Publication:
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.

Loading...
Thumbnail Image

Date

2022-05-10

Authors

Roche, Bruno
Bauhofer, Artur
Gomez Bravo, Miguel Ãngel
Pageaux, Georges Philippe
Zoulim, Fabien
Otero, Alejandra
Prieto, Martin
Baliellas, Carmen
Samuel, Didier

Advisors

Journal Title

Journal ISSN

Volume Title

Publisher

Metrics
Google Scholar
Export

Research Projects

Organizational Units

Journal Issue

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

Description

MeSH Terms

Adult
Antiviral Agents
Carcinoma, Hepatocellular
Female
Hepatitis B
Humans
Immunoglobulins
Liver Neoplasms
Liver Transplantation
Male
Neoplasm Recurrence, Local
Patient Reported Outcome Measures
Prospective Studies
Quality of Life
Recurrence
Reinfection
Treatment Outcome

DeCS Terms

CIE Terms

Keywords

Citation