Evidence map›Paper›PMID 34448313›Full record

Trial reportJournal of viral hepatitis2021

Positive predictive value of sustained virologic response 4 weeks posttreatment for achieving sustained virologic response 12 weeks posttreatment in patients receiving glecaprevir/pibrentasvir in Phase 2 and 3 clinical trials.

Edward Gane, Victor de Ledinghen, Douglas E Dylla, Giuliano Rizzardini, Mitchell L Shiffman, Stephen T Barclay, Jose Luis Calleja, Zhenyi Xue, Margaret Burroughs, Julio A Gutierrez

Open access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Journal of viral hepatitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 11% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Unsuccessful Direct Acting Antiviral Hepatitis C Treatment Among People With HIV: Findings From an International Cohort.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Article
  12. Observational
  13. Article
  14. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  15. Article
  16. Article
  17. Article
  18. 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

10 authors at 8 institutions in 6 countries.

Edward GaneFaculty of Medicine, University of Auckland, Auckland, New Zealand.ORCID 0000-0003-4086-7955
Victor de LedinghenCentre d'Investigation de la Fibrose Hépatique, Bordeaux University Hospital, Pessac, France.ORCID 0000-0001-6414-1951
Douglas E DyllaAbbVie Inc, North Chicago, Illinois, USA.
Giuliano Rizzardini1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.
Mitchell L ShiffmanLiver Institute of Virginia, Bon Secours Mercy Health, Richmond, Virginia, USA.
Stephen T BarclayDepartment of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.
Jose Luis CallejaDepartment of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Madrid, Spain.ORCID 0000-0002-2265-6591
Zhenyi XueAbbVie Inc, North Chicago, Illinois, USA.
Margaret BurroughsAbbVie Inc, North Chicago, Illinois, USA.
Julio A GutierrezScripps Center for Organ and Cell Transplantation, La Jolla, California, USA.
AbbVie (United States) · USASST Fatebenefratelli Sacco · ITBon Secours Mercy Health · USGlasgow Royal Infirmary · GBHospital Universitario Puerta de Hierro Majadahonda · ESInserm · FRScripps Health · USUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sustained virologic response at posttreatment Week 12 (SVR12) is the widely accepted efficacy endpoint for direct-acting antiviral agents. Those with hepatitis C virus (HCV) are presenting younger with milder liver disease, potentially reducing need for long-term liver posttreatment monitoring. This analysis aimed to determine the positive predictive value (PPV) of SVR at posttreatment Week 4 (SVR4) for achieving SVR12 in patients with HCV, without cirrhosis or with compensated cirrhosis, receiving glecaprevir/pibrentasvir (G/P) in clinical trials. An integrated dataset from 20 Phase 2 and 3 clinical trials of G/P was evaluated in patients with 8-, 12- or 16-week treatment duration consistent with the current label (label-consistent group), and in all patients regardless of treatment duration consistency with the current label (overall group). Sensitivity analyses handled missing data either by backward imputation or were excluded. SVR4 PPV, negative predictive value (NPV), sensitivity and specificity were calculated for achieving SVR12 in both groups, and by treatment duration in the label-consistent group. SVR was defined as HCV ribonucleic acid <lower limit of quantification. The label-consistent group and overall group included 2890 and 4390 patients, respectively. PPV of SVR4 for SVR12 was >99% in both groups regardless of treatment duration. Not achieving SVR4 had 100% NPV and sensitivity for all groups. SVR4 measure had 79.5% specificity for identifying patients who did not achieve SVR12. Across 20 Phase 2/3 clinical trials of G/P, SVR4 was highly predictive of SVR12. Long-term follow-up to confirm SVR may not be necessary for certain populations of patients with HCV.

Indexed as

Antiviral AgentsHepatitis C, ChronicAminoisobutyric AcidsBenzimidazolesCyclopropanesGenotypeHepacivirusHumansLactams, MacrocyclicLeucinePredictive Value of TestsProlinePyrrolidinesQuinoxalinesSulfonamidesSustained Virologic ResponseAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidescare cascadeconcordancedirect-acting antiviralshepatitis C virussustained virologic response

Identifiers

PMID34448313
PMCPMC9292745
OpenAlexW3195766466

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.