Evaluation of Anti-HBs Serum Levels and Pharmacokinetic Profile After Intravenous Administration of Niuliva, a New Hepatitis B Immunoglobulin, Following Liver Transplantation

• Published in: Transplantation proceedings 2009-12, Vol.41 (10), p.4253-4258
• Main Authors: Mas, A, Castells, L, Abradelo, M, Bernardos, Á, Páez, A, Woodward, M.K, Sousa, J.M
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Biological and medical sciences; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Hepatitis B - complications; Hepatitis B - immunology; Hepatitis B - surgery; Hepatitis B Antibodies - blood; Hepatitis B Antibodies - immunology; Hepatitis B Surface Antigens - blood; Hepatitis B Surface Antigens - immunology; Human viral diseases; Humans; Immunoglobulins - immunology; Immunoglobulins - therapeutic use; Infectious diseases; Life Expectancy; Liver Transplantation - immunology; Liver, biliary tract, pancreas, portal circulation, spleen; Medical sciences; Middle Aged; Patient Selection; Prospective Studies; Safety; Surgery; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Tissue, organ and graft immunology; Viral diseases; Viral hepatitis; Young Adult
• ISSN: 0041-1345; 1873-2623
• DOI: 10.1016/j.transproceed.2009.09.083

Abstract Purpose 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.