Evidence map›Paper›PMID 31568620›Full record

ArticleLiver international : official journal of the International Association for the Study of the Liver2020

Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.

Ashley Brown, Tania M Welzel, Brian Conway, Francesco Negro, Norbert Bräu, Jason Grebely, Massimo Puoti, Alessio Aghemo, Henning Kleine, David Pugatch and 5 more

8 registry-linked trialsAbstract read
In one paragraph

Article in Liver international : official journal of the International Association for the Study of the Liver, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–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.

NCT02243293 phase2 / phase3completednot on this map

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)

TypeinterventionalSponsorAbbVieRan2014 to 2017Enrolled694ConditionsChronic Hepatitis C, Hepatitis C VirusArmsABT-493, ABT-530, ribavirin (RBV), ABT-493/ABT-530
NCT02446717 phase2 / phase3completednot on this map

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled141ConditionsChronic Hepatitis C, Hepatitis C Virus, HCV, Direct-Acting Antiviral Agent (DAA)-ExperiencedArmsABT-493, ABT-530, ribavirin (RBV), ABT-493/ABT-530
NCT02604017 phase3completednot on this map

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled703ConditionsChronic Hepatitis C, Hepatitis C Virus, HCVArmsABT-493/ABT-530
NCT02636595 phase3completednot on this map

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled121ConditionsHepatitis C VirusArmsABT-493/ABT-530
NCT02640157 phase3completednot on this map

A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled506ConditionsChronic Hepatitis C, Hepatitis C Virus, Genotype 3 Hepatitis C VirusArmsABT-493/ABT-530, Sofosbuvir, Daclatasvir
NCT02640482 phase3completednot on this map

A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled304ConditionsChronic Hepatitis C Virus (HCV) InfectionArmsABT-493/ABT-530, Placebo for ABT-493/ABT-530
NCT02642432 phase3completednot on this map

A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled146ConditionsHepatitis C Virus Infection, Chronic Hepatitis C, Compensated CirrhosisArmsABT-493/ABT-530
NCT02651194 phase3completednot on this map

A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled104ConditionsChronic Hepatitis C Virus (HCV) InfectionArmsABT-493/ABT-530
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  9. Article
  10. Article
  11. Outcomes of the CT2 study: A 'one-stop-shop' for community-based hepatitis C testing and treatment in Yangon, Myanmar.Liver international : official journal of the International Association for the Study of the Liver · 2021
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.Liver international : official journal of the International Association for the Study of the Liver · 2020
    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

15 authors.

Ashley BrownImperial College Healthcare NHS Trust, London, UK.
Tania M WelzelDepartment of Medicine 1, J. W. Goethe University Hospital, Frankfurt am Main, Germany.
Brian ConwayVancouver Infectious Diseases Center, Vancouver, BC, Canada.
Francesco NegroDivisions of Gastroenterology and Hepatology and Clinical Pathology, Geneva University Hospital, Geneva, Switzerland.ORCID 0000-0003-4046-4806
Norbert BräuJames J. Peters VA Medical Center, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
Jason GrebelyThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Massimo PuotiDepartment of Infectious Diseases, AO Ospedale Niguarda Ca' Granda, Milan, Italy.
Alessio AghemoHumanitas University and Clinical and Research Hospital, Rozzano, Italy.
Henning KleineAbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany.
David PugatchAbbVie, North Chicago, IL, USA.
Federico J MensaAbbVie, North Chicago, IL, USA.
Yaozhu J ChenAbbVie, North Chicago, IL, USA.
Yang LeiAbbVie, North Chicago, IL, USA.
Eric LawitzTexas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.
Tarik AsselahDepartment of Hepatology, Centre de Recherche sur l'Inflammation (CRI), INSERM UMR 1149, University of Paris Diderot, AP-HP Hôpital Beaujon, Clichy, France.ORCID 0000-0002-0024-0595

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsAdequate adherence to hepatitis C virus (HCV) treatment is believed to be a key component of treatment success because non-adherence can potentially result in treatment failure and the emergence of resistant viral variants. This analysis assessed factors associated with non-adherence to glecaprevir/pibrentasvir (G/P) therapy and the impact of non-adherence on sustained virological response at post-treatment week 12 (SVR12) rates in HCV genotype (GT) 1-6-infected patients.

methodsAdherence was calculated by pill counts at study visits during treatment, and defined as having a lowest treatment adherence of ≥80% and ≤120% at each study visit. Exploratory logistic regression modelling assessed predictors of non-adherence to G/P therapy. SVR12 rates by treatment adherence were assessed in the intent-to-treat (ITT) population and modified ITT (mITT) population, which excludes non-virological failures.

resultsOverall, 97% (2024/2091) of patients were adherent to G/P therapy at all consecutive study visits. Alcohol use was the only baseline characteristic independently associated with non-adherence to G/P therapy (OR: 2.38; 95% CI: 1.13-5.01; P = .022). In the mITT population, overall SVR12 rates were high both in patients who were adherent to G/P therapy and those who were not (99% [1983/2008] and 95% [58/61] respectively; P = .047). Corresponding SVR12 rates in the ITT population were 98% (1983/2024) and 87% (58/67) respectively.

conclusionsMost patients adhered to G/P therapy. SVR12 rates were high both in patients who were adherent to G/P treatment and those who were not. Patient education on treatment adherence should remain an important part of HCV treatment. CLINICAL TRIALS REGISTRATION: NCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194, NCT02243293, NCT02446717.

Indexed as

Hepatitis CHepatitis C, ChronicAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesGenotypeHepacivirusHumansLactams, MacrocyclicLeucineProlinePyrrolidinesQuinoxalinesSulfonamidesAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidesadherenceglecaprevirG/Phepatitis C viruspibrentasvir

Identifiers

PMID31568620
PMCPMC7187170

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 2 more above

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.