The efficacy and safety of pegylated interferon α-2b-based immunotherapy for inactive hepatitis B surface antigen carriers.
Humans
Adult
Hepatitis B Surface Antigens
Antiviral Agents
/ adverse effects
Prospective Studies
Hepatitis B, Chronic
/ diagnosis
Interferon-alpha
/ adverse effects
Polyethylene Glycols
/ adverse effects
Immunotherapy
Recombinant Proteins
/ adverse effects
Treatment Outcome
Hepatitis B e Antigens
Hepatitis B virus
Journal
European journal of gastroenterology & hepatology
ISSN: 1473-5687
Titre abrégé: Eur J Gastroenterol Hepatol
Pays: England
ID NLM: 9000874
Informations de publication
Date de publication:
01 10 2023
01 10 2023
Historique:
medline:
5
9
2023
pubmed:
14
8
2023
entrez:
14
8
2023
Statut:
ppublish
Résumé
Pegylated interferon α-2b (PegIFNα-2b) therapy can help inactive hepatitis B surface antigen (HBsAg) carriers (IHCs) achieve clinical cure. To explore and compare the efficacy, safety, and relevant influential factors of PegIFNα-2b monotherapy and PegIFNα-2b-based immunotherapy for IHCs. This exploratory, prospective, single-center, randomized controlled trial enrolled 40 IHCs who were randomized into group A (PegIFNα-2b treatment for 68 weeks) and group B (two cycles of PegIFNα-2b treatment with a lead-in period of GM-CSF and vaccine treatment before each cycle). The primary endpoint was 68-week HBsAg loss rate. At week 68, the HBsAg loss rates were 45.45% [full analysis set (FAS)] and 46.67% [per-protocol set (PPS)]. There was no statistically significant difference in HBsAg loss rate between groups A and B ( P > 0.05). Univariate analysis revealed that age ≤40 years old, baseline HBsAg <200 IU/ml, and 24-week HBsAg decline ≥2 log 10 IU/ml were significantly associated with HBsAg loss in FAS population ( P < 0.05). Multivariate analysis showed that only 24-week HBsAg decline ≥2 log 10 IU/ml was the independent influencing factor in both FAS and PPS populations ( P < 0.05). The adverse events were common and mild, and the therapies were well-tolerated. Treatment of IHCs with PegIFNα-2b-based therapy could result in a high HBsAg loss rate. The HBsAg loss rate of combined immunotherapy was similar to that of PegIFNα-2b monotherapy, and the safety was good. NCT05451420.
Identifiants
pubmed: 37577817
doi: 10.1097/MEG.0000000000002627
pii: 00042737-990000000-00225
doi:
Substances chimiques
Hepatitis B Surface Antigens
0
Antiviral Agents
0
Interferon-alpha
0
Polyethylene Glycols
3WJQ0SDW1A
Recombinant Proteins
0
Hepatitis B e Antigens
0
Banques de données
ClinicalTrials.gov
['NCT05451420']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1216-1223Subventions
Organisme : Xiamen Amoytop Biotech Co., Ltd
Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
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