Evidence map›Paper›PMID 28441362›Full record

ArticleInternational journal of molecular sciences2017

Real-World Experiences with the Combination Treatment of Ledipasvir plus Sofosbuvir for 12 Weeks in HCV Genotype 1-Infected Japanese Patients: Achievement of a Sustained Virological Response in Previous Users of Peginterferon plus Ribavirin with HCV NS3/4A Inhibitors.

Tatsuo Kanda, Shin Yasui, Masato Nakamura, Eiichiro Suzuki, Makoto Arai, Yoshihiko Ooka, Sadahisa Ogasawara, Tetsuhiro Chiba, Tomoko Saito, Yuki Haga and 9 more

Abstract read
In one paragraph

Article in International journal of molecular sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Tumor-derived exosomes in the regulation of macrophage polarization.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2020
    Review
  7. Exosomes and Hepatocellular Carcinoma: From Bench to Bedside.International journal of molecular sciences · 2019
    Review
  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. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
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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

19 authors.

Tatsuo KandaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. kandat-cib@umin.ac.jp.
Shin YasuiDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. ntcph863@yahoo.co.jp.
Masato NakamuraDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. nkmr.chiba@gmail.com.
Eiichiro SuzukiDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. eiichiro0709@hotmail.com.
Makoto AraiDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. araim-cib@umin.ac.jp.
Yoshihiko OokaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. ooka-y@umin.ac.jp.
Sadahisa OgasawaraDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. sadahisa@me.com.
Tetsuhiro ChibaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. techiba@faculty.chiba-u.jp.
Tomoko SaitoDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. gcmmg242@yahoo.co.jp.
Yuki HagaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. hagayuki@gmail.com.
Koji TakahashiDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. koji517@gmail.com.
Reina SasakiDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. reina_sasaki_0925@yahoo.co.jp.
Shuang WuDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. gosyou100@yahoo.co.jp.
Shingo NakamotoDepartment of Molecular Virology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. nakamotoer@yahoo.co.jp.
Akinobu TawadaSafety and Health Organization, Chiba University, 1-33 Yayoicho, Inage-ku, Chiba 263-8522, Japan. akinobutawada@hospital.chiba-u.jp.
Hitoshi MaruyamaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. maru-cib@umin.ac.jp.
Fumio ImazekiSafety and Health Organization, Chiba University, 1-33 Yayoicho, Inage-ku, Chiba 263-8522, Japan. imazekif@faculty.chiba-u.jp.
Naoya KatoDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. kato-2im@ims.u-tokyo.ac.jp.
Osamu YokosukaDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. yokosukao@faculty.chiba-u.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to characterize the treatment response and serious adverse events of ledipasvir plus sofosbuvir therapies in Japanese patients infected with hepatitis C virus (HCV) genotype 1 (GT1). This retrospective study analyzed 240 Japanese HCV GT1 patients treated for 12 weeks with 90 mg of ledipasvir plus 400 mg of sofosbuvir daily. Sustained virological response at 12 weeks post-treatment (SVR12) was achieved in 236 of 240 (98.3%) patients. Among treatment-naïve patients, SVR12 was achieved in 136 of 138 (98.6%) patients, and among treatment-experienced patients, SVR12 was achieved in 100 of 102 (98.0%) patients. In patients previously treated with peginterferon plus ribavirin with various HCV NS3/4A inhibitors, 100% SVR rates (25/25) were achieved. Two relapsers had HCV NS5A resistance-associated variants (RAVs), but no HCV NS5B-S282 was observed after they relapsed. We experienced two patients with cardiac events during treatment. In conclusion, combination of ledipasvir plus sofosbuvir for 12 weeks is a potential therapy for HCV GT1 patients. Caution is needed for HCV NS5A RAVs, which were selected by HCV NS5A inhibitors and cardiac adverse events.

Indexed as

AgedAntiviral AgentsAsian PeopleBenzimidazolesCarrier ProteinsDEAD-box RNA HelicasesDrug Administration ScheduleDrug Resistance, ViralDrug Therapy, CombinationFemaleFluorenesGenotypeHepacivirusHepatitis C, ChronicHumansInterferon-alphaAntiviral AgentsBenzimidazolesCarrier ProteinsDEAD-box RNA HelicasesFluorenesInterferon-alphaInterferon Lambdainterferon-lambda, humanInterferonsInterleukinsIntracellular Signaling Peptides and ProteinsledipasvirNS3 protein, hepatitis C virusNS4A cofactor peptide, Hepatitis C virusNucleoside-Triphosphatasepeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, ViralSerine EndopeptidasesSofosbuvirViral Nonstructural ProteinsViral Proteasesgenotype 1hepatitis C virusledipasvirNS3/4A inhibitorssofosbuvir

Identifiers

PMID28441362
PMCPMC5454819

What OpenQuestion holds

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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.