Evidence map›Paper›PMID 28128852›Full record

Trial reportHepatology (Baltimore, Md.)2017

Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment.

Fred Poordad, Franco Felizarta, Armen Asatryan, Mark S Sulkowski, Robert W Reindollar, Charles S Landis, Stuart C Gordon, Steven L Flamm, Michael W Fried, David E Bernstein and 6 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02446717 (A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530), which is not on this map. Cited by 78 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 3 pooled it
21.8field-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.

NCT02446717 phase2 / phase3completednot on this map

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled141ConditionsChronic Hepatitis C, Hepatitis C Virus, HCV, Direct-Acting Antiviral Agent (DAA)-ExperiencedArmsABT-493, ABT-530, ribavirin (RBV), ABT-493/ABT-530
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 3 syntheses or guidelines pooled it, 201 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  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. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Liver diseases: epidemiology, causes, trends and predictions.Signal transduction and targeted therapy · 2025
    Review
  15. Article
  16. Review
  17. Pangenotypic tripleClinical and experimental hepatology · 2023
    Article
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Fred PoordadTexas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
Franco FelizartaPrivate Practice, Bakersfield, CA.
Armen AsatryanAbbVie Inc, North Chicago, IL.
Mark S SulkowskiJohns Hopkins University School of Medicine, Baltimore, MD.
Robert W ReindollarPiedmont Healthcare/Carolinas Center for Liver Disease, Statesville, NC.
Charles S LandisDivision of Gastroenterology, University of Washington, Seattle, WA.
Stuart C GordonHenry Ford Health System, Detroit, MI.
Steven L FlammNorthwestern Feinberg School of Medicine, Chicago, IL.
Michael W FriedUniversity of North Carolina, Chapel Hill, NC.
David E BernsteinNorth Shore University Hospital, Manhasset, NY.
Chih-Wei LinAbbVie Inc, North Chicago, IL.
Ran LiuAbbVie Inc, North Chicago, IL.
Sandra S LovellAbbVie Inc, North Chicago, IL.
Teresa I NgAbbVie Inc, North Chicago, IL.
Jens KortAbbVie Inc, North Chicago, IL.
Federico J MensaAbbVie Inc, North Chicago, IL.
AbbVie (United States) · USBakersfield College · USHenry Ford Health System · USJohns Hopkins University · USNorth Shore University Hospital · USPiedmont HealthCare · USTexas Liver Institute · USUniversity of North Carolina at Chapel Hill · USUniversity of Washington · US

Funding

Management/Hepatitis C/HIV-infected and Uninfected IDU'sR01DA016065 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2003 to 2018
$8.0M
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

Although direct-acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection have demonstrated high rates of sustained virologic response, virologic failure may still occur, potentially leading to the emergence of viral resistance, which can decrease the effectiveness of subsequent treatment. Treatment options for patients who failed previous DAA-containing regimens, particularly those with nonstructural protein 5A inhibitors, are limited and remain an area of unmet medical need. This phase 2, open-label study (MAGELLAN-1) evaluated the efficacy and safety of glecaprevir (GLE) + pibrentasvir (PIB) ± ribavirin (RBV) in HCV genotype 1-infected patients with prior virologic failure to HCV DAA-containing therapy. A total of 50 patients without cirrhosis were randomized to three arms: 200 mg GLE + 80 mg PIB (arm A), 300 mg GLE + 120 mg PIB with 800 mg once-daily RBV (arm B), or 300 mg GLE + 120 mg PIB without RBV (arm C). By intent-to-treat analysis, sustained virologic response at posttreatment week 12 was achieved in 100% (6/6, 95% confidence interval 61-100), 95% (21/22, 95% confidence interval 78-99), and 86% (19/22, 95% confidence interval 67-95) of patients in arms A, B, and C, respectively. Virologic failure occurred in no patients in arm A and in 1 patient each in arms B and C (two patients were lost to follow-up in arm C). The majority of adverse events were mild in severity; no serious adverse events related to study drug and no relevant laboratory abnormalities in alanine aminotransferase, total bilirubin, or hemoglobin were observed.

conclusionThe combination of GLE and PIB was highly efficacious and well tolerated in patients with HCV genotype 1 infection and prior failure of DAA-containing therapy; RBV coadministration did not improve efficacy. (Hepatology 2017;66:389-397).

Indexed as

Administration, OralAdolescentAdultAgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesConfidence IntervalsCyclopropanesDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirInterferon-alphaLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesRibavirinSulfonamides

Identifiers

PMID28128852
PMCPMC5573922
OpenAlexW2667085915

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.