Evidence map›Paper›PMID 39914435›Full record

Trial reportThe lancet. Gastroenterology & hepatology2025

Early antiviral treatment with tenofovir alafenamide to prevent serious clinical adverse events in adults with chronic hepatitis B and moderate or high viraemia (ATTENTION): interim results from a randomised controlled trial.

Young-Suk Lim, Ming-Lung Yu, Jonggi Choi, Chi-Yi Chen, Won-Mook Choi, Wonseok Kang, Gi-Ae Kim, Hyung Joon Kim, Yun Bin Lee, Jeong-Hoon Lee and 17 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The lancet. Gastroenterology & hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. [APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Article
  2. Review
  3. Review
  4. Article
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  6. Novel insights into chronic HBV infection.Nature reviews. Gastroenterology & hepatology · 2026
    Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Progress towards "The Treat-All Approach" for hepatitis B.Translational gastroenterology and hepatology · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Young-Suk LimDepartment of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: limys@amc.seoul.kr.
Ming-Lung YuKaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Jonggi ChoiDepartment of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Chi-Yi ChenDitmanson Medical Foundation Chia-Yi Christian Hospital, Chia-Yi, Taiwan.
Won-Mook ChoiDepartment of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Wonseok KangSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Gi-Ae KimKyung Hee University Hospital, Kyung Hee University, Seoul, South Korea.
Hyung Joon KimChung-Ang University Hospital, Chung-Ang University, Seoul, South Korea.
Yun Bin LeeSeoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
Jeong-Hoon LeeSeoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
Neung Hwa ParkUlsan University Hospital, University of Ulsan College of Medicine, Seoul, South Korea.
So Young KwonKonkuk University Medical Center, Konkuk University, Seoul, South Korea.
Soo Young ParkKyungpook National University Hospital, Kyungpook National University, Daegu, South Korea.
Ji Hoon KimKorea University Guro Hospital, Korea University, Seoul, South Korea.
Gwang Hyeon ChoiSeoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Eun Sun JangSeoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Chien-Hung ChenKaohsiung Chang Gung Memorial Hospital of the Chang Gung Medical Foundation, Kaohsiung, Taiwan.
Yao-Chun HsuE-Da Hospital, Kaohsiung, Taiwan.
Ming-Jong BairTaitung Mackay Memorial Hospital, New Taipei, Taiwan.
Pin-Nan ChengNational Cheng Kung University Hospital, Tainan, Taiwan.
Hung-Da TungChi Mei Hospital, Liouying, Taiwan.
Te-Sheng ChangChang Gung Memorial Hospital, Chia-Yi, Taiwan.
Ching-Chu LoSt Martin De Porres Hospital, Chia-Yi, Taiwan.
Kuo-Chih TsengDalin Tzu Chi Hospital, Chia-Yi, Taiwan.
Sheng-Shun YangTaichung Veterans General Hospital, Taichung, Taiwan.
Cheng-Yuan PengChina Medical University Hospital, Taichung, Taiwan.
Seungbong HanDepartment of Biostatistics, Korea University, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent guidelines for chronic hepatitis B recommend antiviral therapy for individuals with non-cirrhotic chronic hepatitis B only if they have significant liver fibrosis or elevated alanine aminotransferase (ALT) concentrations. We aimed to assess the efficacy of early antiviral treatment in preventing serious liver-related adverse events in individuals with non-cirrhotic chronic hepatitis B and moderate or high viraemia but normal or mildly elevated ALT concentrations.

methodsATTENTION is an ongoing randomised controlled trial being conducted at 22 centres in South Korea and Taiwan. Adults aged 40-80 years with non-cirrhotic chronic hepatitis B and serum hepatitis B virus (HBV) DNA concentrations between 4 log

findingsBetween Feb 8, 2019 and Oct 17, 2023 (the cutoff date for the first interim analysis), 798 individuals were screened and 734 were randomly assigned (369 to tenofovir alafenamide and 365 to observation). At a median follow-up of 17·7 months (IQR 8·3-24·4), the primary endpoint occurred in 11 participants: two in the tenofovir alafenamide group (both hepatocellular carcinoma) and nine in the observation group (seven hepatocellular carcinoma, one hepatic decompensation, and one death), corresponding to an incidence rate of 0·33 per 100 person-years in the tenofovir alafenamide group and 1·57 per 100 person-years in the observation group (hazard ratio 0·21 [97·5% CI 0·04-1·20]; p=0·027). The difference between the two groups did not surpass the prespecified boundaries required to stop the trial early. Serious adverse events, excluding primary endpoints, were reported in 23 (6%) participants in the tenofovir alafenamide group and 24 (7%) in the observation group.

interpretationThe results of this interim analysis suggest that early treatment with tenofovir alafenamide reduces the risk of liver-related serious adverse events compared with observation in adults with non-cirrhotic chronic hepatitis B and moderate or high viraemia but normal or mildly elevated ALT concentrations. Although these findings await confirmation in planned future analyses, they suggest that existing guidelines could be expanded to allow early antiviral therapy in patients with a moderate or high HBV viral load, irrespective of ALT concentrations.

fundingGovernment of South Korea and Gilead Sciences.

Indexed as

AdenineAntiviral AgentsHepatitis B, ChronicTenofovirViremiaAdultAgedAged, 80 and overAlanineAlanine TransaminaseCarcinoma, HepatocellularDNA, ViralFemaleHepatitis B virusHumansLiver NeoplasmsAdenineAlanineAlanine TransaminaseAntiviral AgentsDNA, ViralTenofovirtenofovir alafenamide

Identifiers

PMID39914435

What Socratic holds

Textmetadata
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 Socratic graph.