Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients

BACKGROUND:

Hepatitis B Immune Globulin (HBIG) is used post liver transplantation (OLT) in hepatitis B
surface antigen-positive recipients to prevent recurrence of hepatitis B. One formulation of
HBIG, HepaGam B, contains the disaccharide maltose, which can potentially falsely elevate
glucose readings when glucose nonspecific point of care (GNSPOC) testing is used, such as a
glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)-based method. This can result in
inappropriate administration of antidiabetic agents and resultant episodes of clinically
significant hypoglycemia. Glucose specific point of care (GSPOC) testing, such as a glucose
oxidase-based method, however, is not affected by the presence of maltose. The purpose of
this study was to determine if there was a significant difference in glucose readings using
GSPOC and GNSPOC monitoring devices after HBIG administration.

METHODS:

This is a nonrandomized, prospective study evaluating patients receiving maintenance HBIG
therapy over 3 months post liver transplantation. Blood glucose levels in each subject were
analyzed by GSPOC and GNSPOC devices at specific times around HBIG administration.

Inclusion Criteria:

- written informed consent

- HBsAG positive candidates for HBV related liver transplant to be placed on HepaGam B
therapy for the prevention of HBV recurrence in both the acute phase (immediately
post operative) and the long term maintenance phase

- at least 18 years of age

Exclusion Criteria:

- unable or unwilling to provide written informed consent

- concomitant administration of other maltose containing products such as dietary
supplements, dietary aids, IVIG, external peritoneal dialysis solution in both arms

- concomitant administration of corticosteroids in the long term maintenance phase

- pregnancy, as determined by a pregnancy test administered after consent has been
signed