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

Fecha de publicación: 10/05/2022 Fecha Ahead of Print: 10/05/2022

Autores de IIS La Fe

Martín Prieto Castillo

Autor

Participantes ajenos a IIS La Fe

Roche B
Bauhofer A
Bravo, Miguel Angel Gomez
Pageaux GP
Zoulim F
Otero A
Baliellas C
Samuel D

Grupos

Hepatología, Cirugia Hepatobiliopancreática y Trasplantes

Leader

Marina Berenguer Haym

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.

Datos de la publicación

ISSN/ISSNe:: 1425-9524, 2329-0358
Tipo:: Article
Páginas:: -
DOI:: 10.12659/AOT.936162
Factor de Impacto:: 0,429 SCImago ℠
Cuartil:: Q2 SCImago ℠

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Filiaciones

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
Pageaux GP:: Department of Hepato-GastroEnterology Montpellier University Hospital, Montpellier University, Montpellier, France
Zoulim F:: INSERM Unit 1052, Lyon, France
Otero A:: Liver Transplant Unit, University Hospital of A Coruña, Coruña, Spain
Prieto M:: Instituto de Investigación. Liver Transplantation and Hepatology Unit, Hospital Universitari I Politècnic La Fe-IIS La Fe, Valencia, Spain

CIBERehd, Instituto de Salud Carlos III, Madrid, Spain
Baliellas C:: Liver Transplant Unit, Bellvitge University Hospital, Barcelona, Spain
Samuel D:: Hepato-Biliary Center, AP-HP Hôpital Universitaire Paul Brousse, Paris-Saclay University, Research INSERM-Paris Saclay Unit 1193, Villejuif, France