Compliance and tolerability of subcutaneous hepatitis B immunoglobulin self-administration in liver transplant patients: a prospective, observational, multicenter study.

Background: Subcutaneous self-administration of hepatitis B immunoglobulin (HBIg) prophylaxis is preferred by patients, but compliance with the assigned regimen in routine practice is undocumented. Material/Methods: A prospective, observational, 18-week, open-label, single-arm, multicenter study assessed compliance and tolerability in maintenance liver transplant patients self-administering subcutaneous HBIg at home according to local practice. Results: Sixty-one patients were analyzed (median follow-up 18 weeks, range 14.0-27.9 weeks), with 961/1006 injections (95.5%) administered at home during the study. Other than in 4 patients, HBIg was prescribed for weekly administration (500 IU/L, n=39; 1000 IU/L, n=18) at study entry. Eighteen patients (29.5%) were assigned a dose lower than recommended in the Summary of Product Characteristics. The primary variable of compliance failure, defined as >= 1 hepatitis B surface antibody (anti-HBs) serum trough level <100 IU/L, occurred in 4 patients (6.6%; 95% CI 1.8%, 15.9%), 3 of whom were receiving a dose below that recommended for their body weight. Anti-HBs levels exceeded 100 IU/L in all patients at the final visit. Mean (SD) anti-HBs level at the first and final study visits was 248 (97) IU/L and 255 (104) IU/L, respectively. Patient compliance was graded good or very good by physicians in 91.8% of cases. No patients tested positive for HBsAg or HBV-DNA. Four patients experienced >= 1 adverse drug reactions, none of which was serious. No patient discontinued HBIg due to adverse events. Conclusions: Subcutaneous HBIg home-based self-administration under routine, real-life conditions is well-tolerated and associated with high compliance and maintaining protective anti-HBs serum concentration.