Evidence map›Paper›PMID 29152781›Full record

Trial reportHepatology (Baltimore, Md.)2018

Glecaprevir/Pibrentasvir in patients with hepatitis C virus genotype 1 or 4 and past direct-acting antiviral treatment failure.

Fred Poordad, Stanislas Pol, Armen Asatryan, Maria Buti, David Shaw, Christophe Hézode, Franco Felizarta, Robert W Reindollar, Stuart C Gordon, Stephen Pianko and 10 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 2 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

57 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  13. Review
  14. Pangenotypic tripleClinical and experimental hepatology · 2023
    Article
  15. Article
  16. Article
  17. Review
  18. Breakthroughs in hepatitis C research: from discovery to cure.Nature reviews. Gastroenterology & hepatology · 2022
    Review
  19. Observational
  20. Article
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

20 authors.

Fred PoordadThe Texas Liver Institute, University of Texas Health, San Antonio, TX.
Stanislas PolGroupe Hospitalier Cochin-Saint Vincent De Paul, Paris, France.
Armen AsatryanAbbVie Inc., North Chicago, IL.
Maria ButiVall d'Hebron University Hospital and CiBERHED del Instituto Carlos III, Barcelona, Spain.
David ShawRoyal Adelaide Hospital, Adelaide, Australia.
Christophe HézodeHôpital Henri Mondor, Université Paris-Est, Créteil, France.
Franco FelizartaPrivate Practice, Bakersfield, CA.
Robert W ReindollarPiedmont Healthcare/Carolinas Center for Liver Disease, Statesville, NC.
Stuart C GordonHenry Ford Health System, Detroit, MI.
Stephen PiankoMonash Health and Monash University, Caulfield South, Victoria, Australia.
Michael W FriedUniversity of North Carolina, Chapel Hill, NC.
David E BernsteinNorth Shore University Hospital, Manhasset, NY.
Joel GallantSouthwest CARE Center, Santa Fe, NM.
Chih-Wei LinAbbVie Inc., North Chicago, IL.
Yang LeiAbbVie Inc., North Chicago, IL.
Teresa I NgAbbVie Inc., North Chicago, IL.
Preethi KrishnanAbbVie Inc., North Chicago, IL.
Sarah Kopecky-BrombergAbbVie Inc., North Chicago, IL.
Jens KortAbbVie Inc., North Chicago, IL.
Federico J MensaAbbVie Inc., North Chicago, IL.

Funding

Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NIDA NIH HHS K24 DA034621
6 · The paper itself

Abstract

Patients with hepatitis C virus (HCV) who have virological failure (VF) after treatment containing a nonstructural protein 5A (NS5A) inhibitor have limited retreatment options. MAGELLAN-1 Part 2 was a randomized, open-label, phase 3 study to evaluate the efficacy and safety of ribavirin (RBV)-free glecaprevir and pibrentasvir (G/P; 300 mg/120 mg) in patients with chronic HCV and past VF on at least one NS3/4A protease and/or NS5A inhibitor-containing therapy. Patients with compensated liver disease, with or without cirrhosis, and HCV genotype (GT) 1, 4, 5, or 6 were randomized 1:1 to receive 12 or 16 weeks of G/P. The primary endpoint was sustained virological response (SVR) at 12 weeks posttreatment (SVR12). Among 91 patients treated, 87 had GT1 and 4 had GT4 infection. SVR12 was achieved by 89% (39 of 44) and 91% (43 of 47) of patients who received 12 and 16 weeks of G/P, respectively. Virological relapse occurred in 9% (4 of 44) of patients treated with 12 weeks of G/P; there were no relapses with 16 weeks of treatment. Past treatment history with one class of inhibitor (protease or NS5A) had no impact on SVR12, whereas past treatment with both classes of inhibitors was associated with lower SVR12 rate. The most common adverse event (AE) was headache (≥10% of patients), and there were no serious AEs assessed as related to study drugs or AEs leading to discontinuation.

conclusionSixteen weeks of G/P treatment achieved a high SVR12 rate in patients with HCV GT1 infection and past failure to regimens containing either NS5A inhibitors or NS3 protease inhibitors. (Hepatology 2018;67:1253-1260).

Indexed as

AdultAgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansLactams, MacrocyclicLeucineMaleMiddle AgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID29152781
PMCPMC5901397

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.