Evidence map›Paper›PMID 31646465›Full record

ArticleAdvances in therapy2019

Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study.

Robert J Fontana, Sabela Lens, Stuart McPherson, Magdy Elkhashab, Victor Ankoma-Sey, Mark Bondin, Ana Gabriela Pires Dos Santos, Zhenyi Xue, Roger Trinh, Ariel Porcalla and 1 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03212521 (A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir), 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
1.1field-weighted citation impact, top 22% 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.

NCT03212521 phase3completednot on this map

A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

TypeinterventionalSponsorAbbVieRan2017 to 2018Enrolled230ConditionsHepatitis C Virus (HCV)ArmsGlecaprevir/Pibrentasvir
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Liver cTAbdominal radiology (New York) · 2021
    Article
  4. Article
  5. Review
  6. 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

11 authors at 7 institutions in 5 countries.

Robert J FontanaDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA. rfontana@med.umich.edu.
Sabela LensLiver Unit, Hospital Clinic, IDIBAPS and CIBERehd, University of Barcelona, Barcelona, Spain.
Stuart McPhersonLiver Unit, The Newcastle upon Tyne Hospitals NHS Foundation and Trust and Newcastle University, Newcastle upon Tyne, UK.
Magdy ElkhashabToronto Liver Centre, Toronto, Canada.
Victor Ankoma-SeyDivision of Gastroenterology, Sherri and Alan Conover Center for Liver Disease and Transplantation, Houston Methodist, Houston, TX, USA.
Mark BondinAbbVie, Inc., North Chicago, IL, USA.
Ana Gabriela Pires Dos SantosAbbVie, Inc., North Chicago, IL, USA.
Zhenyi XueAbbVie, Inc., North Chicago, IL, USA.
Roger TrinhAbbVie, Inc., North Chicago, IL, USA.
Ariel PorcallaAbbVie, Inc., North Chicago, IL, USA.
Stefan ZeuzemJ.W. Goethe University, Frankfurt, Germany.
AbbVie (United States) · USGoethe University Frankfurt · DEHouston Methodist · USNewcastle upon Tyne Hospitals NHS Foundation Trust · GBToronto Liver Centre · CAUniversitat de Barcelona · ESUniversity of Michigan–Ann Arbor · US

Funding

AbbVie (US) AbbVie (US)
6 · The paper itself

Abstract

introductionThe presence or absence of cirrhosis in patients with chronic hepatitis C virus (HCV) infection influences the type and duration of antiviral therapy. Non-invasive markers, like serum aspartate aminotransferase (AST) to platelet ratio index (APRI), may help identify appropriate HCV treatment-naive patients for 8-week treatment with the pangenotypic regimen of glecaprevir/pibrentasvir.

methodsThis single-arm, open-label, international, prospective study (NCT03212521) evaluated the efficacy and safety of 8-week glecaprevir/pibrentasvir regimen in HCV treatment-naïve adults with chronic HCV genotypes 1-6 infection, APRI ≤ 1, and no prior evidence of cirrhosis. The primary and secondary outcomes were sustained virologic response at 12 weeks post-treatment (SVR12) by modified intent-to-treat (mITT) and intent-to-treat (ITT) analyses, respectively. Additional endpoints included virologic failures, treatment adherence, and genotype-specific SVR12 rates.

resultsAmong the 230 patients enrolled, most were less than 65 years old (90%); 37% and 43% had a history of injection drug use or psychiatric disorders, respectively. SVR12 rates were 100% (222/222; 95% CI 98.3-100%) and 96.5% (222/230; 95% CI 94.2-98.9%) by mITT and ITT analyses, respectively. There were no virologic failures. ITT SVR12 rates were greater than 94% for all HCV genotypes. In patients with available data, treatment adherence was 99% (202/204). There were no grade 3 or higher laboratory abnormalities in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, and low rates of serious adverse events (2%).

conclusionsGlecaprevir/pibrentasvir was highly efficacious and well tolerated in HCV treatment-naïve patients with APRI ≤ 1 and no prior evidence of cirrhosis.

trial registrationClinicalTrials.gov number, NCT03212521.

fundingAbbVie. Plain language summary available for this article.

Indexed as

AdultAgedAged, 80 and overAminoisobutyric AcidsAntiviral AgentsBenzimidazolesComorbidityCyclopropanesFemaleGenotypeHepacivirusHepatitis C, ChronicHumansLactams, MacrocyclicLeucineLiver CirrhosisAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidesChronic hepatitis CDirect acting antiviralGlecaprevir/pibrentasvirInfectious diseasesSimplification

Identifiers

PMID31646465
PMCPMC6860464
OpenAlexW2982028489

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.