Evidence map›Paper›PMID 32460460›Full record

Trial reportClinical and molecular hepatology2020

Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response.

Hyun Young Woo, Jun Yong Park, Si Hyun Bae, Chang Wook Kim, Jae Young Jang, Won Young Tak, Dong Joon Kim, In Hee Kim, Jeong Heo, Sang Hoon Ahn

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and molecular hepatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01597934 (A Randomized, Multicenter, Prospective Study to Compare Antiviral Efficacy and Safety of Switching to ETV Plus TDF Versus Maintaining LAM/LDT Plus ADF Combination in CHC With PVR to LAM/LDF Plus ADF Combination Rescue Therapy for YMDD Mutation), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT01597934 phase4unknown statusnot on this map

A Randomized, Multicenter, Prospective Study to Compare Antiviral Efficacy and Safety of Switching to ETV Plus TDF Versus Maintaining LAM/LDT Plus ADF Combination in CHC With PVR to LAM/LDF Plus ADF Combination Rescue Therapy for YMDD Mutation

TypeinterventionalSponsorYonsei UniversityRan2012 to 2014Enrolled104ConditionsChronic Hepatitis BArmsGroup A (Zeffix, Sebivo, Hepsera), Group B (Baraclude, Viread)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Viral oncogenesis in cancer: from mechanisms to therapeutics.Signal transduction and targeted therapy · 2025
    Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

Hyun Young WooDepartment of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.
Jun Yong ParkDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Si Hyun BaeDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Chang Wook KimDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Jae Young JangDepartment of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Korea.
Won Young TakDepartment of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
Dong Joon KimDepartment of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
In Hee KimDepartment of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Chonju, Korea.
Jeong HeoDepartment of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.
Sang Hoon AhnDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Catholic University of Korea · KRYonsei University · KRHallym University · KRJeonbuk National University Hospital · KRKyungpook National University · KRPusan National University · KRPusan National University Hospital · KRSoonchunhyang University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsSuboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV.

methodsThis prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded.

resultsCompared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events.

conclusionETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934).

Indexed as

AdenineAdultAntiviral AgentsDNA, ViralDrug Administration ScheduleDrug Resistance, ViralDrug Therapy, CombinationFemaleGuanineHepatitis B, ChronicHepatitis B virusHumansLamivudineMaleMiddle AgedOrganophosphonatesadefovirAdenineAntiviral AgentsDNA, ViralentecavirGuanineLamivudineOrganophosphonatesTelbivudineTenofovirAdefovirAntiviral drug resistanceEntecavirLamivudineTenofovir

Identifiers

PMID32460460
PMCPMC7364362
OpenAlexW3030657114

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.