Evidence map›Paper›PMID 30848363›Full record

ArticleJournal of gastroenterology2019

Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan.

Koichi Takaguchi, Hidenori Toyoda, Akemi Tsutsui, Yoshiyuki Suzuki, Makoto Nakamuta, Michio Imamura, Tomonori Senoh, Takuya Nagano, Toshifumi Tada, Yoshihiko Tachi and 13 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
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

23 authors at 15 institutions in 1 country.

Koichi TakaguchiDepartment of Hepatology, Kagawa Prefectural Central Hospital, 1-2-1 Asahi-machi, Takamatsu, Kagawa, 760-8557, Japan. k.takaguchi@chp-kagawa.jp.ORCID http://orcid.org/0000-0003-0175-8721
Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
Akemi TsutsuiDepartment of Hepatology, Kagawa Prefectural Central Hospital, 1-2-1 Asahi-machi, Takamatsu, Kagawa, 760-8557, Japan.
Yoshiyuki SuzukiDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Makoto NakamutaNational Hospital Organization, Kyushu Medical Center, Fukuoka, Japan.
Michio ImamuraDepartment of Gastroenterology and Metabolism, Institute of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.
Tomonori SenohDepartment of Hepatology, Kagawa Prefectural Central Hospital, 1-2-1 Asahi-machi, Takamatsu, Kagawa, 760-8557, Japan.
Takuya NaganoDepartment of Hepatology, Kagawa Prefectural Central Hospital, 1-2-1 Asahi-machi, Takamatsu, Kagawa, 760-8557, Japan.
Toshifumi TadaDepartment of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
Yoshihiko TachiDepartment of Gastroenterology, Komaki City Hospital, Komaki, Japan.
Atsushi HiraokaGastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Kojiro MichitakaGastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Hiroshi ShibataDepartment of Gastroenterology, Tokushima Prefectural Central Hospital, Tokushima, Japan.
Kouji JokoCenter for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Hironao OkuboDepartment of Gastroenterology, Juntendo University Nerima Hospital, Tokyo, Japan.
Kunihiko TsujiCenter of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.
Shintaro TakakiDepartment of Gastroenterology, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Tsunamasa WatanabeDepartment of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Chikara OgawaDepartment of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
Kazuaki ChayamaDepartment of Gastroenterology and Metabolism, Institute of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.
Takashi KumadaDepartment of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan.
Hiromitsu KumadaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Kagawa Prefectural Central Hospital · JPOgaki Municipal Hospital · JPEhime Prefectural Central Hospital · JPHiroshima University · JPToranomon Hospital · JPHiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital · JPJuntendo University Nerima Hospital · JPKindai University · JPKomaki City Hospital · JPMatsuyama Red Cross Hospital · JPNational Kyushu Medical Center · JPSt. Marianna University School of Medicine · JPTakamatsu Red Cross Hospital · JPTeine Keijinkai Hospital · JPTokushima Prefectural Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe virological efficacy and safety of the direct-acting antiviral (DAA) regimen consisting of daclatasvir, asunaprevir, and beclabuvir (DCV/ASV/BCV) for patients chronically infected with hepatitis C virus (HCV) genotype 1 have not been previously evaluated in Japanese real-world settings.

methodsIn a Japanese nationwide multicenter study, the rate of sustained virologic response (SVR) and safety were analyzed in 91 patients who started the DCV/ASV/BCV regimen between November 2016 and July 2017. SVR rates were compared based on baseline patient characteristics.

resultsMore than 60% of patients had a history of failure to achieve SVR with interferon (IFN)-free DAA therapy. Overall, 50 of 91 patients (54.9%) achieved SVR. Multivariate analysis identified a history of failure with IFN-free DAA therapy and pretreatment HCV RNA levels as factors significantly associated with treatment failure. Whereas the SVR rate in patients without a history of IFN-free DAA therapy was 91.7% (33 of 36 patients), it was only 30.9% (17 of 55 patients) among patients with a history of IFN-free DAA therapy. The rate of discontinuation due to an adverse event was 4.4%.

conclusionsMany patients treated with the DCV/ASV/BCV regimen have a history of a failure to achieve SVR with previous IFN-free DAA therapy. SVR rate was not as high as that in pre-approval clinical trial of this regimen in IFN-free DAA-naïve patients. In addition, most patients with a history of failure with IFN-free DAA therapy, particularly the DCV/ASV regimen, showed resistance to this regimen.

Indexed as

AgedAged, 80 and overAntiviral AgentsBenzazepinesCarbamatesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesIndolesIsoquinolinesJapanMale8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamideAntiviral AgentsasunaprevirBenzazepinesCarbamatesdaclatasvirImidazolesIndolesIsoquinolinesPyrrolidinesSulfonamidesValineAsunaprevirBeclabuvirChronic hepatitis CDaclatasvirReal-world effectiveness

Identifiers

PMID30848363
OpenAlexW2920897048

What OpenQuestion holds

Textmetadata
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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.