Evidence map›Paper›PMID 30203225›Full record

Trial reportJournal of gastroenterology2019

Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial.

Tetsuo Takehara, Naoya Sakamoto, Shuhei Nishiguchi, Fusao Ikeda, Tomohide Tatsumi, Yoshiyuki Ueno, Hiroshi Yatsuhashi, Yasuhiro Takikawa, Tatsuo Kanda, Minoru Sakamoto and 11 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 63 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 3 pooled it
7.1field-weighted citation impact, top 2% 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

63 citing papers in PubMed, 3 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. [Recent Advances in the Treatment of Chronic Hepatitis C].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 15 institutions in 2 countries.

Tetsuo TakeharaOsaka University, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0001-5036-3457
Naoya SakamotoHokkaido University, Sapporo, Hokkaido, Japan.
Shuhei NishiguchiHyogo College of Medicine, Nishinomiya, Hyogo, Japan.
Fusao IkedaOkayama University, Okayama, Japan.
Tomohide TatsumiOsaka University, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Yoshiyuki UenoYamagata University, Yamagata, Japan.
Hiroshi YatsuhashiNagasaki Medical Center, Nagasaki, Japan.
Yasuhiro TakikawaIwate Medical University, Iwate, Japan.
Tatsuo KandaChiba University, Chiba, Japan.
Minoru SakamotoUniversity of Yamanashi, Yamanashi, Japan.
Akihiro TamoriOsaka City University, Osaka, Japan.
Eiji MitaNational Hospital Organization Osaka National Hospital, Osaka, Japan.
Kazuaki ChayamaHiroshima University, Hiroshima, Japan.
Gulan ZhangGilead Sciences, Inc, Foster City, CA, USA.
Shampa De-OertelGilead Sciences, Inc, Foster City, CA, USA.
Hadas Dvory-SobolGilead Sciences, Inc, Foster City, CA, USA.
Takuma MatsudaGilead Sciences K.K, Tokyo, Japan.
Luisa M StammGilead Sciences, Inc, Foster City, CA, USA.
Diana M BrainardGilead Sciences, Inc, Foster City, CA, USA.
Yasuhito TanakaNagoya City University, Nagoya, Aichi, Japan.
Masayuki KurosakiMusashino Red Cross Hospital, Tokyo, Japan.
Gilead Sciences (United States) · USThe University of Osaka · JPChiba University · JPHiroshima University · JPHokkaido University · JPHyogo Medical University · JPIwate Medical University · JPMusashino Red Cross Hospital · JPNagasaki Medical Center · JPNagoya City University · JPOkayama University · JPOsaka City University · JPOsaka National Hospital · JPUniversity of Yamanashi · JPYamagata University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Japan, hepatitis C virus (HCV)-infected patients with decompensated cirrhosis currently have no treatment options. In this Phase 3 study, we evaluated sofosbuvir-velpatasvir with or without ribavirin for 12 weeks in patients with any HCV genotype and decompensated cirrhosis [Child-Pugh-Turcotte (CPT) class B or C] in Japan.

methodsPatients were randomized 1:1 to receive sofosbuvir-velpatasvir with or without ribavirin for 12 weeks. Randomization was stratified by CPT class and genotype. Sustained virologic response 12 weeks following completion of treatment (SVR12) was the primary efficacy endpoint.

resultsOf the 102 patients enrolled, 57% were treatment naive, 78% and 20% had genotype 1 and 2 HCV infection, respectively, and 77% and 20% had CPT class B and C cirrhosis, respectively, at baseline. Overall, 61% of patients were female and the mean age was 66 years (range 41-83). SVR12 rates were 92% (47/51) in each group. Among patients who achieved SVR12, 26% had improved CPT class from baseline to posttreatment week 12. Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin. Four patients (8%) who received sofosbuvir-velpatasvir and seven (14%) who received sofosbuvir-velpatasvir plus ribavirin experienced a serious AE. The 3 deaths (bacterial sepsis, gastric varices hemorrhage, hepatocellular carcinoma) were attributed to liver disease progression.

conclusionSofosbuvir-velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Indexed as

AdultAgedAged, 80 and overAntiviral AgentsCarbamatesDrug CombinationsFemaleGenotypeHepacivirusHepatitis CHeterocyclic Compounds, 4 or More RingsHumansJapanLiver CirrhosisMaleMiddle AgedAntiviral AgentsCarbamatesDrug CombinationsHeterocyclic Compounds, 4 or More RingsRibavirinSofosbuvirsofosbuvir-velpatasvir drug combinationAdvanced liver diseaseDecompensated cirrhosisDirect-acting antiviralsSofosbuvirVelpatasvir

Identifiers

PMID30203225
PMCPMC6314981
OpenAlexW2890344022

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.