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lyophilized hepatitis-B human immunoglobulin

✓ Approved

Tonrol Bio-Pharmaceutical · Polyclonal Antibodies · Polyclonal Antibodies

What is lyophilized hepatitis-B human immunoglobulin?

lyophilized hepatitis-B human immunoglobulin is a polyclonal antibodies developed by Tonrol Bio-Pharmaceutical. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

CompanyTonrol Bio-Pharmaceutical
Drug ClassPolyclonal Antibodies, Vaccine, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Tonrol Bio-Pharmaceutical

Therapeutic Indications

lyophilized hepatitis-B human immunoglobulin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedMicrobiology spectrum2026-11-11

Evaluation of point-of-care testing (POCT) for blood-borne infections in forensic autopsy specimens.

Kim Ga Eun GE, Lee Dong Yeon DY, Jung Eun-Byoul E-B, Lim Sojung S et al.

Lateral flow immunoassay (LFIA)-based point-of-care testing (POCT) for viral antigen and antibody detection enables rapid screening for blood-borne viral infections and may be particularly valuable in forensic autopsy settings, where incomplete antemortem medical histories and invasive procedures increase the risk of occupational exposure. However, its performance in postmortem specimens remains unclear. We evaluated the applicability of LFIA-based POCT for detecting human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) in autopsy specimens, focusing on postmortem decomposition and the use of solid organ tissues as alternatives to blood. A total of 309 cases were analyzed using LFIA and quantitative polymerase chain reaction (qPCR) across blood, liver, and spleen specimens. Agreement was assessed using overall, positive, and negative percent agreement and Cohen's kappa coefficient (κ). Positivity rates were compared by specimen type and decomposition status. LFIA agreement with qPCR varied by marker and specimen type, with substantial agreement for HIV and HCV antibody detection in blood and lower agreement in liver and spleen. Fresh specimens generally demonstrated higher LFIA positivity rates than decomposed specimens. Among specimens meeting predefined qPCR positivity criteria, LFIA-positive specimens tended to exhibit higher viral loads than LFIA-negative specimens, reaching statistical significance for HBV in liver, with similar but non-significant trends for blood HBV and liver HCV. LFIA-based POCT may serve as a preliminary screening tool in postmortem settings, particularly when blood is available. Nevertheless, negative results do not exclude infection-especially with low viral loads or advanced decomposition-and should be confirmed by molecular testing.IMPORTANCEForensic personnel performing autopsies face significant occupational risks from exposure to blood-borne viruses, including human immunodeficiency virus, hepatitis B virus, and hepatitis C virus. Unlike clinical settings, forensic autopsies frequently involve bodies with unknown infection histories, making rapid infection screening essential for personnel safety. Lateral flow immunoassay (LFIA)-based point-of-care testing (POCT) for viral antigen and antibody detection offers a rapid, infrastructure-free screening option; however, its performance in postmortem specimens has not been systematically evaluated. This study suggests that rapid immunochromatographic POCT may serve as a preliminary screening tool in forensic autopsy settings, particularly when blood specimens are available. However, a negative result does not exclude infection, especially in cases with low viral load or advanced decomposition, and confirmatory molecular testing remains necessary. These findings provide practical guidance for forensic professionals on appropriate specimen selection and interpretation of LFIA results, ultimately supporting safer autopsy practices.

PMID 43012444
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PubMedMedicine2026-11-11

Syphilitic proctitis with profuse rectal bleeding in an HIV-infected patient with preserved CD4 count (case report).

Mosi Mohamad H MH, Alfarra Hisham H, Davi Chandni C, Saaki Shaila S et al.

Syphilitic proctitis is an uncommon and frequently under-recognized manifestation of Treponema pallidum infection that can closely mimic inflammatory, infectious, or neoplastic rectal disease. We report an unusually severe, hemorrhagic presentation in a patient with human immunodeficiency virus (HIV) and a preserved cluster of differentiation 4 (CD4) count, a setting in which overlapping etiologies often delay the diagnosis. A heterosexual man in his early 50s with untreated HIV infection and chronic hepatitis B-related cirrhosis (Child-Pugh class B) presented with sudden onset of profuse hematochezia, watery diarrhea, abdominal cramping, and fatigue. Computed tomography angiography revealed pronounced rectal wall thickening with deep ulceration. Colonoscopy demonstrated an indurated, ulcerated rectal lesion, and biopsy showed dense lymphoplasmacytic inflammation, with spirochetes confirmed by T pallidum immunohistochemistry. Negative cytomegalovirus (CMV) immunohistochemistry, undetectable CMV DNA in plasma and rectal tissue, and a preserved CD4 count (445 cells/µL) made CMV proctitis unlikely. The overall clinical, endoscopic, and histologic findings supported a diagnosis of syphilitic proctitis. Management included doxycycline 100 mg twice daily for 2 weeks, selected because of the patient's documented penicillin allergy. Antiretroviral therapy with bictegravir/tenofovir alafenamide/emtricitabine was initiated to treat HIV and provide concurrent hepatitis B coverage. Within 2 weeks, the patient experienced complete resolution of hematochezia and diarrhea. At 3-month follow-up, the CD4 count had risen to 570 cells/µL, HIV RNA was undetectable (<20 copies/mL), and the rapid plasma reagin titer had declined from 1:512 to 1:32. This case underscores that syphilitic proctitis may manifest with severe ulcerative disease even in patients with relatively preserved immune function. Clinicians should maintain vigilance for syphilis in individuals with HIV who present with rectal bleeding or proctitis to prevent diagnostic delays and ensure timely therapy.

PMID 43012798
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PubMedFrontiers in bioengineering and biotechnology2026-11-11

Lyophilized pathogen-inactivated platelet lysate enriched hydrogel for cartilage tissue engineering.

Boretti Gabriele G, Tiainen Hanna H, Marczak Anna A, Hamzehpour Helena H et al.

Platelet-derived products are increasingly investigated for cartilage regeneration because of their high content of bioactive factors. While rapid clearance after direct injection has been partly addressed by hydrogel encapsulation, many platelet-enriched hydrogels still rely on variably processed platelet derivatives, leaving challenges in standardization and storage stability. Here, we developed a gelatin-based hydrogel enriched with lyophilized, pathogen-inactivated human platelet lysate (L-PIPL) as an off-the-shelf platelet-derived reservoir for localized delivery of chondrogenic cues. L-PIPL was produced from expired pathogen-inactivated platelet units by freeze-thaw lysis and lyophilization, then incorporated into a gelatin-based hydrogel at 5, 10, and 15% (w/v). Composite hydrogels were characterized by scanning electron microscopy (SEM), attenuated total reflectance Fourier-transform infrared spectroscopy (ATR-FTIR), rheology, transforming growth factor beta 1 (TGF- β 1) release, and soluble protein analysis. Cytocompatibility and early chondrogenic response were assessed in extruded, crosslinked cell-laden constructs using C20A4 chondrocytes and adipose-derived mesenchymal stromal cells (AD-MSCs). L-PIPL preserved the core hydrogel chemistry while modulating microarchitecture and viscoelastic properties. Moderate enrichment, particularly 5%-10% (w/v), maintained gel-like behavior and cytocompatibility, whereas 15% L-PIPL reduced network stability and cell viability. Release of bioactive factors was dose-dependent, with an initial burst followed by slower release over time. In AD-MSC-laden constructs, L-PIPL increased metabolic activity, with the 10% formulation showing the highest activity, and the 5% formulation showing the most favorable early chondrogenic commitment. L-PIPL-enriched hydrogels provide a standardized, cytocompatible, and bioactive matrix for localized delivery of platelet-derived factors. Overall, 5% L-PIPL emerged as the most promising formulation for further development in cartilage tissue engineering.

PMID 43011283
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PubMedSouthern African journal of HIV medicine2026-11-11

A retrospective study of HIV and hepatitis B co-infection at a tertiary hospital in the Western Cape province of South Africa.

Hugo Alida M AM, Lovelock Tamsin T, Taljaard Jantjie J JJ

HIV and hepatitis B virus (HBV) coinfection is a clinical concern because of shared transmission routes and accelerated liver disease progression. Data from sub-Saharan Africa (SSA) remain limited. To describe the clinical, laboratory, radiological, and outcome characteristics of adults with chronic HIV/HBV coinfection attending a tertiary hospital in South Africa. A retrospective observational study of adults with HIV and chronic HBV infection attending an infectious diseases clinic between 01 January 2019 and 31 October 2024. Chronic HBV was defined as hepatitis B surface antigen positivity for at least 6 months. Eligible patients had at least two clinic visits. Data were extracted from clinical, laboratory, imaging, and pharmacy records. Of the 179 patients screened, 140 met inclusion criteria. The cohort had a female predominance of 51.4% and a median age of 42 years; most were diagnosed through routine HIV care. The median CD4 count was 214 cells/μL, and many had advanced immunosuppression. Most were receiving antiretroviral therapy (ART), with 78.8% on tenofovir (TDF)-based regimens. HIV and HBV viral load (VL) was low, and the median HBV VL was 81 IU/mL. Liver assessment showed that 36.3% had an abnormal Aspartate Aminotransferase to Platelet Ratio Index score and 40.2% had an elevated liver stiffness measurement (> 7 kPa) suggestive either of significant fibrosis or cirrhosis. Fifteen patients died, 3 of whom died from HBV-related causes. Retention in care was poor, with only one-third remaining in follow-up. Chronic HBV remains an important comorbidity among people living with HIV in South Africa, particularly in those born before widespread vaccination. Despite high ART coverage, important gaps remain in fibrosis assessment and retention in care. Strengthening prevention, vaccination, diagnostic access, and continuity of care is essential to reduce HBV-related morbidity and mortality.

PMID 43011457
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PubMedLiver international : official journal of the International Association for the Study of the Liver2026-11-11

The Nucleoside Analogue NITD008, Alone or Combined With Ribavirin, Potently Reduces Hepatitis E Virus Infection in Humanised Mice.

Volmari Annika A, Hinte Florian F, Volz Tassilo T, Chen Junfei J et al.

Hepatitis E virus (HEV) infection is becoming increasingly clinically relevant worldwide, but no approved antiviral therapy currently exists. Ribavirin (RBV) is used off-label for immunosuppressed patients with chronic hepatitis E, although it is effective in only 80% of patients and linked to side effects. The nucleoside analogue NITD008 was shown to be effective against a broad range of RNA viruses. We aimed to evaluate the efficacy of NITD008, alone or in combination with RBV, in humanised mice stably infected with HEV. Mice received either NITD008 alone (20 mg/Kg/day) by oral gavage for up to 2 weeks, or 5 mg/Kg NITD008 alone or in combination with RBV (50 mg/Kg). Viral changes were determined in faeces, blood and intrahepatically. NITD008 efficiently reduced HEV loads to undetectable levels in serum and by > 4log10 in faeces within 1 week. Intrahepatic analysis showed a ∆log10: 2.5 reduction in HEV RNA levels in treated mice compared to controls after 2 weeks. Imaging showed fewer HEV-RNA-positive human hepatocytes in treated mice. NITD008 did not increase serum markers of hepatocyte death. Combination therapy induced stronger suppression of HEV RNA in faeces (∆log10: 5.02) than RBV monotherapy (∆log10: 1.08), despite lower NITD008 doses. This study demonstrates the non-toxicity of NITD008 towards human hepatocytes and more potent antiviral activity compared to RBV in HEV-infected mice. Combination regimens with RBV showed strong additive activity. The study suggests that HEV clearance may be achieved in immunosuppressed patients by using and further developing this class of direct antiviral drugs.

PMID 43012094
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PubMedActa neurochirurgica2026-11-11

Bone flap resorption after autologous cranioplasty for traumatic brain injury: a case-control study in Vietnam.

Pham Huy Ngoc HN, Tien Anh Nguyen Cong NC, Nguyen Linh Khanh LK, Ha Son Hong SH et al.

Autologous bone is a commonly used material for cranioplasty following decompressive craniectomy; however, it is accompanied by the inherent risk of resorption. This study aimed to identify factors associated with bone flap resorption (BFR) in patients undergoing autologous cranioplasty after decompressive craniectomy for traumatic brain injury. A matched case-control study was conducted at Viet Duc University Hospital between January 2022 and July 2025. Cases were defined as patients who developed severe BFR requiring revision surgery. Each case was matched with two controls without BFR based on cranioplasty date and follow-up duration. The association of demographic, general health, trauma history and peri-cranioplasty characteristics with BFR was assessed using conditional logistic regression. A total of 71 cases and 142 matched controls were included in this study. BFR that required surgical revision occurred predominantly within two years after cranioplasty (90%). The mean time interval from cranioplasty to complication diagnosis was 444 ± 212 days. Large-sized bone flap (OR: 3.96, 95% CI: 1.86-8.43), fragmented bone flap (OR: 7.84, 95% CI: 1.38-44.53), and chronic viral hepatitis (either B or C) (OR: 4.32, 95% CI: 1.54-12.15) were independent associated factors of BFR. Young age (< 18), frontal sinus fracture, and ventriculoperitoneal shunt implantation showed a trend to increase risk of BFR but failed to reach statistical significance in multivariate analysis. In our study, bone fragmentation, large bone flap size, and chronic viral hepatitis were associated with increased risk of bone flap resorption after autologous cranioplasty in TBI patients. Further studies are necessary to confirm these findings, especially concerning the role of chronic viral hepatitis.

PMID 43009631
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