Efficacy and safety of Niuliva((R)) immune globulin to prevent hepatitis B reinfection inde novo orthotopic liver transplant

摘要

Aims:To determine efficacy and safety of intravenous hepatitis B immune globulin (Niuliva((R)), Grifols) to prevent reinfection inde novo orthotopic liver transplantation.Patients & methods: In a nonrandomized, noncontrolled and Phase III clinical trial, 15 adult patients (12 men) were treated with Niuliva from the anhepatic phase (10,000IU/daily 1 week postsurgery) up to 6 or 12months (5000IU/weekly 1month; 5000IU/monthly thereafter). Results: No patients showed reinfection throughout the study. Niuliva was effective in maintaining antibody titers above the thresholds recommended by the European Medicines Agency (EMA) to prevent reinfection (100-150IU/l). Four serious adverse events were reported in three patients (none related to the study product). There were no seroconversions and no deaths. Conclusion: Long-term, high-dose Niuliva administration was safe and effective to prevent graft reinfection in the tested patients.