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.
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Identifiers
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
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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
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