Evidence map›Paper›PMID 41420154›Full record

ArticleBMC infectious diseases2025

Efficacy and safety of PEG-IFN α-2b and tenofovir amibufenamide in combination therapy for chronic hepatitis B.

Wen Zhao, Longcan Li, Shihui Liu, Wenjie Zhang, Yufeng Gao, Zonghao Zhao, Xiaojun Liu, Yi Luo, Dongdong Li, Chuanmiao Liu

Abstract readMulticenter Study
In one paragraph

Article in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Article
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

10 authors.

Wen Zhao *Department of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Longcan Li *Department of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Shihui LiuDepartment of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Wenjie ZhangDepartment of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Yufeng GaoDepartment of Infectious Diseases, The First Affiliated Hospital of Anhui Medical University, Hefei, 230000, China.
Zonghao ZhaoDepartment of Infectious Diseases, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230001, China.
Xiaojun LiuDepartment of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Yi LuoDepartment of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Dongdong LiDepartment of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China.
Chuanmiao LiuDepartment of Infectious Diseases, The First Affiliated Hospital of Bengbu Medical University, No. 287 Changhuai Road, Bengbu, Anhui Province, 233000, China. Liuchuanmiao119@sina.com.

Funding

2024 Science and Technology Program of Bengbu Medical Collage 2024byzd093Clinical and Translational Research Project of Anhui Province 202304295107020084
6 · The paper itself

Abstract

backgroundThis study aimed to explore the efficacy and safety of combination therapy with PEG-IFN α-2b and tenofovir amibufenamide (TMF) for the treatment of chronic hepatitis B (CHB).

methodsThis multicenter study enrolled 84 CHB patients, who received PEG-IFN α-2b (180 µg/weekly) and TMF (25 mg/day) for 48 weeks. Clinical and laboratory assessments were performed at baseline and at 12-week intervals (weeks 12, 24, 36, and 48). Serologic response (SR) was defined as hepatitis B surface antigen (HBsAg) loss (< 0.05 IU/mL), with or without HBsAg seroconversion (HBsAg < 0.05 IU/mL and HBsAb > 10 mIU/mL). Adverse events (AEs) were monitored at each assessment. Logistic regression and receiver operating characteristic curve analyses were used to identify predictors of HBsAg clearance.

resultsThe combination therapy of PEG-IFN α-2b and TMF resulted in significant reductions in HBsAg levels from baseline at weeks 24, 36, and 48. At these time points, the proportion of patients with undetectable HBV DNA increased progressively, with the proportion reaching 94.7% at week 48. In the SR group, the baseline HBsAg and HBeAg levels were significantly lower than those in the non-serological response (NSR) group, with greater reductions in HBsAg observed at weeks 12 and 24. Multivariate analysis revealed that baseline HBsAg levels and the degree of HBsAg decline at week 24 were independent predictors of HBsAg loss, with odds ratios of 4.609 and 3.237, respectively. The diagnostic performance of baseline HBsAg levels and their decline at week 24 demonstrated areas under the curves (AUCs) of 0.856 and 0.821, respectively, with a combined AUC of 0.908. The cumulative HBsAg clearance rates were 25% in treatment-naïve patients and 26.7% in treatment-experienced patients. The most frequently reported AEs included fever, fatigue, rash, alopecia, elevated ALT and AST levels, neutropenia, and thrombocytopenia.

conclusionsPEG-IFN α-2b and TMF combination therapy effectively reduced HBsAg levels in CHB patients. Baseline HBsAg levels and the magnitude of their decline by week 24 served as robust predictors of serological response, exhibiting high diagnostic value.

Indexed as

Antiviral AgentsHepatitis B, ChronicInterferon-alphaPolyethylene GlycolsTenofovirAdultDNA, ViralDrug Therapy, CombinationFemaleHepatitis B Surface AntigensHepatitis B virusHumansInterferon alpha-2MaleMiddle AgedRecombinant ProteinsAntiviral AgentsDNA, ViralHepatitis B Surface AntigensInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsTenofovirChronic hepatitis BCombination therapyHBsAg clearancePEG-IFN α-2bTenofovir amibufenamide

Identifiers

PMID41420154
PMCPMC12831449

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.