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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.
Roche, Bruno; Bauhofer, Artur; Gomez Bravo, Miguel Ãngel; Pageaux, Georges Philippe; Zoulim, Fabien; Otero, Alejandra; Prieto, Martin; Baliellas, Carmen; Samuel, Didier.
Afiliación
  • Roche B; Hepato-Biliary Center, AP-HP Hôpital Universitaire Paul Brousse, Paris-Saclay University, Research INSERM-Paris Saclay Unit 1193, Villejuif, France.
  • Bauhofer A; Corporate Medical Affairs, Biotest AG, Dreieich, Germany.
  • Gomez Bravo MÃ; Transplantiaton Unit, Virgen del Rocío University Hospital, Sevilla, Spain.
  • Pageaux GP; Department of Hepato-GastroEnterology Montpellier University Hospital, Montpellier University, Montpellier, France.
  • Zoulim F; Hepatology Service, North Hospital Group, Hospices Civils de Lyon; Université Lyon 1; INSERM Unit 1052, Lyon, France.
  • Otero A; Liver Transplant Unit, University Hospital of A Coruña, Coruña, Spain.
  • Prieto M; Liver Transplantation and Hepatology Unit, Hospital Universitari I Politècnic La Fe-IIS La Fe, Valencia, Spain.
  • Baliellas C; CIBERehd, Instituto de Salud Carlos III, Madrid, Spain.
  • Samuel D; Liver Transplant Unit, Bellvitge University Hospital, Barcelona, Spain.
Ann Transplant ; 27: e936162, 2022 May 10.
Article en En | MEDLINE | ID: mdl-35534995
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante de Hígado / Carcinoma Hepatocelular / Hepatitis B / Neoplasias Hepáticas Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies Aspecto: Patient_preference Límite: Adult / Female / Humans / Male Idioma: En Revista: Ann Transplant Asunto de la revista: TRANSPLANTE Año: 2022 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante de Hígado / Carcinoma Hepatocelular / Hepatitis B / Neoplasias Hepáticas Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies Aspecto: Patient_preference Límite: Adult / Female / Humans / Male Idioma: En Revista: Ann Transplant Asunto de la revista: TRANSPLANTE Año: 2022 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Estados Unidos