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Rizza G, Glynou K, Eletskaya M. Impact of hepatitis B immunoglobulin mode of administration on treatment experiences of patients after liver transplantation: Results from an online survey. World J Transplant 2024; 14:90949. [PMID: 39295979 PMCID: PMC11317858 DOI: 10.5500/wjt.v14.i3.90949] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Revised: 05/02/2024] [Accepted: 06/07/2024] [Indexed: 07/31/2024] Open
Abstract
BACKGROUND Hepatitis B immunoglobulin (HBIG) in combination with a potent nucleos(t)ide analog is considered the standard of care for prophylaxis against hepatitis B virus (HBV) reinfection after liver transplantation for HBV-associated disease. AIM To evaluate patients' satisfaction, preferences, and requirements for subcutaneous (SC), intramuscular (IM), and intravenous (IV) HBIG treatments. METHODS A self-completion, cross-sectional, online, 22-question survey was conducted to examine perceptions and satisfaction with current HBIG treatment in adults receiving HBIG treatment following liver transplantation for HBV-associated disease in France, Italy, and Turkey. Hypothetical HBIG products with different administration modes were evaluated using target product profile assessment and a conjoint (trade-off) exercise. RESULTS Ninety patients were enrolled; 32%, 17%, and 51% were SC, IM, and IV HBIG users, respectively. Mean duration of treatment was 36.2 months. SC HBIG had the least negative impact on emotional well-being and social life and was perceived as the most convenient, easiest to administer, least painful, and had the highest self-rating of treatment compliance. More IM HBIG users than SC or IV HBIG users reported that administration frequency was excessive (67%, 28%, and 28%, respectively). In the target product profile assessment, 76% of patients were likely to use hypothetical SC HBIG. In the conjoint exercise, administration route, frequency, and duration were key drivers of treatment preferences. CONCLUSION Ease, frequency, duration, and side effects of HBIG treatment administration were key drivers of treatment preferences, and SC HBIG appeared advantageous over IM and IV HBIG for administration ease, convenience, and pain. A hypothetical SC HBIG product elicited a favorable response. Patient demographics, personal preferences, and satisfaction with HBIG treatment modalities may influence long-term treatment compliance.
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Affiliation(s)
- Giorgia Rizza
- General Surgery and Liver Transplant Center, S. Giovanni Battista Hospital, Turin I-10126, Italy
| | | | - Masha Eletskaya
- Lumanity Insight (Cello Health Insight), London SE1 1PP, United Kingdom
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Volpes R, Burra P, Germani G, Manini MA, Caccamo L, Strignano P, Rizza G, Tamè M, Pinna AD, Calise F, Migliaccio C, Carrai P, De Simone P, Valentini MF, Lupo LG, Cordone G, Picciotto FP, Nicolucci A. Switch from intravenous or intramuscular to subcutaneous hepatitis B immunoglobulin: effect on quality of life after liver transplantation. Health Qual Life Outcomes 2020; 18:99. [PMID: 32276633 PMCID: PMC7149917 DOI: 10.1186/s12955-020-01349-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2018] [Accepted: 04/02/2020] [Indexed: 01/05/2023] Open
Abstract
BACKGROUND Hepatitis B immunoglobulin (HBIG) therapy is available in intravenous (IV) or intra-muscular (IM) formulations. Recently, a subcutaneous (SC) formulation was introduced. This study evaluated changes in quality of life when liver transplant (LT) recipients were switched from IV or IM HBIG to the SC formulation. METHODS This multicentre, observational study involved adults who had undergone LT at least 1 year prior to study entry. Quality of life was evaluated using the ITaLi-Q questionnaire, assessing the impact of HBIG therapy on daily activities and patient satisfaction, and the SF-36 Health Survey. Patients completed the questionnaires prior to switching from IV or IM HBIG to SC HBIG and 6 months later. RESULTS Eighty-six patients were enrolled; before the switch, 68.6% were receiving IM HBIG and 31.4% IV HBIG. After 6 months, significant improvements in 7 of the 8 ITaLi-Q domains were found, particularly side effects, need for support to adhere to the therapy and satisfaction with the HBIG therapy. Significant improvements in several SF-36 domains were documented, including physical functioning, physical and emotional role limitations, pain, social functioning, physical and mental summary scores. CONCLUSIONS The SC route of administration reduces side effects and their interference with daily life, ameliorates negative feelings, and increases patient autonomy.
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Affiliation(s)
- Riccardo Volpes
- Mediterranean Institute for Transplantation and High Specialization Therapies, Palermo, Italy
| | - Patrizia Burra
- Multivisceral Transplant Unit (Gastroenterology), Department of Surgery, Oncology and Gastroenterology,Surgical and Gastroenterological Sciences, Padua University Hospital, Padua, Italy
| | - Giacomo Germani
- Multivisceral Transplant Unit (Gastroenterology), Department of Surgery, Oncology and Gastroenterology,Surgical and Gastroenterological Sciences, Padua University Hospital, Padua, Italy
| | - Matteo Angelo Manini
- 1st Division of Gastroenterology and Hepatology, Ca' Granda-Maggiore Polyclinic Hospital, Scientific Institute for Research, Hospitalization, and Health Care, Milan, Italy
| | - Lucio Caccamo
- 1st Division of Gastroenterology and Hepatology, Ca' Granda-Maggiore Polyclinic Hospital, Scientific Institute for Research, Hospitalization, and Health Care, Milan, Italy
| | - Paolo Strignano
- General Surgery and Liver Transplant Center, S. Giovanni Battista Hospital, Turin, Italy
| | - Giorgia Rizza
- General Surgery and Liver Transplant Center, S. Giovanni Battista Hospital, Turin, Italy
| | - Mariarosa Tamè
- Liver and Multiorgan Transplantation, Department of General Surgery, Sant'Orsola-Malpighi Polyclinic, Bologna, Italy
| | - Antonio Daniele Pinna
- Liver and Multiorgan Transplantation, Department of General Surgery, Sant'Orsola-Malpighi Polyclinic, Bologna, Italy
| | - Fulvio Calise
- Hepatobiliary Surgery and Transplant Unit, Cardarelli Hospital, Naples, Italy
| | - Carla Migliaccio
- Hepatobiliary Surgery and Transplant Unit, Cardarelli Hospital, Naples, Italy
| | - Paola Carrai
- Department of General Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy
| | - Paolo De Simone
- Department of General Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy
| | - Maria Filippa Valentini
- General Surgery and Liver Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
| | - Luigi Giovanni Lupo
- General Surgery and Liver Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
| | | | | | - Antonio Nicolucci
- Center for Outcomes Research and Clinical Epidemiology, Via Tiziano Vecellio, 2, 65124, Pescara, Italy.
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