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

✓ Approved

Kedrion · Polyclonal Antibodies · Polyclonal Antibodies

What is anti-hepatitis-B therapy?

anti-hepatitis-B therapy is a polyclonal antibodies developed by Kedrion. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or intravenous (iv).

Drug Profile

Brand NamesIMMUNO HBS, UMANBIG, IMMUNOHBS
CompanyKedrion
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intramuscular (IM) Injection, Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Kedrion

Therapeutic Indications

anti-hepatitis-B therapy is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedBiomedical and environmental sciences : BES2026-11-12

HBcrAg Predicts Post-IFN-α Therapy Relapse in CHB.

Yao Lin Mei LM, Mao Chuan Chun CC, Tian Yuan Y, Lu Yao Y et al.

Serum markers predicting virologic relapse after pegylated interferon-alpha (Peg-IFN-α) discontinuation in patients with chronic hepatitis B (CHB) are lacking. This study aimed to evaluate serum pregenomic RNA (pgRNA), hepatitis B core-related antigen (HBcrAg), and hepatitis B surface antigen (HBsAg) as potential predictors of Peg-IFN-α treatment outcomes and post-treatment virologic relapse in treatment-naïve patients with CHB. A total of 371 treatment-naïve patients with CHB were initially recruited for this study, and 327 patients who completed the entire follow-up period were included in the data analysis. Serum pgRNA and HBcrAg levels were measured by polymerase chain reaction (PCR)-fluorescence probing and enzyme-linked immunosorbent assay (ELISA), respectively. Among the 327 followed patients, 112 (34.25%) achieved a virologic response to Peg-IFN-α; 16 (14.29%) experienced virologic relapse over a median follow-up of 12 months. Baseline pgRNA (odds ratio [ OR], 0.571), HBcrAg ( OR, 0.539), and HBsAg ( OR, 0.356) levels correlated with treatment efficacy, demonstrating predictive values with AUCs of 0.821, 0.879, and 0.781, respectively. HBcrAg levels at treatment discontinuation were associated with virologic relapse and showed potential as predictive biomarkers (AUC, 0.790). Serum pgRNA, HBcrAg, and HBsAg correlate with Peg-IFN-α response in treatment-naïve CHB. Serum HBcrAg levels at Peg-IFN-α discontinuation show potential as a predictive biomarker for post-treatment virologic relapse and are associated with relapse risk, which may help identify high-risk patients after Peg-IFN-α cessation. Notably, this finding requires further validation in larger cohorts due to the limited number of relapse events.

PMID 43016187
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PubMedJournal of the European Academy of Dermatology and Venereology : JEADV2026-11-12

Real-world effects of beremagene geperpavec in epidermolysis bullosa.

Karakioulaki Meropi M, Frank Robin R, Storz Oliver O, Yang Hanning H et al.

Dystrophic epidermolysis bullosa (DEB) is a severe inherited skin fragility disorder caused by mutations in COL7A1, leading to wounds, inflammation and impaired quality of life. Beremagene geperpavec (B-VEC) is the first approved topical gene therapy delivering functional COL7A1 via a modified HSV-1 vector, enabling local collagen VII expression and improved wound healing. To evaluate the real-world, multidimensional long-term outcomes of B-VEC treatment in patients with DEB, including wound healing, systemic inflammation, (auto)-antibody profiles and patient-reported outcomes. In this multicentre observational study, 38 patients with DEB received B-VEC treatment between January 2024 and June 2026. The primary endpoint was the change in wound surface area from baseline during B-VEC treatment. Secondary endpoints included changes in systemic inflammatory and haematological parameters [C-reactive protein (CRP), interleukin-6 (IL-6), serum amyloid A (SAA), leucocytes and haemoglobin (Hb)], (auto-)antibody profiles [anti-C7, BP180, BP230 and herpes simplex virus (HSV)-1/2 IgG], body mass index (BMI) and patient-reported outcomes, including pain, pruritus, treatment satisfaction and wound dressing time. B-VEC treatment was associated with a significant reduction in wound surface area across healing wounds. Patients having persistent wounds exhibited lower BMI and higher leucocyte counts and received systemic biologic therapies less frequently. Anti-BP180, BP230 and HSV-1/2 titres remained stable, while anti-C7 levels increased during treatment. IIF was negative in most patients and did not differ between groups. Systemic inflammation showed a mixed pattern, with reduced leucocyte counts and SAA levels, and slightly increased CRP and IL-6 under treatment. Hb and BMI increased during treatment. Most patients reported high treatment satisfaction and reduction in pain, pruritus and wound dressing time. B-VEC therapy provides clinically meaningful improvements in wound healing, patient-reported outcomes and selected systemic parameters in DEB. Treatment response is influenced by host factors such as BMI, systemic inflammation and concomitant therapies. Baseline (auto)-antibody profiles do not appear to predict treatment efficacy. Overall, B-VEC represents a significant advancement in the multidimensional management of DEB in real-world clinical practice.

PMID 43018251
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PubMedThe American journal of gastroenterology2026-11-12

Comparative Risk of Cancer with non-TNF Advanced Therapies Versus Anti-TNF Therapy in Inflammatory Bowel Disease.

Ibrahim Maryam K MK, Wanchaitanawong Wasuwit W, Tripathi Isita I, Anvari Sama S et al.

Safety is important when selecting advanced therapies for inflammatory bowel disease (IBD). Safety data for anti-interleukin therapy (anti-IL) or vedolizumab come from trials with limited follow-up, and direct comparisons with anti-tumor necrosis factors (anti-TNFs) for incident cancer are lacking. We evaluated cancer incidence in patients with IBD treated with anti-IL therapy or vedolizumab versus anti-TNFs. We conducted a retrospective cohort study of adults with IBD and no prior cancer who initiated anti-IL therapy, vedolizumab or anti-TNFs. Our primary outcome was incident cancer from 90 days after therapy initiation through discontinuation. We calculated incidence rates and performed Cox proportional hazards models. We identified 4,019 advanced therapy starts: 995 anti-IL, 692 vedolizumab, and 2,332 anti-TNF starts, with mean therapy duration of 1096 days. In multivariable analysis, there was a trend towards a lower hazard of all cancers among anti-IL users compared to anti-TNF users (HR 0.47; 95% CI 0.21-1.04), which was significant on sensitivity analyses. There was no difference in hazard of skin cancers (HR 1.56; 95% CI 0.39-6.15); however, the hazard of non-skin cancer was significantly lower among anti-IL users compared to anti-TNF users (HR 0.28; 95% CI 0.09-0.81). When comparing vedolizumab to anti-TNFs, there was no significant difference in the hazard of all cancer (HR 0.52, 95% CI 0.24-1.12) and non-skin cancer (HR 0.63, 95% CI 0.29-1.39). We found no evidence of an increased cancer risk with anti-IL therapy compared with anti-TNF therapy in patients with IBD. There was no difference in the cancer risk between vedolizumab and anti-TNF therapy.

PMID 43016241
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PubMedBMC infectious diseases2026-11-12

Prevalence of hepatitis E virus in pregnant women in Northeast Brazil.

Melo José Humberto de Lima JHL, Júnior José Valter Joaquim Silva JVJS, Cunha Gabriel Galindo GG, Paz Maria Gabriela Oliveira da MGOD et al.

Hepatitis E virus (HEV) infection remains underrecognized in many low- and middle-income settings, particularly among pregnant women, a population potentially vulnerable to adverse maternal and fetal outcomes. We investigated HEV seroprevalence, molecular detection, and epidemiological characteristics among pregnant women attending antenatal care services in northeastern Brazil. Serum samples from 900 pregnant women were screened for anti-HEV IgG. Reactive samples were further tested for anti-HEV IgM using two commercial immunoassays and for HEV RNA by real-time reverse transcription polymerase chain reaction (RT-qPCR). Demographic, environmental, and obstetric variables were analyzed using appropriate statistical tests. Anti-HEV IgG was detected in two pregnant women (0.22%; 2/900), whereas no samples were positive for anti-HEV IgM. Both IgG-positive women tested positive for HEV RNA by RT-qPCR, were asymptomatic at the time of sampling, and reported exposure profiles compatible with recognized fecal-oral transmission routes. No statistically significant associations were observed between HEV positivity and the variables evaluated. This study reports the seroprevalence and molecular detection of HEV among pregnant women attending antenatal care services in northeastern Brazil. Beyond providing epidemiological data, these findings highlight the importance of combining serological and molecular approaches for HEV investigation and reinforce the need for further epidemiological studies to better define the public health relevance of HEV infection during pregnancy. Not applicable.

PMID 43015640
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PubMedCellular and molecular life sciences : CMLS2026-11-12

GBP2 counteracts interferon therapy by stabilizing HBx to promote HBV replication and progression.

Wang Fei F, Song Hongxiao H, Xu Fengchao F, Li Xiaolu X et al.

Type I interferon (IFN-I) is widely used for the treatment of hepatitis B virus (HBV) infection, yet its therapeutic efficacy remains limited. Here, we identify guanylate-binding protein 2 (GBP2), an interferon-stimulated gene, as a host factor that paradoxically promotes HBV replication. GBP2 overexpression stabilized the viral regulatory protein HBx and markedly prolonged its half-life, whereas GBP2 knockdown facilitated HBx degradation. Mechanistically, GBP2 recruited the E3 ligase HUWE1 to induce K29-linked ubiquitination of HBx at lysine 95, which in turn suppressed K48-linked ubiquitination and proteasomal degradation. Functionally, GBP2-mediated HBx stabilization enhanced HBV replication and promoted hepatoma cell migration and invasion. Importantly, GBP2 expression was elevated in PBMCs of HBV-infected patients and further induced by IFN-I treatment, while HBV delayed early IFN-mediated GBP2 induction in HBV-containing hepatocyte-derived cells. Together, these findings reveal a novel mechanism by which GBP2 antagonizes the antiviral activity of IFN-I by stabilizing HBx, thereby facilitating HBV replication and potentially contributing to hepatocarcinogenesis. In brief, IFN activates ISGF3 via the JAK-STAT signaling pathway to produce the IFN-stimulating gene, GBP2, which promotes the K29 chain ubiquitination of HBx protein on the K95 site, which in turn competitively inhibits the K48 chain ubiquitination of HBx, thereby inhibiting HBx protein degradation.

PMID 43015458
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PubMedFrontiers in immunology2026-11-12

Successful treatment of anti-glomerular basement membrane antibody disease combined with membranous nephropathy using rituximab: a case report.

Cheng Yaqian Y, Shao Guojian G, Shao LingJiu L, Xie ZhouTao Z et al.

Anti‑glomerular basement membrane (anti‑GBM) disease is a rare autoimmune disorder that classically manifests as rapidly progressive glomerulonephritis and pulmonary hemorrhage. The coexistence of anti-GBM disease and membranous nephropathy (MN) was first reported in 1976. Although such cases are rare, many reported patients develop progressive kidney injury and poor renal outcomes. We report a young man with sequential-onset dual glomerulopathy. He initially presented with MN alone and achieved partial remission following glucocorticoid and cyclosporine therapy. Three years later, he developed rapidly progressive glomerulonephritis, and kidney biopsy confirmed anti-GBM disease superimposed on pre-existing MN. This sequential pattern differs from the simultaneous onset of both lesions reported in many previous cases. To minimize gonadal toxicity, he received individualized therapy consisting of glucocorticoids, dose-adjusted cyclophosphamide, rituximab, and plasma exchange. He ultimately recovered normal kidney function and had a favorable renal outcome. This case expands the clinical spectrum of overlapping anti-GBM disease and MN and suggests that patients with MN in remission require long-term serial monitoring for early detection of superimposed autoimmune kidney injury. Individualized immunosuppressive strategies tailored to each patient's clinical characteristics are essential to optimize kidney outcomes in such complex glomerular diseases.

PMID 43016614
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