Subcutaneous Administration of Anti-Hepatitis B Antibodies

A method for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus, comprising administering to a subject in need thereof a dose of anti-hepatitis B immunoglobulin sufficient to obtain a predetermined level of anti-hepatitis B antibodies in the circulation of said subject, the improvement wherein the anti-hepatitis B immunoglobulin is administered by the subcutaneous route in a dose that is at least 1.5 times higher than the intramuscular formulated dose needed to obtain said predetermined level of anti-hepatitis B antibodies in the circulation of said subject, wherein said predetermined level is obtained in the circulation by the subcutaneous dose at a similar timing as in said intramuscular formulated dose.

A method for preventing hepatitis B viral infection recurrence in a subject who underwent orthotopic liver transplantation (OLT), comprising administering to said subject a dose of anti-hepatitis B immunoglobulin sufficient to obtain a predetermined level of anti-hepatitis B antibodies in the circulation of said subject, the improvement wherein the anti-hepatitis B immunoglobulin is administered by the subcutaneous route in a dose that is at least 1.5 times higher than the intramuscular formulated dose needed to obtain a similar level of anti-hepatitis B antibodies in the circulation of said subject, wherein said predetermined level is obtained in the circulation by the subcutaneous dose at a similar timing as in said intramuscular formulated dose.

A method for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus in a subject in need thereof, the method comprising a first dosing regimen of intramuscular administration of anti-hepatitis B immunoglobulin, followed by a second dosing regimen, which comprises subcutaneously administering to the subject a dose of anti-hepatitis B immunoglobulin that is higher than the dose employed by the first dosing regimen of intramuscular administration, thereby obtaining anti-hepatitis B antibodies in the circulation of said subject at a similar level and timing as in the first dosing regimen of intramuscular administration.