Evidence map›Paper›PMID 34125405›Full record

ArticleInfectious diseases and therapy2021

Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir.

Alessio Aghemo, Yves Horsmans, Stefan Bourgeois, Mark Bondin, Michael Gschwantler, Harald Hofer, Nasser Semmo, Francesco Negro, Zhenzhen Zhang, John Marcinak and 12 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Infectious diseases and therapy, 2021. 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 NCT03303599 (Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.4field-weighted citation impact, top 9% 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.

NCT03303599 completednot on this map

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

TypeobservationalSponsorAbbVieRan2017 to 2020Enrolled2,118ConditionsHepatitis C
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
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  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 20 institutions in 12 countries.

Alessio AghemoDepartment of Biomedical Sciences, Humanitas University, Rozzano, Italy. Alessio.aghemo@hunimed.eu.
Yves HorsmansCliniques Universitaires Saint-Luc, UCL, Brussels, Belgium.
Stefan BourgeoisStuivenberg ZNA, Antwerp, Belgium.
Mark BondinAbbVie Inc, North Chicago, IL, USA.
Michael GschwantlerDepartment of Internal Medicine IV, Wilhelminenspital, and Sigmund Freud University, Vienna, Austria.
Harald HoferDepartment of Internal Medicine, Gastroenterology and Hepatology, Klinikum Wels-Grieskirchen, Wels, Austria.
Nasser SemmoDepartment of BioMedical Research, Hepatology, Inselspital, University of Bern, 3010, Bern, Switzerland.
Francesco NegroDivision of Gastroenterology and Hepatology, University Hospital, Geneva, Switzerland.
Zhenzhen ZhangAbbVie Inc, North Chicago, IL, USA.
John MarcinakAbbVie Inc, North Chicago, IL, USA.
Ella VeitsmanLiver Unit, Rambam Health Care Campus, Haifa, Israel.
Rawi HazzanEmek Medical Center, Afula, Israel.
Konstantinos MimidisFirst Department of Internal Medicine, Democritus University of Thrace Medical School, Alexandroupolis, Greece.
Ioannis Goulis4th Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Nuno MarquesInfectious Diseases Service, Hospital Garcia de Orta EPE, Almada, Portugal.
Robert FlisiakDepartment of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
Wlodzimierz MazurClinical Department of Infectious Diseases, Medical University of Silesia, Katowice, Poland.
Carlos RonceroPsychiatry Service, University of Salamanca Health Care Complex, Salamanca, Spain.
Fiona MarraHepatology Drug Interactions Group, University of Liverpool, Liverpool, UK.
Georges Philippe PageauxDépartement Hépato-Gastro-Entérologie, Centre Hospitalier Universitaire (CHU) de Montpellier, Montpellier Cedex 5, France.
Tarik AsselahDepartment of Hepatology, Hopital Beaujon, AP-HP, Paris University and INSERM UMR 1149, Clichy, France.
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.
AbbVie (United States) · USAristotle University of Thessaloniki · GRCentre Hospitalier Universitaire de Montpellier · FRCliniques Universitaires Saint-Luc · BEDemocritus University of Thrace · GREmek Medical Center · ILHôpital Beaujon · FRHospital Garcia de Orta · PTHumanitas University · ITKlinikum Wels-Grieskirchen · ATMedical University of Białystok · PLMedical University of Silesia · PLOspedale Maggiore · ITRambam Health Care Campus · ILSigmund Freud University Vienna · ATUniversidad de Salamanca · ESUniversity Hospital of Bern · CHUniversity Hospital of Geneva · CHUniversity of Liverpool · GBZiekenhuisnetwerk Antwerpen Stuivenberg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGlecaprevir/pibrentasvir is approved for treating chronic hepatitis C virus (HCV) genotypes (GT) 1-6. We evaluated real-world effectiveness, safety, and patient-reported outcomes of glecaprevir/pibrentasvir in underserved patient populations, focusing on persons who use drugs infected with HCV.

methodsData were pooled from nine countries (13 November 2017-31 January 2020). Patients had HCV GT1-6, with or without compensated cirrhosis, with or without prior HCV treatment and received glecaprevir/pibrentasvir consistent with local label at their physician's discretion. Patients with prior direct-acting antiviral exposure were excluded from efficacy and quality-of-life analyses. The percentage of patients achieving sustained virologic response at post-treatment week 12 (SVR12) was assessed. Mean changes from baseline to SVR12 visit in 36-Item Short-Form Health Survey mental and physical component summary scores were reported. Safety was assessed in patients receiving at least one dose of glecaprevir/pibrentasvir.

resultsOf 2036 patients, 1701 (83.5%) received 8-week glecaprevir/pibrentasvir. In 1684 patients with sufficient follow-up, SVR12 rates were 98.0% (1651/1684) overall, 98.1% (1432/1459) in 8-week treated patients, 97.0% (519/535) in persons who use drugs, and greater than 95% across subgroups. Mean changes from baseline in mental and physical component summary scores were 3.7 and 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event was reported; six glecaprevir/pibrentasvir-related adverse events led to discontinuation.

conclusionsGlecaprevir/pibrentasvir was highly effective, well tolerated, and improved quality of life in HCV-infected persons who use drugs and other underserved patients.

trial registrationThese multinational post-marketing observational studies are registered with ClinicalTrials.gov, number NCT03303599.

Indexed as

Alcohol use disorderHealth-related quality of lifeHepatitis CIllicit drugsPsychiatric disorders

Identifiers

PMID34125405
PMCPMC8572930
OpenAlexW3169832432

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.