Efficacy and safety of Niuliva® immune globulin to prevent hepatitis B reinfection in de novo orthotopic liver transplant

Autor:	F. Di Benedetto, M Barcelò, U. Cillo, Mauro Salizzoni, P De Simone, Antonio Páez, Mk Woodward
Rok vydání:	2019
Předmět:	recurrence biology business.industry Orthotopic Liver Transplant anhepatic phase ® Hepatitis B medicine.disease HBIG hepatitis B virus intravenous Niuliva orthotopic liver transplantation reinfection Virology Immunology biology.protein Medicine Antibody business
Zdroj:	Future Virology. 14:85-94
ISSN:	1746-0808 1746-0794
DOI:	10.2217/fvl-2018-0139
Popis:	Aims: To determine efficacy and safety of intravenous hepatitis B immune globulin (Niuliva®, Grifols) to prevent reinfection in de 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 (10,000 IU/daily 1 week postsurgery) up to 6 or 12 months (5000 IU/weekly 1 month; 5000 IU/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 (100–150 IU/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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::19954aa17ae69adc9a7fdb3bfb7bb89a https://doi.org/10.2217/fvl-2018-0139 Zobrazit plný text záznamu