Evidence map›Paper›PMID 30421537›Full record

Trial reportJournal of viral hepatitis2019

Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis.

Steven Flamm, David Mutimer, Armen Asatryan, Stanley Wang, Jürgen Rockstroh, Yves Horsmans, Paul Y Kwo, Ola Weiland, Erica Villa, Jeong Heo and 13 more

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of viral hepatitis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 5% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Genotype 3-hepatitis C virus' last line of defense.World journal of gastroenterology · 2021
    Review
  16. Review
  17. Article
  18. Observational
  19. Article
  20. 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

23 authors at 15 institutions in 8 countries.

Steven FlammNorthwestern Feinberg School of Medicine, Chicago, Illinois.
David MutimerQueen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.
Armen AsatryanAbbVie Inc, North Chicago, Illinois.
Stanley WangAbbVie Inc, North Chicago, Illinois.
Jürgen RockstrohUniversitätsklinikum Bonn, Bonn, Germany.
Yves HorsmansCliniques Universitaires Saint-Luc, UCL, Brussels, Belgium.
Paul Y KwoDivision of Gastroenterology and Hepatology, Stanford University, Palo Alto, California.
Ola WeilandKarolinska University Hospital Huddinge at Karolinska Institute, Stockholm, Sweden.ORCID 0000-0002-6934-9724
Erica VillaUniversity of Modena and Reggio Emilia, Modena, Italy.
Jeong HeoDepartment of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.
Edward GaneLiver Unit, Auckland City Hospital, Auckland, New Zealand.
Stephen D RyderNIHR Nottingham Biomedical Research Centre and Nottingham University Hospitals NHS Trust, Nottingham, UK.
Tania M WelzelJW Goethe University Hospital, Frankfurt, Germany.
Peter J RuaneRuane Medical & Liver Health Institute, Los Angeles, California.
Kosh AgarwalInstitute of Liver Studies, Kings College Hospital, London, UK.ORCID 0000-0002-4754-828X
Teresa I NgAbbVie Inc, North Chicago, Illinois.
Zhenyi XueAbbVie Inc, North Chicago, Illinois.
Sandra S LovellAbbVie Inc, North Chicago, Illinois.
Preethi KrishnanAbbVie Inc, North Chicago, Illinois.
Sarah Kopecky-BrombergAbbVie Inc, North Chicago, Illinois.
Roger TrinhAbbVie Inc, North Chicago, Illinois.
Federico J MensaAbbVie Inc, North Chicago, Illinois.
David L WylesDenver Health Medical Center, Denver, Colorado.
AbbVie (United States) · USAuckland City Hospital · NZCliniques Universitaires Saint-Luc · BEDenver Health Medical Center · USGoethe University Frankfurt · DEKarolinska University Hospital · SEKing's College Hospital · GBNorthwestern University · USNottingham University Hospitals NHS Trust · GBPalo Alto University · USPusan National University Hospital · KRQueen Elizabeth Hospital Birmingham · GBRuane Medical · USUniversity Hospital Bonn · DEUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Glecaprevir coformulated with pibrentasvir (G/P) is approved to treat hepatitis C virus (HCV) infection and was highly efficacious in phase 2 and 3 studies. Treating HCV genotype (GT) 3 infection remains a priority, as these patients are harder to cure and at a greater risk for liver steatosis, fibrosis progression and hepatocellular carcinoma. Data were pooled from five phase 2 or 3 trials that evaluated 8-, 12- and 16-week G/P in patients with chronic HCV GT3 infection. Patients without cirrhosis or with compensated cirrhosis were either treatment-naïve or experienced with interferon- or sofosbuvir-based regimens. Safety and sustained virologic response 12 weeks post-treatment (SVR12) were assessed. The analysis included 693 patients with GT3 infection. SVR12 was achieved by 95% of treatment-naïve patients without cirrhosis receiving 8-week (198/208) and 12-week (280/294) G/P. Treatment-naïve patients with cirrhosis had a 97% (67/69) SVR12 rate with 12-week G/P. Treatment-experienced, noncirrhotic patients had SVR12 rates of 90% (44/49) and 95% (21/22) with 12- and 16-week G/P, respectively; 94% (48/51) of treatment-experienced patients with cirrhosis treated for 16 weeks achieved SVR12. No serious adverse events (AEs) were attributed to G/P; AEs leading to study drug discontinuation were rare (<1%). G/P was well-tolerated and efficacious for patients with chronic HCV GT3 infection, regardless of cirrhosis status or prior treatment experience. Eight- and 12-week durations were efficacious for treatment-naïve patients without cirrhosis and with compensated cirrhosis, respectively; 16-week G/P was efficacious in patients with prior treatment experience irrespective of cirrhosis status.

Indexed as

AdolescentAdultAgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesData Interpretation, StatisticalDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansLactams, MacrocyclicLeucineAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidescirrhosisG/PGT3hepatitis C virusPWID

Identifiers

PMID30421537
PMCPMC7379735
OpenAlexW2901390919

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.