Evidence map›Paper›PMID 29740665›Full record

ArticleJournal of gastroenterology2018

Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan.

Hidenori Toyoda, Masanori Atsukawa, Koichi Takaguchi, Tomonori Senoh, Kojiro Michitaka, Atsushi Hiraoka, Shinichi Fujioka, Chisa Kondo, Tomomi Okubo, Haruki Uojima and 23 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Real-world safety and efficacy of sofosbuvir and ledipasvir for elderly patients.JGH open : an open access journal of gastroenterology and hepatology · 2018
    Article
  10. 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

33 authors.

Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, Gifu, 503-8502, Japan. hmtoyoda@spice.ocn.ne.jp.ORCID http://orcid.org/0000-0002-1652-6168
Masanori AtsukawaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
Koichi TakaguchiDepartment of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.
Tomonori SenohDepartment of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.
Kojiro MichitakaGastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Atsushi HiraokaGastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Shinichi FujiokaDepartment of Gastroenterology, Okayama Saiseikai General Hospital, Okayama, Japan.
Chisa KondoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
Tomomi OkuboDivision of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.
Haruki UojimaDepartment of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
Toshifumi TadaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, Gifu, 503-8502, Japan.
Hirohito YoneyamaDepartment of Gastroenterology and Neurology, Kagawa University School of Medicine, Kida, Japan.
Tsunamasa WatanabeDepartment of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Toru AsanoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Toru IshikawaDepartment of Hepatology, Saiseikai Niigata Daini Hospital, Niigata, Japan.
Hideyuki TamaiDepartment of Hepatology, Wakayama Rosai Hospital, Wakayama, Japan.
Hiroshi AbeDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatusdo Central General Hospital, Matsudo, Japan.
Keizo KatoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatusdo Central General Hospital, Matsudo, Japan.
Kunihiko TsujiCenter of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.
Chikara OgawaDepartment of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
Noritomo ShimadaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital, Kashiwa, Japan.
Etsuko IioDepartment of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
Akihiro DeguchiDepartment of Gastroenterology, Kagawa Rosai Hospital, Marugame, Japan.
Ei ItobayashiDepartment of Gastroenterology, Asahi General Hospital, Asahi, Japan.
Shigeru MikamiDivision of Gastroenterology, Department of Internal Medicine, Kikkoman General Hospital, Noda, Japan.
Akio MoriyaDepartment of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan.
Hironao OkuboDepartment of Gastroenterology, Juntendo University Nerima Hospital, Tokyo, Japan.
Joji TaniDepartment of Internal Medicine, Yashima General Hospital, Takamatsu, Japan.
Akihito TsubotaCore Research Facilities for Basic Science, The Jikei University School of Medicine, Tokyo, Japan.
Yasuhito TanakaDepartment of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
Tsutomu MasakiDepartment of Gastroenterology and Neurology, Kagawa University School of Medicine, Kida, Japan.
Katsuhiko IwakiriDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
Takashi KumadaDepartment of Gastroenterology, Ogaki Municipal Hospital, 4-86 Minaminokawa, Ogaki, Gifu, 503-8502, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe real-world virological efficacy and safety of an interferon (IFN)-free direct-acting antiviral (DAA) therapy with elbasvir (EBR) and grazoprevir (GZR) were evaluated in Japanese patients chronically infected with hepatitis C virus (HCV) genotype 1.

methodsThe rate of sustained virologic response (SVR) and safety were analyzed in patients who started the EBR/GZR regimen between November 2016 and July 2017. SVR rates were compared based on patient baseline characteristics.

resultsOverall, 371 of 381 patients (97.4%) achieved SVR. Multivariate analysis identified a history of failure to IFN-free DAA therapy and the presence of double resistance-associated substitutions (RASs) in HCV non-structural protein 5A (NS5A) as factors significantly associated with failure to EBR/GZR treatment. The SVR rates of patients with a history of IFN-free DAA therapy and those with double RASs were 55.6 and 63.6%, respectively. In all other subpopulations, the SVR rates were more than 90%. There were no severe adverse events associated with the treatment.

conclusionsThe EBR/GZR regimen yielded high virological efficacy with acceptable safety. Patients with a history of failure to IFN-free DAA therapy or with double RASs in HCV-NS5A remained difficult to treat with this regimen.

Indexed as

AgedAged, 80 and overAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropanesDrug Resistance, ViralDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropaneselbasvirgrazoprevirImidazolesLactams, MacrocyclicQuinoxalinesSulfonamidesChronic hepatitis CEfficacyElbasvirGenotype 1GrazoprevirReal worldSafety

Identifiers

PMID29740665

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.