Evidence map›Paper›PMID 34930140›Full record

Trial reportBMC gastroenterology2021

Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study.

Fumitaka Suzuki, Yoshiyuki Suzuki, Yoshiyasu Karino, Yasuhito Tanaka, Masayuki Kurosaki, Hiroshi Yatsuhashi, Tomofumi Atarashi, Masanori Atsukawa, Tsunamasa Watanabe, Masaru Enomoto and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03258710 (A Multi-centre, One-arm Prospective Study to Evaluate Efficacy and Safety of Switching From Entecavir), 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
0.2field-weighted citation impact, top 45% 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.

NCT03258710 phase4completednot on this map

A Multi-centre, One-arm Prospective Study to Evaluate Efficacy and Safety of Switching From Entecavir (ETV) to Tenofovir Disoproxil Fumarate (TDF) in Japanese Chronic Hepatitis B HBeAg-positive and HBV-DNA Undetectable Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2019Enrolled75ConditionsHepatitis B, ChronicArmsTenofovir Disoproxil Fumarate
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

26 authors at 20 institutions in 1 country.

Fumitaka SuzukiToranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki-city, Kanagawa, 213-8587, Japan.
Yoshiyuki SuzukiToranomon Hospital, 2-2-2, Toranomon, Minato-ku, 105-8470, Japan.
Yoshiyasu KarinoSapporo-Kosei General Hospital, 8-5, Kita 3-jo Higashi, Chuo-ku, Sapporo-city, Hokkaido, 060-0033, Japan.
Yasuhito TanakaNagoya City University Hospital, 1, Aza-Kawasumi, Mizuho, Nagoya, Aichi, 467-8602, Japan.
Masayuki KurosakiMusashino Red Cross Hospital, 1-26-1, Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan.
Hiroshi YatsuhashiNational Hospital Organization Nagasaki Medical Center, 2-1001-1, Kubara, Omura-city, Nagasaki, 856-8562, Japan.
Tomofumi AtarashiObihiro-Kosei General Hospital, 10-1, Nishi 14-jo Minami, Obihiro-city, Hokkaido, 080-0024, Japan.
Masanori AtsukawaNippon Medical School Chiba Hokusoh Hospital, 1715, Kamakari, Inzai-City, Chiba, 270-1694, Japan.
Tsunamasa WatanabeSt. Marianna University School of Medicine Hospital, 2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, 216-8511, Japan.
Masaru EnomotoOsaka City University Hospital, 1-5-7, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8586, Japan.
Masatoshi KudoKindai University Hospital, 377-2, Ohnohigashi, Osakasayama-city, Osaka, 589-8511, Japan.
Naoto MaedaSanin Rosai Hospital, 1-8-1, Kaikeshinden, Yonago-city, Tottori, 683-8605, Japan.
Hiroshi KohnoNational Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure-city, Hiroshima, 737-0023, Japan.
Kouji JokoMatsuyama Red Cross Hospital, 1, Bunkyo-cho, Matsuyama-city, Ehime, 790-8524, Japan.
Kojiro MichitakaEhime Prefectural Central Hospital, 83, Kasugamachi, Matsuyama-city, Ehime, 790-0024, Japan.
Koichiro MikiKitakyushu City Hospital Organization Kitakyushu Municipal Medical Center, 2-1-1, Bashaku, Kokurakita-ku, Kitakyushu-city, Fukuoka, 802-0077, Japan.
Kazuhiro TakahashiHamanomachi Hospital, 3-3-1, Nagahama, Chuo-ku, Fukuoka-city, Fukuoka, 810-8539, Japan.
Tatsuya IdeKurume University Hospital, 67, Asahi-machi, Kurume-shi, Fukuoka, 830-0011, Japan.
Shigetoshi FujiyamaKumamoto Shinto General Hospital, 3-2-65, Ooe, Chuo-ku, Kumamoto-city, Kumamoto, 862-8655, Japan.
Tomoko KohnoGlaxoSmithKline K.K., Akasaka Intercity AIR, 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
Hiroshi ItohGlaxoSmithKline K.K., Akasaka Intercity AIR, 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
Sakiyo TsukamotoGlaxoSmithKline K.K., Akasaka Intercity AIR, 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
Yuko SuzukiGlaxoSmithKline K.K., Akasaka Intercity AIR, 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
Yoshiaki KawanoGlaxoSmithKline K.K., Akasaka Intercity AIR, 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan. yoshiaki.x.kawano@gsk.com.ORCID http://orcid.org/0000-0002-2305-1711
Wataru SugiuraNational Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, 162-8655, Japan.
Hiromitsu KumadaToranomon Hospital, 2-2-2, Toranomon, Minato-ku, 105-8470, Japan.
GlaxoSmithKline (Japan) · JPToranomon Hospital · JPChiba Hokusou Hospital · JPEhime Prefectural Central Hospital · JPHamanomachi Hospital · JPKindai University Hospital · JPKitakyushu Municipal Medical Center · JPKumamoto City Hospital · JPKurume University Hospital · JPMatsuyama Red Cross Hospital · JPMusashino Red Cross Hospital · JPNagasaki Medical Center · JPNagoya City University Hospital · JPNational Center for Global Health and Medicine · JPNational Hospital Organization · JPObihiro Kosei General Hospital · JPOsaka City University Hospital · JPSanin Rosai Hospital · JPSapporo Kosei General Hospital · JPSt. Marianna University School of Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTenofovir disoproxil fumarate (TDF) is widely used and recommended as first-line treatment for patients infected with the hepatitis B virus (HBV). However, current data are limited regarding the efficacy and safety of switching to TDF for the treatment of chronic hepatitis B in hepatitis B e-antigen (HBeAg)-positive patients who are virologically suppressed with another nucleos(t)ide analogue. The primary objective of this study was to evaluate the hepatitis B surface antigen (HBsAg) reduction potential of switching from entecavir (ETV) to TDF at week 48 in HBeAg-positive chronic hepatitis B patients with undetectable serum HBV-DNA.

methodsIn this multicenter, single-arm, open-label, phase 4 clinical study, 75 participants currently treated with ETV 0.5 mg once daily were switched to TDF 300 mg once daily for 96 weeks.

resultsAt week 48, 3/74 participants (4%) achieved 0.25 log

conclusionsIn conclusion, HBsAg reduction was limited after switching from ETV to TDF in this study population. Further investigation is warranted to better understand the clinical impact of switching from ETV to TDF. ClinicalTrials.gov: NCT03258710 registered August 21, 2017. https://clinicaltrials.gov/ct2/show/NCT03258710?term=NCT03258710&draw=2&rank=1.

Indexed as

Hepatitis B, ChronicHepatitis B e AntigensGuanineHumansProspective StudiesTenofovirentecavirGuanineHepatitis B e AntigensTenofovirChronic hepatitis BEntecavirHBeAg-positiveHBsAgTenofovir disoproxil fumarate

Identifiers

PMID34930140
PMCPMC8686386
OpenAlexW4200348393

What OpenQuestion holds

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LicenceCC BY
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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.