Background:Hepatitis B immunoglobulin(HBIG)administration is the backbone for prophylaxis of HBV re-infection after liver transplantation (LT).Long term effects and efficacy of HBIG are well known only for intravenous(IV)and intramuscular(IM)formulations. Aim:to investigate efficacy,safety and feasibility of “on demand” subcutaneous (SC) administration of the new formulation of HBIG BT088 (Zutectra®)LT patients. Materials and methods:a total of 37 LT patients(9F,28M,mean age60±7years)were switched from IV or IM to SC HBIG administration during a period of 2 years from January 2011.The conversion to SC administration occurred at a mean time of 44 months from the LT. They were prospectively enrolled and followed up for at least 48 weeks.The dose of HBIG was initially standardized to 1000IU/week.After a period of stabilization, patients were offered a“on demand”approach,with a targeted level of serum antiHBs of minimum100UI/L. Results:all patients were HBV-DNA negative at the time of transplantation(5spontaneously- 14%,32 under NUCs -86%).All patients were on a combination prophylaxis with HBIG and NUCs.All patients became rapidly independent for the weekly SC selfinjection. The treatment was effective in maintaining trough anti- HBs levels greater than 100 UI/l in all patients. 90%of patients showed a mean HBsAb titer greater than 155 UI/l.Overall, mean values of HBsAb were 262 UI/l(±118).The mean HBsAb titre prior to switching to SC formulation was 318±124, with a mean monthly injection of 5000U/L.No drug related side effects or injection site problems were observed. Conclusions: SC HBIG for long term prophylaxis of post LT HBV re-infection has proven to be safe, well-accepted and effective in maintaining the targeted protective anti-HBs levels. Moreover individualization of immuneprophylaxis according to the lowest protective anti-HBs titers is easily applicable with the SC formulation, allowing the exploration of new schedules in order to improve costs while maintaining efficacy.
Pecere, S., Grisolia, A., Pasulo, L., Baldan, A., Rota, M., Colledan, M., et al. (2013). Safety and Efficacy of Subcutaneous Hepatitis B Immunoprophylaxis using" on demand" Approach: A Single Center Experience. HEPATOLOGY, 58(Suppl 1), 1032A-1033A.
|Citazione:||Pecere, S., Grisolia, A., Pasulo, L., Baldan, A., Rota, M., Colledan, M., et al. (2013). Safety and Efficacy of Subcutaneous Hepatitis B Immunoprophylaxis using" on demand" Approach: A Single Center Experience. HEPATOLOGY, 58(Suppl 1), 1032A-1033A.|
|Tipo:||Abstract in rivista|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||No|
|Titolo:||Safety and Efficacy of Subcutaneous Hepatitis B Immunoprophylaxis using" on demand" Approach: A Single Center Experience|
|Autori:||Pecere, S; Grisolia, A; Pasulo, L; Baldan, A; Rota, M; Colledan, M; Fagiuoli, S|
|Data di pubblicazione:||2013|
|Appare nelle tipologie:||01 - Articolo su rivista|