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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

PubMedJournal of the International AIDS Society2026-10-26

Impact of HIV Pre-Exposure Prophylaxis on HIV Incidence and Hepatitis B Outcomes Among Sex Workers Living With Hepatitis B: A Modelling Analysis in Côte D'Ivoire.

Mohareb Amir M AM, Kim Arthur Y AY, Kouamé Menan Gérard MG, Nouaman Marcellin M et al.

Nearly 10% of sex workers in sub-Saharan Africa live with chronic hepatitis B virus (HBV). HIV pre-exposure prophylaxis (PrEP) using tenofovir/emtricitabine (TDF/FTC) has not been studied in this population, possibly due to concerns of hepatitis flares following TDF/FTC cessation. Using a microsimulation model of HIV and HBV disease and data from 2016 to 2024, we compared the clinical impact of TDF/FTC as PrEP versus no TDF/FTC among women who sell sex with HBV in Côte d'Ivoire. We incorporated the anti-HBV effects of TDF/FTC and the increased probability of hepatitis flares and HBV surface antigen (HBsAg) loss following TDF/FTC cessation. We estimated input parameters from published literature: HIV incidence (1.9-3.0 per 100 person-years), PrEP adherence (55%), disengagement from PrEP care (4% per month for the first 12 months, then 12.5% per month), hepatitis flare incidence (2.0-4.0 per 100 person-years) and rate of HBsAg loss (1.0 per 100 person-years), which both increase following TDF/FTC cessation. Model outcomes included cumulative HIV incidence, average hepatitis flares, HBsAg loss and survival over 2, 5 and 10 years. We conducted sensitivity analyses varying HIV incidence, PrEP adherence, disengagement from PrEP care and hepatitis flare rate. Compared with no TDF/FTC, TDF/FTC would reduce cumulative HIV incidence: 4.1% versus 5.6% at 2 years and 10.1% versus 12.7% at 5 years. TDF/FTC would result in more hepatitis flares (mean 0.76 vs. 0.19 per person) and more HBsAg loss (8.4% vs. 5.7%) than no TDF/FTC after 5 years. Two- and five-year survival would be similar between the two strategies, and TDF/FTC would improve survival over longer horizons. Improving adherence and reducing disengagement from care would increase clinical benefits. Even with high disengagement from care and high risk of hepatitis flares, TDF/FTC would reduce HIV acquisition and improve overall long-term survival. Women who sell sex with HBV in Côte d'Ivoire would benefit from TDF/FTC as PrEP to avoid HIV acquisition. The increased risk of hepatitis flares, while challenging to manage in resource-limited settings, would be outweighed by the benefits of HIV prevention. Efforts should be made to scale up PrEP in sex workers, including women with chronic HBV.

PMID 42929139
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PubMedEuropean journal of pediatrics2026-10-26

Systematic STI screening in unaccompanied migrant minors: a 6-year experience with urine-based NAAT.

Milkova-Ivanova Sonia S, Mellado-Sola Isabel I, Bravo-Queipo-de-Llano Blanca B, Rodríguez-Molino Paula P et al.

Systematic screening for sexually transmitted infections (STI), beyond serology, is not standard in arrival protocols for unaccompanied migrant minors (UMM). In 2020, our center incorporated urine-based nucleic acid amplification tests (NAAT)-based screening into the existing serology-based protocol (HIV, syphilis, hepatitis B/C), and we describe the additional diagnoses of STI identified through NAAT. We conducted a retrospective observational descriptive study (2020-2025) of 226 UMM (99.6% male) in Madrid undergoing serological screening for HIV, syphilis, hepatitis B and C, with additional urine-based multiplex PCR (NAAT) screening for STI. Urine-based NAAT, performed in 163/226 participants (72.1%), identified six positive cases (3.7%, 95% CI 1.4-7.8%) of C. trachomatis, M. genitalium, or Ureaplasma spp. Of these, four patients (2.5%, 95% CI 0.7-6.2%) had actionable infections that were treated. Serology identified no HIV (0/218) or hepatitis C cases (0/212), one syphilis case (0.5%, 95% CI 0.0-2.6%, 1/209), and three chronic hepatitis B cases (1.4%, 95% CI 0.3-3.9%, 3/221). None of the cases had symptoms recorded. Urine NAAT identified six infections (four actionable) not detectable by serology. However, three of eight patients with actionable infections were lost to follow-up, highlighting that the benefit of systematic screening depends on strengthening linkage-to-care alongside testing. • Serological screening (HIV, syphilis, hepatitis B/C) is standard in arrival health assessments for unaccompanied migrant minors, but systematic STI screening beyond serology is not routinely protocoled. • Systematic screening is especially valuable in this population, as follow-up is often limited by care fragmentation and transfers between reception centers. • Urine-based NAAT screening identified additional STI in patients with no symptoms recorded, that were not detectable by serology alone.

PMID 42928391
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PubMedDiseases (Basel, Switzerland)2026-10-26

Cognitive-Affective Dimension After Virological Cure of Hepatitis C Virus Infection: WBSI Dynamics, Liver Status, and the Role of Comorbidities.

Baltă Alexia Anastasia Ștefania AAȘ, Lescai Alina-Maria AM, Stoian Valerian Ionut VI, Ignat Mariana Daniela MD et al.

Virological cure in chronic infection with hepatitis C virus (HCV) is followed by important clinical and biological benefits, including psychological ones. The White Bear Suppression Inventory (WBSI) assesses the tendency to suppress intrusive thoughts and was used in this study as a tool to provide a cognitive-affective assessment of patients with chronic HCV infection-both at the start of antiviral therapy and five years after achieving virological cure. This study aimed to characterize patients with HCV infection who received antiviral therapy and completed the WBSI, to assess longitudinal changes in WBSI scores, and to identify clinical, biological, and comorbidity-related factors associated with these changes. The study employed an ambispective observational longitudinal cohort study design conducted on a sample of 386 patients, of whom 81 completed the WBSI both at baseline and at follow-up. The WBSI subsample did not differ significantly from the remainder of the cohort in terms of age, cytolysis markers, bilirubin, albumin, platelet count, or major comorbidities. The WBSI score decreased significantly from baseline to follow-up, from 61.36 to 54.16, with a mean difference of 7.20 points (t = 6.32; p < 0.001). The correlation between the baseline and follow-up scores was very strong (r = 0.899; p < 0.001), indicating substantial interindividual stability. ΔWBSI was weakly but significantly correlated with the change in total bilirubin (r = 0.254; p = 0.022), with no significant correlations with the other biological markers. In the multivariable model, cardiovascular comorbidities (B = -8.469; p < 0.001) and metabolic comorbidities (B = -9.869; p = 0.002) were independent negative predictors of WBSI scoring, whereas fibrosis evolution, age, sex, and baseline total bilirubin had no significant influence. Improvements in WBSI scores observed only in specific patient subgroups, one year after achieving HCV virological cure, underscore the need to integrate psychological assessment into long-term monitoring, particularly for patients with cardiovascular and metabolic comorbidities.

PMID 42930013
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PubMedGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2026-10-26

Outcomes of subthreshold diode micropulse laser and anti-VEGF vs anti-VEGF monotherapy for diabetic macular edema: a meta-analysis.

Sothivannan Amirthan A, Leung Victoria V, Pandya Bhadra U BU, Long Clara C et al.

To compare visual and anatomic outcomes in patients with diabetic macular edema treated with subthreshold diode micropulse laser photocoagulation (SDMLP) and anti-VEGF combination therapy versus anti-VEGF injection monotherapy. Meta-analysis. We searched MEDLINE, EMBASE, and Cochrane Library between January 2005 and April 2025 for randomized controlled trials (RCTs) and observational studies comparing best-corrected visual acuity (BCVA) and central macular thickness (CMT) after SDMLP and anti-VEGF combination therapy versus anti-VEGF monotherapy. The primary outcome was change in BCVA (∆BCVA). Secondary outcomes included absolute BCVA and CMT at all time points, change in CMT (∆CMT) from baseline to all time points, and the number of anti-VEGF injections over 12 months. Outcomes were reported as a weighted mean difference (MD) with 95% confidence intervals (CI). Nine studies (5 RCTs, 4 cohort studies) comprising 535 eyes from 500 patients were included. The mean baseline BCVA was 0.56 ± 0.32 logMAR (Snellen equivalent: 20/72) and 0.56 ± 0.33 logMAR (Snellen equivalent: 20/72) in the combination and monotherapy groups, respectively. The mean baseline CMT was 431.87 ± 83.68 µm in the combination group and 411.87 ± 73.47 µm in the monotherapy group. ∆BCVA at 12 months marginally favoured combination therapy (MD [95% CI]: -0.043 [-0.086, -0.0001] logMAR (~2 Snellen letters), p=0.0497), although this difference was not statistically significant when the analysis was restricted to RCTs (-0.054 [-0.109, 0.0012] logMAR, p=0.055). Among secondary outcomes, combination therapy was superior for absolute BCVA at 12 months (MD [95% CI]: -0.062 [-0.10, -0.022] logMAR (~3 Snellen letters), p<0.001) and CMT at 12 months (MD [95% CI]: -15.3 [-20.9, -9.8] µm, p<0.001), with no significant difference in ∆CMT at 12 months (MD [95% CI]: -11.3 [-29.0, 6.4] µm, p>0.05) and significantly fewer anti-VEGF injections at 12 months (MD [95% CI]: -2.1 [-3.0, -1.1], p<0.001). GRADE analysis identified a low certainty of evidence for the primary outcome. In patients with DME, SDMLP and anti-VEGF combination therapy appears comparable, and possibly modestly superior to anti-VEGF monotherapy, with a reduced injection burden over 12 months. BCVA and CMT differences were below clinically important thresholds and supported by low-certainty evidence.

PMID 42928376
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PubMedNanoscale horizons2026-10-26

Elimination of tumors and their metastasis by a thermally responsive silica nanoparticle decorated with an anti-PD-L1 antibody fragment.

Park Hae-Bin HB, Hwang Juyoung J, Kim Hee-Sung HS, Kim So-Jung SJ et al.

Metastasis and recurrence remain the leading causes of cancer-related mortality; however, existing therapies offer limited protection against systemic tumor spread following primary treatment. Here, we report a dual-function nanoplatform, anti-programmed cell death protein-ligand 1 PD-L1 antigen-binding fragment (Fab)-conjugated thermally responsive silica (α-TRS) nanoparticles, rationally designed to achieve complete ablation of primary tumors through photothermal therapy (PTT) while simultaneously priming systemic antitumor immunity to suppress distant metastasis. Indocyanine green (ICG) was encapsulated within mesoporous silica nanoparticles with high efficiency (91.2%), and the Fab of an anti-PD-L1 antibody was site-specifically conjugated to the nanoparticle surface via NTA-Ni2+/His-tag chemistry. With 808 nm near-infrared (NIR) laser irradiation, α-TRS generated sufficient heat (∼50 °C) to induce ablative tumor cell death in vitro and achieved complete remission of 4T1 breast tumors and CT-26 colon tumors in vivo following intratumoral injection. Critically, mice cured of primary tumors by α-TRS-mediated PTT were fully protected against subsequent intravenous rechallenge with lung-metastatic 4T1 and CT-26 cells, whereas mice treated with PTT alone (TRS without Fab) showed only partial protection. This abscopal-like protection was mechanistically linked to the robust activation of tumor antigen-specific CD4+ and CD8+ T cells, including enhanced production of interferon (IFN)-γ, tumor necrosis factor (TNF)-α, perforin, and granzyme B in response to tumor antigens. These findings suggest that ablative PTT combined with local PD-L1 checkpoint blockade can convert a localized thermal intervention into durable systemic immunity, offering a promising proof-of-concept strategy for simultaneously treating primary tumors and preventing metastatic recurrence.

PMID 42929782
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PubMedAdvanced biology2026-10-26

Targeting Fibrotic Scars With Extracellular Vesicles Extracted From Mature Aloe vera Gel: Enhanced Antioxidant, Anti-Inflammatory, and Antifibrotic Activity Through M2 Macrophage Polarization and Inhibition of Myofibroblast Differentiation.

Ceballos-Santa M Camila MC, Venkatachala-Babu Janitri J, Gaborski Thomas R TR, Schulze Stefan S et al.

Abnormal scarring and fibrotic skin disorders arise from dysregulated wound healing. While Aloe vera is widely recognized for its therapeutic properties, the potential of its extracellular vesicles (Av-EVs) remains underexplored. To isolate and characterize Av-EVs and evaluate their antioxidant, anti-inflammatory, and antifibrotic properties in vitro, focusing on extraction method and plant maturity. Av-EVs were isolated from the gel of mature and young Aloe vera leaves using manual (NB) or blender-based (B) homogenization and characterized by nanoparticle tracking analysis, transmission electron microscopy, protein quantification, and immunoblotting of EV-associated markers. Antioxidant and cytotoxicity assays (DPPH, alamarBlue) were followed by functional anti-inflammatory and antifibrotic analyses in LPS-stimulated THP-1 macrophages and TGF-β1/vitamin C-activated human dermal fibroblasts (RT-qPCR, immunofluorescence). Proteomic analysis was performed to investigate maturity-dependent differences in Av-EV cargo. Mature NB-derived EVs exhibited the strongest bioactivity, with superior antioxidant capacity, suppression of pro-inflammatory mediators, enhanced M2 macrophage polarization, and significant downregulation of COL1A1 and α-SMA. Immunoblotting further supported Av-EV identity and sample purity. B-derived and young EVs showed reduced bioactivity, with the latter failing to inhibit fibrotic markers. Manually extracted Av-EVs from mature leaves demonstrate superior multifunctional bioactivity, supporting their potential as plant-derived nanotherapeutics for fibrotic scar modulation.

PMID 42929735
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