Evaluation of Anti-HBs serum levels and pharmacokinetic profile after intravenous administration of Niuliva, a new hepatitis B immunoglobulin, following liver transplantation.
OBJECTIVE
We assessed whether trough anti-hepatitis B surface antigen (HBs) serum levels considered to be protective (>100 IU/L) were maintained in liver transplanted patients after 6 months of uninterrupted treatment with Niuliva, a new intravenous HBIg.


METHODS
Twenty patients, aged 18-70 years, who had undergone liver transplantation due to HBV-related liver disease at least 1 year before inclusion were enrolled in a prospective, open-label, uncontrolled, multicenter clinical study. A fixed monthly dose of 5,000 IU of study medication was administered intravenously for 6 months.


RESULTS
After the second infusion, all mean values of anti-HBs and 95% CIs were above the limit of 100 IU/L considered to be protective. The percentages of success ranged between 95% (95% CI 75.1%-99.9%) and 100% (95% CI 86.1%-100%). Mean values and 95% CI of in vivo recovery of anti-HBs at 15-30 minutes after each infusion showed overlaps between all intervals, which indicated that significant differences were not present in the recovery of post infusion anti-HBs in vivo. There were no recurrences of HBV infection during the study. There were no seroconversions in patients previously negative to hepatitis C virus or HIV. No serious adverse events related to the study medication were observed.


CONCLUSIONS
Serum levels of anti-HBs after using Niuliva in patients who had undergone liver transplantation were protective in 95%-100% of cases after the study period. This new HBIg showed the expected pharmacokinetic profile and was well tolerated and safe.
Mas
A
A
Servei d'Hepatologia, Hospital Clínic i Provincial de Barcelona, Villarroel 170, E-08035 Barcelona, Spain. amas@clinic.ub.es
Castells
L
L
Abradelo
M
M
Bernardos
A
A
Páez
A
A
Woodward
M K
MK
Sousa
J M
JM
D000293:Adolescent; D000328:Adult; D000368:Aged; D006509:Hepatitis B / Q000150:complications / Q000276:immunology / Q000601:surgery*; D006510:Hepatitis B Antibodies / Q000097:blood* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood / Q000276:immunology; D006801:Humans; D007136:Immunoglobulins / Q000276:immunology / Q000627:therapeutic use*; D008017:Life Expectancy; D016031:Liver Transplantation / Q000276:immunology; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D012449:Safety; D055815:Young Adult
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D007136:Immunoglobulins; C045213:hepatitis B hyperimmune globulin