinoma (HCC), demonstrating that iDNA can lead to genomic instability in the host and induce aberrant expression of host tumor-related genes around the integration sites, while viral proteins expressed by iDNA exhibit tumor-promoting effects. In recent years, the impact of iDNA-derived hepatitis B surface antigen on antiviral therapy in patients with chronic hepatitis B has received increasing attention with a deeper understanding of integrated HBV DNA. Consequently, the field has become a research hotspot and challenge in determining how to eliminate or silence iDNA to improve functional cure in patients with chronic hepatitis B. This paper aims to provide new sights to the clinical significance of iDNA and a theoretical basis for optimizing antiviral therapy strategies by summarizing the occurrence mechanisms of iDNA and its impact on the onset and progression of hepatocellular carcinoma and antiviral therapy for patients with chronic hepatitis B.

PMID 42503913
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PubMedZhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology2026-07-27

[APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update].

You H H, Maiwall Rakhi R, Chen J J, Ahn H O O N HOON et al.

Globally, especially in the Asia-Pacific region, chronic hepatitis B infection has led to an undesirable escalating morbidity and mortality with acute-on chronic liver failure, end-staged liver cirrhosis and hepatocellular carcinoma. This has happened despite the past four-decades of major scientific advances made in screening methods, vaccination strategies, highly effective low-cost anti-viral therapies and surveillance strategies for early detection of hepatocellular carcinoma. To address this health threat, APASL has formed a Viral Elimination Taskforce to unite key opinion leaders from its member countries and regions. The ongoing shifts in hepatitis B epidemiology, socioeconomic changes, and advancements in technology are taken into consideration. With the conjoint efforts of all the members of the APASL Viral Elimination Taskforce, these clinical practice guidelines have been formulated aiming to facilitate healthcare professionals, policy makers and patients in making practical and cost-effective management decisions for chronic hepatitis B infection. Altogether, it provides recommendations in thirteen major areas related to screening, vaccination, treatment and HCC surveillance. The implementation of these clinical practice guidelines represents major APASL effort toward elimination of the disease burden due to chronic hepatitis B infection in Asia-Pacific region.

PMID 42503908
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PubMedThe Analyst2026-07-27

A highly sensitive and specific fluorescent immunoassay for hepatitis B envelope antigen detection using AIE-encoded nanobioprobes.

Shi Yixin Y, Lu Xinxi X, Li Yifang Y, Cao Youlang Y et al.

Developing highly sensitive, efficient, stable, and low-cost viral antigen detection strategies suitable for primary healthcare settings is of great significance for the early diagnosis and treatment of viral infections. Herein, we report a highly efficient fluorescent immunoassay strategy for the detection of hepatitis B envelope antigen (HBeAg) based on aggregation-induced emission (AIE) molecule-encoded fluorescent nanospheres. Three AIE luminogens (TPE-Br4, TPE-O2, and TPE-O3) were encapsulated into carboxyl-functionalized nanospheres via an ultrasonic swelling method, yielding uniform and well-dispersed multicolor fluorescent nanospheres. Among them, the red-emitting nanospheres, exhibiting superior photostability, were selected as signal output units. Anti-hepatitis B envelope antibodies were subsequently conjugated onto their surfaces to construct fluorescent nanobioprobes. By integrating these nanobioprobes with a sandwich-type enzyme-linked immunosorbent assay, specific capture and recognition of HBeAg were successfully achieved. The proposed method demonstrated a linear detection range of 0.01-1 ng mL-1 and an ultra-low limit of detection (LOD) of 9 pg mL-1. In addition, it exhibited excellent specificity and robust anti-interference performance in spiked fresh mouse serum samples. Overall, this work presents a sensitive, convenient, and cost-effective sensing platform for HBeAg detection, showing great potential for rapid and on-site screening of viral antigens in clinical applications.

PMID 42504878
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PubMedVaccines2026-07-27

Evaluation of Hepatitis B Vaccine Immunogenicity in Low-Birth-Weight Infants After Complete Immunization: The Impact of Postnatal Catch-Up Growth and Maternal-Neonatal Characteristics.

Shen Lu L, Tang Wanqin W, Xie Yan Y, Hu Ran R et al.

Background: Low-birth-weight (LBW, <2500 g) infants are at increased risk of suboptimal hepatitis B vaccine responses; yet, data on their immunogenicity patterns and modifiable determinants remain limited. This study aimed to assess hepatitis B vaccine immunogenicity in LBW infants and to examine whether postnatal catch-up growth and maternal-neonatal characteristics are independently associated with antibody levels. Methods: We enrolled 511 LBW infants who completed the recommended 3-dose hepatitis B vaccination series at 0, 1, and 6 months. Blood samples were collected 4-6 weeks after completion of the full vaccination series. Geometric mean concentration (GMC) and seroprotection rate (SPR, anti-HBs ≥ 10 mIU/mL) were evaluated. Catch-up growth was quantified as the change in weight-for-age Z-score between 6 and 8 months of age (ΔWAZ). Multivariable linear regression was used to identify independent predictors of log-transformed antibody titers, adjusting for gestational age, maternal hepatitis B surface antigen (HBsAg) positivity, maternal body mass index (BMI), maternal fasting glucose, maternal thyroid disease, infant hemoglobin at 6 months, and ΔWAZ. Results: The overall SPR was 99.41% (508/511), with a GMC of 1045.37 mIU/mL (95% CI: 916.24-1192.70). SPR remained consistently high across all subgroups. In multivariable analysis, ΔWAZ was not significantly associated with antibody levels (β = -0.063, p = 0.571). Maternal HBsAg positivity showed no significant association (β = -0.104, p = 0.792). Maternal thyroid disease was independently associated with higher antibody levels (β = 0.793, 95% CI: 0.213-1.373, p = 0.007). None of the other covariates reached statistical significance. Conclusions: Hepatitis B vaccination demonstrated high immunogenicity in LBW infants, with very high seroprotection rates. Postnatal catch-up growth did not independently influence antibody levels. The significant positive association between maternal thyroid disease and infant antibody response warrants further prospective investigation.

PMID 42506603
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PubMedDiseases (Basel, Switzerland)2026-07-27

Impact of Gene Polymorphism rs2275913 and Serum IL-17A Levels on Liver Fibrosis Severity Across the Natural History of Chronic Hepatitis B in Indonesia.

Maimunah Ummi U, Palayukan Andrio A, Juniastuti, Tjokroprawiro Brahmana Askandar BA et al.

A complex interplay between viral activity and host immune responses drives the progression of liver fibrosis in chronic hepatitis B. The T helper 17 (Th17) immune pathway, which produces the pro-inflammatory cytokine interleukin-17A (IL-17A), has been implicated in hepatic fibrogenesis. However, the relationship between IL-17A levels, IL-17A G197A (rs2275913) gene SNP, and the degree of liver fibrosis across different phases of the natural history of chronic hepatitis B remains insufficiently explored. This study employed an analytical observational design with a cross-sectional approach in treatment-naïve patients with chronic hepatitis B. The degree of liver fibrosis was assessed using liver elastography. IL-17A (rs2275913) gene SNP was analysed using Real-Time PCR, while serum IL-17A levels were measured using enzyme-linked immunosorbent assay. Statistical analyses included Spearman's correlation, the contingency coefficient, the Chi-square test, the Kruskal-Wallis test, and the Mann-Whitney test, with a significance level set at p < 0.05. A total of 76 patients with chronic hepatitis B were included in this study. The phase of disease progression was significantly associated with the degree of liver fibrosis (p = 0.016). Median IL-17A levels increased in parallel with fibrosis severity (p = 0.003), with a particularly significant association observed during the R phase (p = 0.002). However, no significant association was found between the IL-17A G197A (rs2275913) gene SNP and either liver fibrosis severity or serum IL-17A levels. Elevated serum IL-17A levels were associated with greater liver fibrosis severity, particularly during the reactivation phase of chronic hepatitis B. These findings suggest a potential relationship between IL-17A-mediated immune responses and liver fibrosis in patients with chronic hepatitis B.

PMID 42505555
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