Evidence map›Paper›PMID 28926120›Full record

Trial reportHepatology (Baltimore, Md.)2018

Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial.

David Wyles, Fred Poordad, Stanley Wang, Laurent Alric, Franco Felizarta, Paul Y Kwo, Benedict Maliakkal, Kosh Agarwal, Tarek Hassanein, Frank Weilert and 8 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 59 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 6 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

59 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Guideline
  4. Pooled it
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  6. Pooled it
  7. Trial
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  10. 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
  11. Trial
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  16. Review
  17. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  18. Article
  19. Article
  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

18 authors.

David WylesDenver Health Medical Center, Denver, CO.
Fred PoordadThe Texas Liver Institute, University of Texas Health, San Antonio, TX.
Stanley WangAbbVie Inc., North Chicago, IL.
Laurent AlricDepartment of Internal Medicine and Digestive Diseases, CHU Purpan, UMR 152, IRD Toulouse 3 University, Toulouse, France.ORCID 0000-0003-0676-7539
Franco FelizartaPrivate Practice, Bakersfield, CA.
Paul Y KwoDivision of Gastroenterology and Hepatology, Stanford University, Palo Alto, CA.
Benedict MaliakkalUniversity of Tennessee Health Science Center, Memphis, TN.
Kosh AgarwalInstitute of Liver Studies, Kings College Hospital, London, UK.
Tarek HassaneinSouthern California GI and Liver Centers and Southern California Research Center, Coronado, CA.
Frank WeilertTawa Street Specialist Clinic, Hamilton, New Zealand.
Samuel S LeeUniversity of Calgary, Calgary, AB, Canada.
Jens KortAbbVie Inc., North Chicago, IL.
Sandra S LovellAbbVie Inc., North Chicago, IL.
Ran LiuAbbVie Inc., North Chicago, IL.
Chih-Wei LinAbbVie Inc., North Chicago, IL.
Tami Pilot-MatiasAbbVie Inc., North Chicago, IL.
Preethi KrishnanAbbVie Inc., North Chicago, IL.
Federico J MensaAbbVie Inc., North Chicago, IL.

Funding

AbbVie NCT02243293
6 · The paper itself

Abstract

This study assessed the efficacy and safety of ribavirin-free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. SURVEYOR-II, Part 3 was a partially randomized, open-label, multicenter, phase 3 study. Treatment-experienced (prior interferon or pegylated interferon ± ribavirin or sofosbuvir plus ribavirin ± pegylated interferon therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily. Treatment-naive or treatment-experienced patients with compensated cirrhosis were treated with G/P for 12 or 16 weeks, respectively. The primary efficacy endpoint was the percentage of patients with sustained virologic response at posttreatment week 12 (SVR12). Safety was evaluated throughout the study. There were 131 patients enrolled and treated. Among treatment-experienced patients without cirrhosis, SVR12 was achieved by 91% (20/22; 95% confidence interval [CI], 72-97) and 95% (21/22; 95% CI, 78-99) of patients treated with G/P for 12 or 16 weeks, respectively. Among those with cirrhosis, SVR12 was achieved by 98% (39/40; 95% CI, 87-99) of treatment-naive patients treated for 12 weeks and 96% (45/47; 95% CI, 86-99) of patients with prior treatment experience treated for 16 weeks. No adverse events led to discontinuation of study drug, and no serious adverse events were related to study drug. Conclusion: Patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated. (Hepatology 2018;67:514-523).

Indexed as

AdultAgedAlanine TransaminaseAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesDrug Therapy, CombinationFemaleGenotypeHepatitis C, ChronicHumansLactams, MacrocyclicLeucineLiver CirrhosisMaleAlanine TransaminaseAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID28926120
PMCPMC5817409

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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.