Evidence map›Paper›PMID 32445613›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2020

Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies.

Betty B Yao, Linda M Fredrick, Gretja Schnell, Kris V Kowdley, Paul Y Kwo, Fred Poordad, Kinh Nguyen, Samuel S Lee, Christophe George, Florence Wong and 8 more

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

Trial report 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. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 40% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Trial
  2. Review
  3. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  4. Frontiers in microbiology · 2024
    Article
  5. Review
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

18 authors at 14 institutions in 7 countries.

Betty B YaoAbbVie Inc, North Chicago, IL, USA.
Linda M FredrickAbbVie Inc, North Chicago, IL, USA.
Gretja SchnellAbbVie Inc, North Chicago, IL, USA.
Kris V KowdleyElson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.
Paul Y KwoStanford University School of Medicine, Palo Alto, CA, USA.
Fred PoordadThe Texas Liver Institute, University of Texas Health, San Antonio, TX, USA.
Kinh NguyenNational Hospital for Tropical Diseases, Hanoi, Vietnam.
Samuel S LeeUniversity of Calgary, Calgary, AB, Canada.
Christophe GeorgeAZ Groeninge Campus Kennedylaan, Kortrijk, Belgium.
Florence WongToronto General Hospital, University of Toronto, Toronto, ON, Canada.ORCID 0000-0001-9263-8869
Edward GaneAuckland Clinical Studies, Auckland, New Zealand.ORCID 0000-0003-4086-7955
Armand AbergelCentre Hospitalier Universitaire Estaing, Clermont Ferrand, France.
Catherine W SpearmanDivision of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.
Tuan NguyenAlvarado Hospital Medical Center, San Diego, CA, USA.
Manh Hung LeHospital for Tropical Diseases, Ho Chi Minh, Vietnam.
Thuy Tt PhamHoa Hao Medic Company Ltd, Ho Chi Minh, Vietnam.
Federico MensaAbbVie Inc, North Chicago, IL, USA.
Tarik AsselahDepartment of Hepatology, Centre de Recherche sur l'Inflammation, INSERM UMR 1149, Université Paris Diderot, AP-HP Hôpital Beaujon, Clichy, France.ORCID 0000-0002-0024-0595
AbbVie (United States) · USHospital for Tropical Diseases · VNAuckland Institute of Studies · NZAZ Groeninge · BECentre Hospitalier Universitaire de Clermont-Ferrand · FRHoa Sen University · VNInserm · FRPalo Alto University · USPomerado Hospital · USThe University of Texas Health Science Center at San Antonio · USUniversity of Calgary · CAUniversity of Cape Town · ZAUniversity of Toronto · CAWashington State University Spokane · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsHepatitis C virus (HCV) has high genetic diversity with six major genotypes (GT) GT1-6 and global distribution. HCV GT5 and 6 are rare with < 10 million people infected worldwide. Data on direct-acting antiviral use in these rare HCV genotypes are limited. The study aimed to evaluate the efficacy and safety of glecaprevir/pibrentasvir (G/P) in a pooled analysis of phase 2/3 trials in HCV GT5 or 6-infected patients without cirrhosis or with compensated cirrhosis.

methodsPatients with chronic HCV GT5 or 6 infection received oral G/P (300 mg/120 mg) once daily for 8 or 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (SVR12) in the intention-to-treat population.

resultsOne hundred eighty-one patients were evaluated; 56 with HCV GT5 and 125 with HCV GT6. The majority were treatment-naïve (88%) and non-cirrhotic (85%). Overall SVR12 rate with 8- or 12-week G/P treatment was 98% (178/181). Eight-week treatment with G/P yielded SVR12 rates of 95% (21/22) in HCV GT5- and 99% (69/70) in HCV GT6-infected non-cirrhotic patients. Eight- and 12-week treatment of patients with compensated cirrhosis achieved SVR12 rates of 100% (10/10) and 94% (17/18) respectively. The G/P regimen was well-tolerated; 3% (6/181) Grade 3 or higher adverse events, and no serious adverse events were attributed to G/P or led to study drug discontinuation.

conclusionsThis integrated dataset demonstrates a high SVR12 rate following 8-week G/P treatment in patients with HCV GT5 (96%) or GT6 (99%) infection without cirrhosis or with compensated cirrhosis.

Indexed as

Hepatitis CHepatitis C, ChronicAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesGenotypeHepacivirusHumansLactams, MacrocyclicLeucineProlinePyrrolidinesQuinoxalinesSulfonamidesSustained Virologic ResponseAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamidesgenotype 5genotype 6glecaprevir and pibrentasvirhepatitis Cintegrated analysisphase 2 and 3

Identifiers

PMID32445613
PMCPMC7539968
OpenAlexW3027487087

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.