Evidence map›Paper›PMID 29052790›Full record

Trial reportJournal of gastroenterology2018

Efficacy and safety of glecaprevir/pibrentasvir in HCV-infected Japanese patients with prior DAA experience, severe renal impairment, or genotype 3 infection.

Hiromitsu Kumada, Tsunamasa Watanabe, Fumitaka Suzuki, Kenji Ikeda, Ken Sato, Hidenori Toyoda, Masanori Atsukawa, Akio Ido, Akinobu Takaki, Nobuyuki Enomoto and 10 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 60 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 3 pooled it
12.0field-weighted citation impact, top 1% 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

60 citing papers in PubMed, 3 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Observational
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Observational
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 2 countries.

Hiromitsu KumadaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan. kumahiro@toranomon.gr.jp.
Tsunamasa WatanabeDepartment of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Fumitaka SuzukiDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Kenji IkedaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Ken SatoDepartment of Medicine and Molecular Science, Gunma University Hospital, Maebashi, Japan.
Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital, Gifu, Japan.
Masanori AtsukawaDepartment of Internal Medicine, Nippon Medical School, Tokyo, Japan.
Akio IdoDepartment of Human and Environmental Sciences, Kagoshima University Hospital, Kagoshima, Japan.
Akinobu TakakiDepartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Nobuyuki EnomotoThe First Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan.
Koji KatoAbbVie Inc., North Chicago, IL, USA.
Katia AlvesAbbVie Inc., North Chicago, IL, USA.
Margaret BurroughsAbbVie Inc., North Chicago, IL, USA.
Rebecca RedmanAbbVie Inc., North Chicago, IL, USA.
David PugatchAbbVie Inc., North Chicago, IL, USA.
Tami J Pilot-MatiasAbbVie Inc., North Chicago, IL, USA.
Preethi KrishnanAbbVie Inc., North Chicago, IL, USA.
Rajneet K OberoiAbbVie Inc., North Chicago, IL, USA.
Wangang XieAbbVie Inc., North Chicago, IL, USA.
Kazuaki ChayamaDepartment of Gastroenterology and Metabolism, Institute of Biomedical and Health Sciences, Hiroshima University Hospital, Hiroshima, Japan.
AbbVie (United States) · USToranomon Hospital · JPGunma University Hospital · JPHiroshima University Hospital · JPKagoshima University Hospital · JPNippon Medical School · JPOgaki Municipal Hospital · JPOkayama University · JPSt. Marianna University School of Medicine · JPUniversity of Yamanashi · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnce-daily, orally administered, co-formulated glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P) demonstrated pangenotypic activity and high sustained virologic response (SVR) rates in studies outside Japan. Here we report safety and efficacy in a subset of Japanese patients with chronic HCV infection who received G/P 300/120 mg in a phase 3, open-label, multicenter study (CERTAIN-1).

methodsThis analysis focuses on three difficult-to-treat subgroups: HCV GT1/2-infected patients who failed to achieve SVR after treatment with a direct acting antiviral (DAA)-containing regimen; GT1/2-infected patients with severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m

resultsThe study enrolled 33 GT1/2-infected patients who failed previous DAA treatment (four with cirrhosis); 12 GT1/2-infected patients with severe renal impairment (two with cirrhosis); and 12 GT3-infected patients (two with cirrhosis). SVR

conclusionsG/P achieved high SVR

Indexed as

AdolescentAdultAgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansLactams, MacrocyclicLeucineMaleAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesRNA, ViralSulfonamidesCirrhosisGlecaprevirPibrentasvirRenal failureSpecial population

Identifiers

PMID29052790
PMCPMC5866827
OpenAlexW2766054212

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.