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.

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.

• Authors: Bruno Roche, Artur Bauhofer, Miguel Ãngel Gomez Bravo, Georges Philippe Pageaux, Fabien Zoulim, Alejandra Otero, Martin Prieto, Carmen Baliellas, Didier Samuel
• Journal: Annals of transplantation (Ann Transplant) Vol. 27 Pg. e936162 (May 10 2022) ISSN: 2329-0358 [Electronic] United States
• PMID: 35534995 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Antiviral Agents
• Immunoglobulins

Topics

• Adult
• Antiviral Agents (adverse effects, therapeutic use)
• Carcinoma, Hepatocellular (etiology)
• Female
• Hepatitis B (drug therapy, prevention & control)
• Humans
• Immunoglobulins (therapeutic use)
• Liver Neoplasms (etiology)
• Liver Transplantation (adverse effects)
• Male
• Neoplasm Recurrence, Local (etiology)
• Patient Reported Outcome Measures
• Prospective Studies
• Quality of Life
• Recurrence
• Reinfection
• Treatment Outcome