Christian Georg Klein1, Vito Cicinnati2, Hartmut Schmidt3, Tom Ganten4, Marcus N Scherer5, Felix Braun6, Stefan Zeuzem7, Andrea Wartenberg-Demand8, Gabriele Niemann9, Rainer Schmeidl10, Susanne Beckebaum1. 1. Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany. 2. Department of Gastroenterology and Hepatology, University Hospital Essen, Essen, Germany. 3. Department of Transplant Medicine, University Hospital Münster,, Münster, Germany. 4. Department of Medicine, Division of Gastroenterology, University Hospital Heidelberg, Heidelberg, Germany. 5. Department of Surgery and Transplantation Surgery, University Hospital Regensburg, Regensburg, Germany. 6. Department of General, Visceral and Transplantation Surgery, University Hospital Kiel, Kiel, Germany. 7. Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt/Main, Germany. 8. Department of Corporate Clinical Research, Biotest AG, Dreieich, Germany. 9. Biotest AG, Department of Corporate Clinical Research. 10. Department of Corporate Drug Safety, Qualified Person for Pharmacovigilance, Biotest AG, Dreieich, Germany.
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 AND 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.
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 AND 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.
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