Evidence map›Paper›PMID 42015653›Full record

Trial reportGut and liver2026

Efficacy and Safety of Switching from Entecavir to Tenofovir Alafenamide in Chronic Hepatitis B: A Multicenter Randomized Trial in Korea.

Hyunjae Shin, Moon Haeng Hur, Yang Hyun Baek, Chun Kyon Lee, Yong Kyun Cho, June Sung Lee, Jae Yoon Jeong, Yong Jin Jung, Ja Kyung Kim, Moon Young Kim and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IVEquivalence TrialMulticenter Study
In one paragraph

Trial report in Gut and liver, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06000657 (Efficacy and Safety of Switching to Vemliver), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06000657 phase4completednot on this map

Efficacy and Safety of Switching to Vemliver (Tenofovir Alafenamide) From Entecavir in Chronic Hepatitis B: A Multi-Center, Phase IV, Open-Label, Randomized, Active-Controlled, Non-Inferiority Trial.

TypeinterventionalSponsorDaewoong Pharmaceutical Co. LTD.Ran2023 to 2025Enrolled196ConditionsHepatitis B, ChronicArmsVemliver tablet, Baracross Tablet
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Hyunjae ShinDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0003-1023-8795
Moon Haeng HurDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0001-5463-6782
Yang Hyun BaekDepartment of Internal Medicine, Dong-A University Hospital, Busan, Korea.ORCID 0000-0002-9073-9233
Chun Kyon LeeDepartment of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.ORCID 0000-0002-8492-2883
Yong Kyun ChoDepartment of Gastroenterology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0003-3781-3665
June Sung LeeDepartment of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.ORCID 0000-0002-1803-9398
Jae Yoon JeongDepartment of Internal Medicine, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.ORCID 0000-0002-3624-3261
Yong Jin JungDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0001-8785-2254
Ja Kyung KimDepartment of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea.ORCID 0000-0001-5025-6846
Moon Young KimDepartment of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.ORCID 0000-0002-2501-2206
Yeon Seok SeoDepartment of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.ORCID 0000-0003-4171-6331
Woo Jin ChungDepartment of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea.ORCID 0000-0002-3736-1067
Moon Soo KohDepartment of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.ORCID 0000-0002-3534-8459
Jeong-Han KimDepartment of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.ORCID 0000-0002-8383-8524
Yun Bin LeeDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0002-3193-9745
Eun Ju ChoDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0002-2677-3189
Jeong-Hoon LeeDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0002-0315-2080
Su Jong YuDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0001-8888-7977
Jung-Hwan YoonDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0002-9128-3610
Yoon Jun KimDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0001-9141-7773

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background/Aims: Tenofovir alafenamide (TAF) has emerged as a safe and effective alternative to entecavir (ETV) in the management of chronic hepatitis B (CHB). We aimed to evaluate the efficacy and safety of switching to TAF compared with maintaining ETV in patients with CHB who had achieved virologic suppression on ETV. Methods: In this multicenter, randomized, open-label, active-controlled, noninferiority clinical trial conducted at 13 Korean centers, 196 CHB patients who had experienced virologic suppression after ≥24 weeks of ETV therapy were randomized 1:1 to switch to TAF (n=95) or continue on ETV (n=101). The primary endpoint was the proportion of patients with hepatitis B virus (HBV) DNA <29 IU/mL at week 48 (per-protocol set). Secondary endpoints included alanine aminotransferase (ALT) normalization, hepatitis B surface antigen and hepatitis B e antigen serologic responses, and safety outcomes. Results: Among 188 patients in the per-protocol set (89 TAF, 99 ETV), the HBV suppression rate at week 48 was 100.0% in the TAF group and 99.0% in the ETV group (difference, 1.03%; one-sided 97.5% confidence interval, -0.96 to infinity). ALT normalization rates at week 48 were comparable between groups (55.0% in TAF vs 38.7% in ETV; p=0.26; American Association for the Study of Liver Diseases criteria). Hepatitis B e antigen seroconversion rates were also similar at week 48 (0.0% vs 12.5%; p=0.21). Safety profiles, including renal function, did not significantly differ between the two groups. Conclusions: Switching from ETV to TAF was noninferior to continuing ETV in maintaining virologic suppression, with comparable biochemical, serologic, and safety outcomes. (ClinicalTrials. gov identifier NCT06000657).

Indexed as

Antiviral AgentsDrug SubstitutionGuanineHepatitis B, ChronicTenofovirAdultAlanineAlanine TransaminaseDNA, ViralFemaleHepatitis B e AntigensHepatitis B virusHumansMaleMiddle AgedRepublic of KoreaAlanineAlanine TransaminaseAntiviral AgentsDNA, ViralentecavirGuanineHepatitis B e AntigensTenofovirtenofovir alafenamideCholesterolChronic hepatitis BEntecavirHepatitis B virusTenofovir alafenamide

Identifiers

PMID42015653
PMCPMC13364756

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Registered trials

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.