Evidence map›Paper›PMID 29851265›Full record

ArticleJournal of viral hepatitis2018

Real-world effectiveness of elbasvir/grazoprevir In HCV-infected patients in the US veterans affairs healthcare system.

J R Kramer, A Puenpatom, K F Erickson, Y Cao, D Smith, H B El-Serag, F Kanwal

Abstract read
In one paragraph

Article in Journal of viral hepatitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

7 authors.

J R KramerCenter for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, USA.ORCID 0000-0003-2953-4949
A PuenpatomMerck & Co., Inc., Kenilworth, NJ, USA.
K F EricksonCenter for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, USA.
Y CaoCenter for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, USA.
D SmithCenter for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, USA.
H B El-SeragCenter for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, USA.
F KanwalCenter for Innovations in Quality, Effectiveness, and Safety (IQuESt), Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, USA.

Funding

Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Geoffrey A Preidis · 2001 to 2026
$28.3M
TRAINING PROGRAM IN ACADEMIC NEPHROLOGYT32DK007357 · NIDDK · STANFORD UNIVERSITY · PI CHERTOW, GLENN MATTHEW · 1986 to 2022
$4.8M
Research Training in GastroenterologyT32DK083266 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Hashem B El-Serag, FASIHA KANWAL · 2010 to 2026
$2.3M
Mentoring Patient-Oriented Clinical Investigators in NephrologyK24DK085446 · NIDDK · STANFORD UNIVERSITY · PI CHERTOW, GLENN MATTHEW · 2010 to 2022
$1.4M
Care for Women Veterans with Hepatitis C Virus InfectionI01HX001285 · VA · MICHAEL E DEBAKEY VA MEDICAL CENTER · PI KANWAL, FASIHA · 2014 to 2014
–
Center for Innovations in Quality, Effectiveness, and Safety (IQuESt)I50HX001236 · VA · MICHAEL E DEBAKEY VA MEDICAL CENTER · PI LAURA A PETERSEN · 2015 to 2026
–
HSRD VA I01 HX001285HSRD VA I50 HX001236Merck & & Co., Inc., Kenilworth, NJNIDDK NIH HHS K24 DK085446NIDDK NIH HHS P30 DK056338NIDDK NIH HHS P30 DK56338NIDDK NIH HHS T32 DK007357NIDDK NIH HHS T32 DK083266NIH HHS T32 DK083266-01A1Office of Research and Development Service VA IIR 13-059VAVeterans Health Administration
6 · The paper itself

Abstract

Elbasvir/grazoprevir (EBR/GZR) is an all-oral direct-acting antiviral agent (DAA) with high sustained virologic response (SVR) in clinical trials. This study's primary objective was to evaluate effectiveness of EBR/GZR among HCV-infected patients in a real-world clinical setting. We conducted a nationwide retrospective observational cohort study of HCV-infected patients in the US Department of Veterans Affairs (VA) using the VA Corporate Data Warehouse. The study population included patients with positive HCV RNA who initiated EBR/GZR from February 1 to August 1, 2016. We calculated the 95% confidence interval for binomial proportions for SVR overall and by demographic subgroups. Clinical and demographic characteristics were also evaluated. We included 2436 patients in the study cohort. Most were male (96.5%), African American (57.5%), with mean age of 63.5 (SD = 5.9) and 95.4% infected with genotype (GT) 1 [GT1a (34.7%), GT1b (58.6%)]. Other comorbidities included diabetes (53.2%), depression (57.2%) and HIV (3.0%). More than 50% had history of drug or alcohol abuse (53.9% and 60.5%, respectively). 33.2% of the cohort had cirrhosis. A total of 95.6% (2,328/2,436; 95% CI: 94.7%-96.4%) achieved SVR. The SVR rates by subgroups were: male, 95.5% (2245/2350); female, 96.5% (83/86); GT1a, 93.4%, GT1b, 96.6%, GT4, 96.9%, African American, 95.9% (1,342/1,400); treatment-experienced, 96.3% (310/322); cirrhosis, 95.6% (732/766); stage 4-5 CKD, 96.3% (392/407); and HIV, 98.6% (73/74). SVR rates were high overall and across patient subgroups regardless of gender, race/ethnicity, cirrhosis, renal impairment or HIV. This study provided important data regarding the effectiveness of EBR/GZR in a large clinical setting.

Indexed as

AgedAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropanesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis CHumansImidazolesLactams, MacrocyclicMaleMiddle AgedAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropaneselbasvirgrazoprevirImidazolesLactams, MacrocyclicQuinoxalinesSulfonamidesdirect-acting antiviral agentshepatitis C virustreatment effectivenessveterans affairs

Identifiers

PMID29851265
PMCPMC6202183

What OpenQuestion holds

Textmetadata
LicenceTDM
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.