Klein, Christian Georg and Cicinnati, Vito and Schmidt, Hartmut and Ganten, Tom and Scherer, Marcus N. and Braun, Felix and Zeuzem, Stefan and Wartenberg-Demand, Andrea and Niemann, Gabriele and Schmeidl, Rainer and Beckebaum, Susanne (2013) Compliance and tolerability of subcutaneous hepatitis B immunoglobulin self-administration in liver transplant patients: A prospective, observational, multicenter study. ANNALS OF TRANSPLANTATION, 18. pp. 677-684. ISSN 1425-9524,
Full text not available from this repository. (Request a copy)Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | IMMUNE GLOBULIN; VIRUS INFECTION; PROPHYLAXIS; RECURRENCE; EFFICACY; LAMIVUDINE; SAFETY; PHARMACOKINETICS; IMPACT; HBIg; subcutaneous; HBV; self-injection; home; compliance |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 23 Mar 2020 09:00 |
| Last Modified: | 23 Mar 2020 09:00 |
| URI: | https://pred.uni-regensburg.de/id/eprint/15524 |
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