Drug intelligence / Profile preview

hepatitis B immunoglobulin

Development stage
Approved
Lead developer
Region Midtjylland
Modality
Antibody-Based Therapeutics
Administration
Intravenous, Intramuscular, Subcutaneous
01

Overview

Hepatitis B immunoglobulin (HBIG) is a polyclonal antibody preparation derived from human plasma containing high titers of antibodies against the hepatitis B surface antigen (anti-HBs). While traditionally utilized for post-exposure prophylaxis and the prevention of hepatitis B recurrence following liver transplantation, Region Midtjylland (specifically Aarhus University Hospital) has investigated its therapeutic potential for the treatment of chronic hepatitis B infection. The mechanism of action involves the binding and neutralization of circulating hepatitis B surface antigen (HBsAg), which is intended to reduce the viral burden and potentially alleviate the immune exhaustion characteristic of chronic HBV. In clinical trials led by Region Midtjylland, HBIG is typically administered intravenously, often in combination with nucleos(t)ide analogues, to evaluate its ability to induce a functional cure, defined by the sustained loss of HBsAg.

Brand names
AunativHepatect CPZutectraBayHep BNabi-HBHepaGam BHyperHEP B
Other names
HBIGanti-hepatitis B antibodiesanti-HBshepatitis B immune globulinanti-hepatitis B surface antigen antibodies
02

Targets

HBsAg (Hepatitis B surface antigen)

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