Evidence map›Paper›PMID 31862503›Full record

ArticleAntiviral research2020

Effectiveness of Elbasvir/Grazoprevir in patients with hepatitis C virus genotype 1 infection and chronic kidney disease in the United States veterans population.

Debra T Choi, Amy Puenpatom, Xian Yu, Kevin F Erickson, Fasiha Kanwal, Hashem B El-Serag, Jennifer R Kramer

Open access · greenAbstract read
In one paragraph

Article in Antiviral research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  4. Review
  5. 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

7 authors at 4 institutions in 1 country.

Debra T ChoiCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Amy PuenpatomMerck & Co., Inc., Kenilworth, NJ, USA.
Xian YuCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Kevin F EricksonCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Fasiha KanwalCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Hashem B El-SeragCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Jennifer R KramerCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX, USA. Electronic address: jkramer@bcm.edu.
Center for Innovation · USMichael E. DeBakey VA Medical Center · USBaylor College of Medicine · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI James Versalovic · 2001 to 2026
$28.3M
Research Training in GastroenterologyT32DK083266 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Hashem B El-Serag, FASIHA KANWAL · 2010 to 2026
$2.3M
HSRD VA I01 HX001285HSRD VA I50 HX001236NIDDK NIH HHS P30 DK056338NIDDK NIH HHS T32 DK083266
6 · The paper itself

Abstract

BACKGROUND &

aimsRandomized controlled trials of EBR/GZR have reported high treatment efficacy, safety and tolerability in patients undergoing dialysis. However, real world effectiveness data for EBR/GZR in this population is lacking. We evaluated the effectiveness of EBR/GZR in an HCV-infected population with all stages of CKD including dialysis compared with control patients with estimated glomerular filtration rate (eGFR) ≥60 in the US Department of Veterans Affairs (VA).

methodsWe conducted a retrospective cohort study of patients with chronic HCV genotype 1 infection with EBR/GZR prescriptions dispensed during February 1, 2016-August 31, 2017 in 128 VA Medical Centers. We collected patient information regarding history of dialysis, end stage renal disease (ESRD), and/or eGFR values. We measured SVR based on undetectable HCV RNA at least 4 weeks after the completion of treatment. We examined SVR rates by CKD stage compared to control patients and within patient subgroups using logistic regression models.

resultsWe identified 5961 patients (42.5% genotype 1a, 55.0% genotype 1b) who met eligibility criteria and completed a EBR/GZR treatment course (≥11 weeks). Approximately 73.2% (n = 4361) had eGFR ≥60 who served as control patients, 14.4% (n = 860) had Stage 3 CKD, and 12.4% (n = 740) had Stage 4-5 CKD or ESRD. Of patients with Stage 4-5 CKD/ESRD, 76.1% underwent dialysis (n = 563). The overall SVR was 96.7% in all patients, 96.4% for eGFR≥60, 98.3% in Stage 3 CKD, and 96.5% in Stage 4-5 CKD/ESRD. No statistically significant differences were found in the SVR rates in patients with or without dialysis in the Stage 4-5 CKD/ESRD patients (adjusted OR 0.91; 95% CI 0.56-1.47 and OR 1.74; 95% CI 0.63-4.81) compared with those with eGFR≥60.

conclusionWe found EBR/GZR was effective in patients with HCV GT1 infection regardless of CKD severity or receipt of dialysis in the US VA population.

Indexed as

AdolescentAdultAgedAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropanesDrug Therapy, CombinationElectronic Health RecordsFemaleGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropaneselbasvirgrazoprevirImidazolesLactams, MacrocyclicQuinoxalinesSulfonamidesChronic kidney diseaseDialysisEffectiveness of HCV treatmentHCV treatment

Identifiers

PMID31862503
PMCPMC8724917
OpenAlexW2995422882

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.