Delving into the Latest Updates on HBIG with Synapse

Overview

Basic Info

Drug Type

Immunoglobulin

Synonyms

HBIG, HBIG (Grifols), Hepabulin Antibody injection

+ [9]

Target-

Mechanism

Immunomodulators

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis B

Inactive Indication

Hepatitis B, Chronic

Originator Organization

Grifols SA

Active Organization

Grifols SA

Inactive Organization

Instituto Grifols SA

Drug Highest PhaseApproved

First Approval Date

ES (01 Jan 2012),

Hepatitis B

Regulation-

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Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.

Start Date01 Dec 2016

Sponsor / Collaborator

University of Arizona

NCT02901418 / Unknown statusNot ApplicableIIT

According to the Venous Blood HBsAg State of Neonatus at Birth, Discussing the Efficiency of Personalized Blocking Method of HBV Maternal-neonatal Transmission in High-risk Newborns

Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately after birth is the most important method of blocking mother-to-child transmission of HBV. However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have a failure rate as high as 5%
15%.There are numerous studies to explore pregnancy women with HBV positive, especially high viral load of those women during pregnancy being treated with nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous blood HBsAg state of neonatus at birth.

Start Date01 Jul 2015

Sponsor / Collaborator

Beijing Ditan Hospital

NCT02417207 / Unknown statusPhase 4IIT

Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation

The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.

Start Date01 Apr 2015

Sponsor / Collaborator

The Third Affiliated Hospital, Sun Yat-Sen University

100 Clinical Results associated with HBIG

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100 Translational Medicine associated with HBIG

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100 Patents (Medical) associated with HBIG

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1,139

Literatures (Medical) associated with HBIG

01 Dec 2024·Vaccine

A prospective, multicenter study of hepatitis B birth-dose vaccine with or without hepatitis B immunoglobulin in preventing mother-to-child transmission of hepatitis B virus in Ethiopia

Article

Author: Osman, Mahlet ; Teklehaymanot, Tilahun ; Arefaine, Mebrihit ; Mihret, Adane ; Mulu, Andargachew ; Berhe, Nega ; Alemayehu, Dawit Hailu ; Johannessen, Asgeir

BACKGROUNDHistorically, mother-to-child transmission (MTCT) of hepatitis B virus (HBV) was considered uncommon in Africa, leading to a reluctant attitude to birth-dose HBV vaccination on the continent. As a randomized trial would be unethical, real-life data are needed to assess the effect of HBV birth-dose vaccine in Africa.METHODSA multicenter, prospective, observational study of hepatitis B surface antigen (HBsAg)-positive pregnant women and their infants was carried out in Ethiopia, from January 2019 to May 2021. Pregnant women were screened for HBsAg and HIV as part of routine antenatal care and/or delivery, and HBsAg-positive HIV-negative pregnant women were included in the study. HBV birth-dose vaccine and hepatitis B immunoglobulin (HBIg) were recommended but not all newborns received it as it was not national policy. All infants, however, received the pentavalent HBV vaccine at 6, 10, and 14 weeks of age. Vaccination status was confirmed from delivery ward charts and infant vaccination certificates. Infants were tested for HBsAg at 9 months of age and a positive result was taken as evidence of MTCT.FINDINGSOf 290 HBsAg-positive pregnant women, 168 mother/infant pairs returned for their 9-month follow-up visit and were included in this analysis. Two of 112 (1.8 %) infants who received birth-dose vaccine with HBIg, and 2 of 23 (8.7 %) who received birth-dose vaccine alone were HBsAg positive at nine months of age, compared to 8 of 33 (24.2 %) who received neither vaccine nor HBIg at birth (p = 0.002). High maternal viral load (>200,000 IU/ml; adjusted odds ratio [AOR] 10.4; 95 % confidence interval [CI] 1.2-92.1) and not receiving HBV birth-dose vaccine nor HBIg (AOR 29.2; 95 % CI 4.0-211.3) were independent predictors of MTCT.INTERPRETATIONBirth-dose HBV vaccine with or without HBIg significantly reduced the risk of MTCT of HBV in Ethiopia. Improved coverage of birth-dose HBV vaccine should be an urgent priority.

01 Sep 2024·Journal of Paediatrics and Child Health

Prevention of vertical transmission of hepatitis B: A retrospective review of a 5‐year maternal–infant cohort in London

Article

Author: O'Mahony, Elizabeth ; Raghunanan, Sophie ; Foster, Caroline ; Brown, Ashley

AimsThe World Health Organization (WHO) estimates that 3.5% of the population live with hepatitis B virus (HBV); migrants to Europe are disproportionately affected. UK birth dose HBV vaccination is limited to infants born to those living with HBV (LWHBV). High‐risk infants (high maternal infectivity, low birthweight) also receive HBV immunoglobulin (HBIG). The Family Hepatitis Clinic follows infants and those LWHBV working towards WHO goals of combating viral hepatitis by 2030.MethodsA trust‐wide electronic note review of outcomes for infants born to those LWHBV (2016–2020).ResultsTwo hundred and eighty‐three infants, 134 (47%) females, born to those LWHBV were referred. Two hundred and thirty‐one (82%) attended follow‐up with a vertical transmission rate of 0%. Twenty (7%) individuals LWHBV received tenofovir disoproxil fumerate in pregnancy; median viral load (VL) at initiation 125 416 376 DNA IU/mL, one having birth VL. Twenty‐eight (10%) infants were stratified as high risk and all received HBIG and birth dose vaccination with 9 (32%) subsequently lost to follow‐up, compared to 48 (19%) low‐risk infants. 267/283 (94%) had birth dose vaccination documented and 206/283 (73%) received at least four vaccine doses. 215/283 (76%) infants had serology by 24 months; 17 (6%) with suboptimal vaccine responses: hepatitis B surface antibody <100 IU/mL. Serology before 18 months resulted in higher rates of maternal hepatitis B core antibody detection (15% vs. 3%).ConclusionPrevention of vertical transmission of HBV was universal in those attending, although high‐risk infants were more likely lost to follow up. HBV post‐vaccine serological protection was comparable with national data from 2021 (77% >4 doses, 77% HBsAb >100).

01 Sep 2024·Transplantation

Efficacy of Newer Nucleos(t)ide Analogs After Hepatitis B Immunoglobulin Discontinuation Against Hepatitis B and D Recurrence in Liver Transplant Recipients

Article

Author: Oikonomou, Theodora ; Cholongitas, Evangelos ; Goulis, Ioannis ; Bafa, Konstantina ; Sinakos, Emmanouil ; Papatheodoridis, George V

Background.The use of nucleos(t)ide analogs (NAs) with a high genetic barrier to resistance, namely entecavir and tenofovir, has improved the efficacy of antiviral prophylaxis against hepatitis B virus (HBV) recurrence after liver transplantation (LT). However, the optimal duration and dosage of hepatitis B immunoglobulin (HBIG) administration, particularly in patients transplanted for HBV and hepatitis D virus (HDV) coinfection, remains controversial.Methods.We evaluated 28 patients transplanted for HBV/HDV cirrhosis. After LT, each patient received a fixed scheme of low-dose HBIG plus NA for 6 mo post-LT and then continued with long-term NA prophylaxis (entecavir: 8, tenofovir: 20 patients).Results.During 72 mo of follow-up, reappearance of hepatitis B surface antigen at low titers was observed in 1 (3.6%) patient at 33 mo after HBIG discontinuation, which became negative after a single dose of HBIG 1000 IU/L, whereas both serum HBV DNA and HDV RNA remained persistently undetectable and without any clinical or biochemical evidence of HBV/HDV recurrence.Conclusions.We showed for the first time the efficacy of a short, fixed scheme of low-dose HBIG plus NA followed by long-term NA monoprophylaxis against HBV/HDV recurrence after LT, although careful follow-up is needed after HBIG discontinuation, whereas further larger studies are needed to confirm these findings.

100 Deals associated with HBIG

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J06BB04	DB05276

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	ES	Grifols SA	01 Jan 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Preclinical	ES	Instituto Grifols SA	01 Oct 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASL2020	Not Applicable	Hepatitis B HBsAg-positive \| anti-HBc positive	1,355	HBIG monotherapy	tgjytwwkrh(cxgitnxovh) = agqiccnwek iyejxglfxu (zqsctkvukv ) View more	Positive	27 Aug 2020
				Combination treatments with antiviral prophylaxis and HBIG	tgjytwwkrh(cxgitnxovh) = zakimzbojf iyejxglfxu (zqsctkvukv ) View more
EASL2019	Not Applicable	Hepatitis B HBeAg status \| maternal HBV DNA load	16,121	100 IU HBIG	bqkewknxad(fpfkwfqcub) = ckssdhxind arzbbznaus (ogtbllyftb, 4% − 9%)	-	13 Apr 2019
				200 IU HBIG	bqkewknxad(fpfkwfqcub) = bamxndtpuy arzbbznaus (ogtbllyftb, 5% − 8%)
EASL2019	Not Applicable	Hepatitis B	18	HBIG and NA therapy	ivezfuopqq(edogrrshpk) = kuwgcjjdlw emvcsgioje (fbrhnsbqli ) View more	-	12 Apr 2019
				NA therapy only	ivezfuopqq(edogrrshpk) = tupictrqvq emvcsgioje (fbrhnsbqli ) View more
NCT01131065 (CTgov)	Phase 3	Hepatitis B	15	Hepatitis B immune globulin	oykpqqbltr(lrehudpdwu) = oonwoorxon fonmosgflw (uerraiqets, cchgbxeufn - mdrhxjanwo) View more	-	01 Feb 2016