Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Transplant. Sep 18, 2024; 14(3): 90949
Published online Sep 18, 2024. doi: 10.5500/wjt.v14.i3.90949
Impact of hepatitis B immunoglobulin mode of administration on treatment experiences of patients after liver transplantation: Results from an online survey
Giorgia Rizza, Kyriaki Glynou, Masha Eletskaya
Giorgia Rizza, General Surgery and Liver Transplant Center, S. Giovanni Battista Hospital, Turin I-10126, Italy
Kyriaki Glynou, Medical Affairs, Biotest AG, Dreieich 63303, Germany
Masha Eletskaya, Lumanity Insight (Cello Health Insight), London SE1 1PP, United Kingdom
Author contributions: Glynou K and Eletskaya M designed the study; Eletskaya M contributed to the study conduct, data acquisition, analysis, and interpretation of results; Rizza G, Glynou K, and Eletskaya M drafted the manuscript; and all authors have read and approved the final manuscript.
Institutional review board statement: This study was conducted within the BHBIA guidelines following the code of conduct of the European Pharmaceutical Market Research Association, European Society for Opinion and Marketing Research, and the Market Research Society. Ethics committee review was not sought for this online patient survey research. In addition, the reporting of the study followed guidance provided by the Consolidated Criteria for Reporting Qualitative Studies. The study conduct adhered with the provisions of the European Union’s General Data Protection Regulation with regard to data protection.
Informed consent statement: Informed consent was obtained electronically from all individual participants included in the study. Participants’ rights and privacy were protected at all times throughout the study. Participants were granted the right to withdraw from the study at any time during the study conduct and to withhold information as they saw fit. All information/data that could identify respondents to third parties was kept strictly confidential; all respondents remained anonymous as their answers were reported in aggregate with the answers of all other participants.
Conflict-of-interest statement: Glynou K is an employee of Biotest AG. Eletskaya M is an employee of Lumanity (previously Cello Health Insight); the study was conducted under a contract with Biotest AG. Rizza G received consulting fees under a contract with Biotest AG. The authors have no non-financial competing interests to declare.
Data sharing statement: An anonymous version of the datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Masha Eletskaya, MSc, Director, Lumanity Insight (Cello Health Insight), Great Suffolk Yard, 2nd Floor, 131 Great Suffolk Street, London SE1 1PP, United Kingdom. masha.eletskaya@lumanity.com
Received: December 18, 2023
Revised: May 2, 2024
Accepted: June 7, 2024
Published online: September 18, 2024
Processing time: 225 Days and 21 Hours
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.

Keywords: Hepatitis B immunoglobulin; Liver transplantation; Subcutaneous; Intramuscular; Intravenous; Patient satisfaction

Core Tip: Hepatitis B immunoglobulin (HBIG) combined with a potent nucleos(t)ide analog is recommended in patients undergoing liver transplantation for hepatitis B virus-associated disease. A survey was conducted to determine patients’ thoughts about three forms of HBIG treatment administration - subcutaneous (SC), intramuscular, and intravenous. Regarding current treatment, SC HBIG had the least negative impact on emotional well-being and social life, was most convenient, easiest to administer and least painful. Considering hypothetical HBIG products, SC was preferred over intramuscular and intravenous for ease of administration, convenience, and pain. For these patients, the most important considerations were ease of use, frequency, duration, and side effects.