Evidence map›Paper›PMID 35543964›Full record

ArticleAdvances in therapy2022

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study.

Markus Cornberg, Adriana Ahumada, Alessio Aghemo, Massimo Andreoni, Abhi Bhagat, Isabel Butrymowicz, Michal Carmiel, Gabriel Chodick, Brian Conway, Yanna Song and 13 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
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  3. Observational
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  6. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
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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 20 institutions in 6 countries.

Markus CornbergDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany. cornberg.markus@mh-hannover.de.ORCID http://orcid.org/0000-0002-9141-8001
Adriana AhumadaLiver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Alessio AghemoDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
Massimo AndreoniUniversity of Tor Vergata, Rome, Italy.
Abhi BhagatAbbVie Inc., North Chicago, Illinois, USA.
Isabel ButrymowiczAbbVie Inc., North Chicago, Illinois, USA.
Michal CarmielLiver Unit, Galilee Medical Center, Nahariya, Israel.
Gabriel ChodickMaccabitech, Maccabi Healthcare Services, Tel-Aviv, Israel.
Brian ConwayVancouver Infectious Diseases Center and Simon Fraser University, Vancouver, BC, Canada.
Yanna SongAbbVie Inc., North Chicago, Illinois, USA.
Antonio GasbarriniInternal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Dietrich HüppeGastroenterologische Gemeinschaftspraxis Herne, Herne, Germany.
Francisco Jorquera PlazaDigestive System Service, Complejo Asistencial Universitario de León, IBIOMED and CIBERehd, León, Spain.
Pietro LamperticoFoundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Policlinico-Division of Gastroenterology and Hepatology, CRC 'AM and A Migliavacca' Centre for Liver Disease, Milan, Italy.
Maria Luisa Manzano AlonsoLiver Unit, Hospital Universitario, 12 De Octubre, Madrid, Spain.
Lindsay MylesBarrie GI Associates, Barrie, ON, Canada.
Marcello PersicoDipartimento di Medicina Clinica Medica, Epatologica e Lungodegenza, AOU OO. RR. San Giovanni di Dio Ruggi e D'Aragona, Salerno, Italy.
Alnoor RamjiUniversity of British Columbia, Vancouver, BC, Canada.
Christoph SarrazinDepartment of Internal Medicine and Livercenter, St. Josefs-Hospital Wiesbaden and Viral Hepatitis Research Group, Goethe-University Hospital Frankfurt, Frankfurt, Germany.
Erica VillaUC Gastroenterologia, Dipartimento di Specialità Mediche, Azienda Ospedaliera Universitaria di Modena, Modena, Italy.
Clara WeilMaccabitech, Maccabi Healthcare Services, Tel-Aviv, Israel.
Juan Isidro Uriz OtanoNavarra Institute for Health Research (IdiSNA), Pamplona, Spain.
CREST Study Group
AbbVie (United States) · USAgostino Gemelli University Polyclinic · ITAzienda Ospedaliero-Universitaria di Modena · ITBar-Ilan University · ILBarrie Urology Group · CACentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESComplejo Hospitalario de Navarra · ESGoethe University Frankfurt · DEHospital General Universitario Gregorio Marañón · ESHospital Universitario 12 De Octubre · ESHumanitas University · ITMaccabi Healthcare Services · ILMedizinische Hochschule Hannover · DEOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITPraxis für Humangenetik · DESimon Fraser University · CATel Aviv University · ILUniversity of British Columbia · CAUniversity of Milan · ITUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn clinical trials with hepatitis C virus-infected treatment-naïve (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest.

methodsThe CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed.

resultsA total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan

conclusionIn this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.

Indexed as

Hepatitis CHepatitis C, ChronicAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesGenotypeHepacivirusHumansLactams, MacrocyclicLeucineLiver CirrhosisProlinePyrrolidinesQuinoxalinesRetrospective StudiesAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidesCompensated cirrhosisDirect-acting antiviralsHepatitis C virusReal worldTreatment-naïve

Identifiers

PMID35543964
PMCPMC9239949
OpenAlexW4280570876

What OpenQuestion holds

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LicenceCC BY-NC
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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.