Evidence map›Paper›PMID 35534995›Full record

ArticleAnnals of transplantation2022

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.

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

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Annals of transplantation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 9 institutions in 3 countries.

Bruno RocheHepato-Biliary Center, AP-HP Hôpital Universitaire Paul Brousse, Paris-Saclay University, Research INSERM-Paris Saclay Unit 1193, Villejuif, France.
Artur BauhoferCorporate Medical Affairs, Biotest AG, Dreieich, Germany.
Miguel Ãngel Gomez BravoTransplantiaton Unit, Virgen del Rocío University Hospital, Sevilla, Spain.
Georges Philippe PageauxDepartment of Hepato-GastroEnterology Montpellier University Hospital, Montpellier University, Montpellier, France.
Fabien ZoulimHepatology Service, North Hospital Group, Hospices Civils de Lyon; Université Lyon 1; INSERM Unit 1052, Lyon, France.
Alejandra OteroLiver Transplant Unit, University Hospital of A Coruña, Coruña, Spain.
Martin PrietoLiver Transplantation and Hepatology Unit, Hospital Universitari I Politècnic La Fe-IIS La Fe, Valencia, Spain.
Carmen BaliellasLiver Transplant Unit, Bellvitge University Hospital, Barcelona, Spain.
Didier SamuelHepato-Biliary Center, AP-HP Hôpital Universitaire Paul Brousse, Paris-Saclay University, Research INSERM-Paris Saclay Unit 1193, Villejuif, France.
Assistance Publique – Hôpitaux de Paris · FRBellvitge University Hospital · ESBiotest (Germany) · DECentre Hospitalier Universitaire de Montpellier · FRHôpital Paul-Brousse · FRHospices Civils de Lyon · FRHospital Universitari i Politècnic La Fe · ESHospital Universitario Virgen del Rocío · ESUniversidade da Coruña · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Carcinoma, HepatocellularHepatitis BLiver NeoplasmsLiver TransplantationAdultAntiviral AgentsFemaleHumansImmunoglobulinsMaleNeoplasm Recurrence, LocalPatient Reported Outcome MeasuresProspective StudiesQuality of LifeRecurrenceReinfectionAntiviral AgentsImmunoglobulins

Identifiers

PMID35534995
PMCPMC9107284
OpenAlexW4223989147

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.