title: Compliance and tolerability of subcutaneous hepatitis B immunoglobulin self-administration in liver transplant patients: a prospective, observational, multicenter study.
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.
  
  
  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.
authors: Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany.
authors: Christian Georg
authors: CG
authors: Klein
authors: Department of Gastroenterology and Hepatology, University Hospital Essen, Essen, Germany.
authors: Vito
authors: V
authors: Cicinnati
authors: Department of Transplant Medicine, University Hospital Münster,, Münster, Germany.
authors: Hartmut
authors: H
authors: Schmidt
authors: Department of Medicine, Division of Gastroenterology, University Hospital Heidelberg, Heidelberg, Germany.
authors: Tom
authors: T
authors: Ganten
authors: Department of Surgery and Transplantation Surgery, University Hospital Regensburg, Regensburg, Germany.
authors: Marcus N
authors: MN
authors: Scherer
authors: Department of General, Visceral and Transplantation Surgery, University Hospital Kiel, Kiel, Germany.
authors: Felix
authors: F
authors: Braun
authors: Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt/Main, Germany.
authors: Stefan
authors: S
authors: Zeuzem
authors: Department of Corporate Clinical Research, Biotest AG, Dreieich, Germany.
authors: Andrea
authors: A
authors: Wartenberg-Demand
authors: Biotest AG, Department of Corporate Clinical Research.
authors: Gabriele
authors: G
authors: Niemann
authors: Department of Corporate Drug Safety, Qualified Person for Pharmacovigilance, Biotest AG, Dreieich, Germany.
authors: Rainer
authors: R
authors: Schmeidl
authors: Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany.
authors: Susanne
authors: S
authors: Beckebaum
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D006801:Humans; D055103:Hypodermoclysis; D007136:Immunoglobulins / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D012646:Self Administration; D016896:Treatment Outcome
chemical_list: D007136:Immunoglobulins; C045213:hepatitis B hyperimmune globulin