Evidence map›Paper›PMID 38376651›Full record

Trial reportHepatology international2024

Preventing viral relapse with prophylactic tenofovir in hepatitis B carriers receiving chemotherapy: a phase IV randomized study in Taiwan.

Chao-Wei Hsu, Shin-Cheh Chen, Po-Nan Wang, Hung-Ming Wang, Yi-Cheng Chen, Chau-Ting Yeh

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IV
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02081469 (Phase IV; Different Extend Treatment Duration), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT02081469 phase4completednot on this map

Phase IV; Different Extend Treatment Duration (6 Months vs 12 Months After Chemotherapy) to Prevent HBV Relapse With Tenofovir for Prophylaxis in Patients With Malignant Tumor Combined With HBV Carrier Receiving Chemotherapy

TypeinterventionalSponsorChang Gung Memorial HospitalRan2014 to 2019Enrolled100ConditionsHepatitis B, Chronic, TumorArmsTDF
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

6 authors at 1 institution in 1 country.

Chao-Wei HsuLiver Research Center, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan. hsu2406@adm.cgmh.org.tw.ORCID http://orcid.org/0000-0003-2454-7193
Shin-Cheh ChenDepartment of General Surgeon, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Po-Nan WangDepartment of Hemato-Oncology, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Hung-Ming WangDepartment of Oncology, Chang Gung Memorial Hospital, Gung University College of Medicine, Taipei, Taiwan.
Yi-Cheng ChenLiver Research Center, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Chau-Ting YehLiver Research Center, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Chang Gung University · TW

Funding

Gilead Sciences IN-US-174-0207
6 · The paper itself

Abstract

BACKGROUND AND

aimsThis study aimed to compare the efficacy of shorter vs. longer tenofovir disoproxil fumarate (TDF) prophylaxis in preventing hepatitis B virus (HBV) relapse in cancer patients with chronic hepatitis B (CHB) undergoing chemotherapy.

methodsThis phase IV, prospective randomized trial enrolled cancer patients with CHB from 2014 to 2019 in Taiwan. Included patients were randomized to receive either 24- (Arm A) or 48-week (Arm B) post-chemotherapy TDF and compared for cumulative incidence of virological and clinical relapse. Logistic regressions were conducted to determine the factors associated with HBV relapse.

resultsOne hundred patients were randomized, and 41 patients in Arm A and 46 in Arm B completed the TDF treatment. No significant difference was found in cumulative incidence of virological relapse (Arm A: 94.4%, Arm B: 93.1%, p = 0.110) or clinical relapse among patients with baseline HBV DNA > 2000 IU/mL (Arm A: 38.9%, Arm B: 26.7%, p = 0.420) between the two arms. High baseline HBV DNA ≥ 10,000 IU/mL (OR = 51.22) and HBsAg ≥ 1000 IU/mL (OR = 8.64) were independently associated with an increased virological relapse. Alanine aminotransferase (ALT), serum phosphorus, vitamin D, and estimated glomerular filtration rate (eGFR) remained stable throughout the study.

conclusionsThe 24-week preventative TDF has comparable efficacy to the 48-week treatment in virologic and clinical relapse. High baseline HBsAg or HBV DNA is associated with a higher risk of HBV relapse. These findings imply a 24-week duration of TDF treatment with a close monitor for patients with a high baseline viral load. Hepatitis B virus infection is a prominent cause of liver cancer and chronic liver disease and affected millions of people worldwide. When HBV-infected people are exposed to immunosuppressive medication or chemotherapy for cancer, the chance of HBV reactivation rises considerably. This trial showed 24-week tenofovir disoproxil fumarate (TDF) may be sufficient for preventing HBV relapse in cancer patients receiving chemotherapy. CLINICAL TRIAL REGISTRATION NUMBER: NCT02081469.

Indexed as

Hepatitis BHepatitis B, ChronicAntiviral AgentsDNA, ViralHepatitis B Surface AntigensHepatitis B virusHumansNeoplasm Recurrence, LocalProspective StudiesTaiwanTenofovirTreatment OutcomeViral LoadAntiviral AgentsDNA, ViralHepatitis B Surface AntigensTenofovirCancerChronic hepatitis B (CHB)Extended tenofovir disoproxil fumarate (TDF) treatmentHepatitis B virus (HBV) reactivationProphylaxis

Identifiers

PMID38376651
OpenAlexW4391969151

What Socratic holds

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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 Socratic graph.