dc.creator | Roche, Bruno | es |
dc.creator | Bauhofer, Artur | es |
dc.creator | Gómez Bravo, Miguel Ángel | es |
dc.creator | Pageaux, Georges Philippe | es |
dc.creator | Zoulim, Fabien | es |
dc.creator | Otero, Alejandra | es |
dc.creator | Prieto, Martin | es |
dc.creator | Baliellas, Carmen | es |
dc.creator | Samuel, Didier | es |
dc.date.accessioned | 2023-05-26T13:56:50Z | |
dc.date.available | 2023-05-26T13:56:50Z | |
dc.date.issued | 2022-05-10 | |
dc.identifier.citation | Roche, B., Bauhofer, A., Gómez Bravo, M.Á., Pageaux, G.P., Zoulim, F., Otero, A.,...,Samuel, D. (2022). Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study. Annals of Transplantation, 27, e936162. https://doi.org/10.12659/AOT.936162. | |
dc.identifier.issn | 1425-9524 | es |
dc.identifier.uri | https://hdl.handle.net/11441/146691 | |
dc.description.abstract | Background: Self-administered subcutaneous hepatitis B immunoglobulin (s.c. HBIg) in combination with nucleos(t)ide analogs (NUCs) has proved to be effective and safe in preventing hepatitis B virus (HBV) reinfection after liver transplantation.
Material and methods: This non-interventional, prospective, single-arm, multicenter, international study collected data on long-term effectiveness, safety, patient satisfaction (Treatment Satisfaction Questionnaire for Medication, TSQM-11), and quality of life (EQ-5D questionnaire) in routine practice over a 2-year treatment period. Data analysis was based on 195 adults (82.1% male) transplanted for HBV-related liver diseases and treated with s.c. HBIg with/without NUC(s).
Results: HBV recurrence (seropositivity of HBV surface antigen and/or HBV DNA) was observed in 7/195 (3.6%) patients (annual rate: 2.01%). Hepatocellular carcinoma (HCC) recurred in 4/83 (4.8%) patients transplanted for HBV-HCC (annual rate: 2.88%). Twenty-nine adverse drug reactions occurred in 16/195 (8.2%) patients. Convenience and overall satisfaction scores of the TSQM-11 were significantly (P<0.05) improved under treatment at the 3-month, 2-year, and last follow-up visits. Quality of life remained constant over the entire observation period (EQ-5D index [P≥0.075]). S.c. HBIg was mainly self-administered (6458/9021 administrations, 71.6%) at home (8514/9021 administrations, 94.4%).
Conclusions: The results indicate long-term effectiveness and safety of s.c. HBIg in combination with NUC therapy in preventing post-transplant HBV reinfection under real-life conditions. The convenience of the therapy contributed to the high overall treatment satisfaction and acceptance by the patients. | es |
dc.format | application/pdf | es |
dc.format.extent | 12 p. | es |
dc.language.iso | eng | es |
dc.relation.ispartof | Annals of Transplantation, 27, e936162. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Carcinoma | es |
dc.subject | Hepatocellular | es |
dc.subject | Hepatitis B Antibodies | es |
dc.subject | Hepatitis B virus | es |
dc.subject | Liver Transplantation | es |
dc.subject | Recurrence | es |
dc.title | Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Cirugía | es |
dc.relation.publisherversion | https://annalsoftransplantation.com/abstract/full/idArt/936162 | es |
dc.identifier.doi | 10.12659/AOT.936162 | es |
dc.journaltitle | Annals of Transplantation | es |
dc.publication.volumen | 27 | es |
dc.publication.initialPage | e936162 | es |