Evidence map›Paper›PMID 30464407›Full record

Trial reportDrug design, development and therapy2018

Concomitant food intake does not affect the efficacy of entecavir in chronic hepatitis B patients with virological response: a randomized, multicenter, noninferiority trial.

Eun Ju Cho, Su Jong Yu, So Young Kwon, Ji-Hoon Kim, Do Young Kim, Won Kim, June Sung Lee, Jin Woo Lee, Youn Jae Lee, Hee Bok Chae and 1 more

Open access · goldAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the 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, top 83% 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.

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

0 citing papers in PubMed, 1 citations in OpenAlex.

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

11 authors at 7 institutions in 2 countries.

Eun Ju ChoDepartment of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea, ydoctor2@hanmail.net.
Su Jong YuDepartment of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea, ydoctor2@hanmail.net.
So Young KwonDepartment of Internal Medicine, Konkuk University School of Medicine, KonKuk University Hospital, Seoul, South Korea.
Ji-Hoon KimDepartment of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea.
Do Young KimDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Won KimDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea.
June Sung LeeDepartment of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea.
Jin Woo LeeDepartment of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
Youn Jae LeeDepartment of Gastroenterology, Inje University Busan Paik Hospital, Busan, South Korea.
Hee Bok ChaeDepartment of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
Jung-Hwan YoonDepartment of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea, ydoctor2@hanmail.net.
Seoul National University · KRInha University · KRChungbuk National University Hospital · KRInje University Busan Paik Hospital · KRKonkuk University · KRKorea University Medical Center · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLittle clinical data are available about the effect of food on the antiviral efficacy of entecavir for chronic hepatitis B virus (HBV) infection. The present study evaluated whether entecavir administration in the fed state had comparable efficacy to the fasted condition for maintenance of viral suppression in HBV-infected patients with virological response on entecavir therapy.

methodsIn this multicenter, randomized, open-label, noninferiority study, patients who were currently receiving entecavir and showed a serum HBV DNA level of <20 IU/mL were randomized to take entecavir either under the fasted or fed condition for 48 weeks.

resultsWe randomly assigned 50 patients to the fasted group and 46 patients to the fed group. The full analysis set consisted of 49 patients in the fasted group and 44 patients in the fed group. At week 48, the proportion of patients with HBV DNA <20 IU/mL was not significantly different between the fasted and fed groups (98% vs 100%,

conclusionIn patients with virological response under entecavir therapy, concomitant food intake did not affect the antiviral efficacy. For patients with adherence problem, taking entecavir with food may be considered to improve compliance.

Indexed as

EatingAdultAgedAntiviral AgentsFemaleGuanineHepatitis B, ChronicHepatitis B virusHumansMaleMiddle AgedRepublic of KoreaYoung AdultAntiviral AgentsentecavirGuaninechronic hepatitis Befficacyentecavirfood effect

Identifiers

PMID30464407
PMCPMC6223329
OpenAlexW2899200054

What OpenQuestion holds

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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.