title: Safety and efficacy of subcutaneous hepatitis B immunoglobulin after liver transplantation: an open single-arm prospective study.
abstract: Life-long hepatitis B immunoglobulin (HBIG) administration is a main component of prophylactic strategy to prevent hepatitis B virus (HBV) reinfection after liver transplantation (LT). Long-term effects of HBIG treatment are known only for intravenous (IV) and intramuscular formulations. To evaluate safety and efficacy of self-administered SC HBIG, 135 LT patients receiving a 48-week treatment were analyzed. The dose of HBIG was 500 IU or 1000 IU if body weight was <75 kg or ≥75 kg, respectively. Patients were switched from the monthly IV HBIG treatment to weekly SC HBIG 2-3 weeks after the last IV dosage. All patients were able to SC self-injection after a single training. The treatment was effective in maintaining trough anti-HBs levels >100 IU/L. No severe drug-related side effects occurred. Fifteen injection-site small hematomas and four cases of mild itch occurred. At the end of the study, anti-HBs median titer was 232 IU/L (115-566 IU/L) and 97.8% of patients had an anti-HBs level >150 IU/L. Due to high mean level of anti-HBs titers observed during this study, individualized treatment schedules should be further investigated. In conclusion, SC HBIG for long-term prophylaxis of post-LT HBV reinfection resulted safe, well accepted, and effective in maintaining adequate anti-HBs levels.
authors.affiliation: Liver Unit, Cardarelli Hospital, Napoli, Italy. ggdicostanzo@libero.it
authors.forename: G G
authors.initials: GG
authors.lastname: Di Costanzo
authors.forename: A G
authors.initials: AG
authors.lastname: Lanza
authors.forename: F P
authors.initials: FP
authors.lastname: Picciotto
authors.forename: M
authors.initials: M
authors.lastname: Imparato
authors.forename: C
authors.initials: C
authors.lastname: Migliaccio
authors.forename: M
authors.initials: M
authors.lastname: De Luca
authors.forename: V
authors.initials: V
authors.lastname: Scuderi
authors.forename: R
authors.initials: R
authors.lastname: Tortora
authors.forename: G
authors.initials: G
authors.lastname: Cordone
authors.forename: W
authors.initials: W
authors.lastname: Utech
authors.forename: F
authors.initials: F
authors.lastname: Calise
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D019259:Lamivudine / Q000627:therapeutic use; D016031:Liver Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012646:Self Administration; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D007136:Immunoglobulins; D019259:Lamivudine; C045213:hepatitis B hyperimmune globulin