Evidence map›Paper›PMID 34255381›Full record

Trial reportHepatology (Baltimore, Md.)2021

A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study.

Mark S Sulkowski, Juhi S Moon, Kenneth E Sherman, Giuseppe Morelli, Jama M Darling, Andrew J Muir, Mandana Khalili, Dawn A Fishbein, Federico Hinestrosa, Mitchell L Shiffman and 18 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02786537 (THE PRIORITIZE STUDY), which is not on this 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
0.9field-weighted citation impact, top 25% 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.

NCT02786537 phase4completednot on this map

THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders

TypeinterventionalSponsorUniversity of FloridaRan2016 to 2020Enrolled1,275ConditionsChronic Hepatitis CArmsSOF/LDV (sofosbuvir/ledipasvir), PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only), EBR/GZR (elbasvir/grazoprevir), Ribavirin
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

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

28 authors at 13 institutions in 1 country.

Mark S SulkowskiDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-2145-6352
Juhi S MoonDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD.
Kenneth E ShermanDepartment of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.ORCID 0000-0002-0560-0019
Giuseppe MorelliDepartment of Gastroenterology, Hepatology & Nutrition, University of Florida, Gainesville, FL.
Jama M DarlingDivision of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Andrew J MuirDivision of Gastroenterology, Duke University, Durham, NC.ORCID 0000-0002-0206-1179
Mandana KhaliliDepartment of Medicine, University of California San Francisco, Zuckerberg San Francisco General, Hospital and Trauma Center, San Francisco, CA.ORCID 0000-0001-9178-9139
Dawn A FishbeinInfectious Disease, Medstar Health Research Institute, Washington, DC.
Federico HinestrosaInfectious Disease, Orlando Immunology Center, Orlando, FL.
Mitchell L ShiffmanDepartment of Gastroenterology, Liver Institute of Virginia, Richmond, VA.
Adrian Di BisceglieDepartment of Internal Medicine, Saint Louis University School of Medicine, St. Louis, MO.
K Rajender ReddyDepartment of Medicine, University of Pennsylvania, Philadelphia, PA.
Brian PearlmanDepartment of Internal Medicine, Wellstar Health System, Atlanta, GA.
Anna S LokDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI.
Michael W FriedDivision of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Paul W StewartDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Joy PeterDepartment of Gastroenterology, Hepatology & Nutrition, University of Florida, Gainesville, FL.
Summer WadsworthPRIORITIZE Patient Engagement Group consultant, Garner, NC.
Scott KixmillerPRIORITIZE Patient Engagement Group consultant, Greensboro, NC.
Anquenette SloanPRIORITIZE Patient Engagement Group consultant, Pittsboro, NC.
Monika VainoriusDivision of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Patrick M HorneDepartment of Gastroenterology, Hepatology & Nutrition, University of Florida, Gainesville, FL.
Larry MichaelDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Meichen DongDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Donna M EvonDivision of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Jodi B SegalDivision of Internal Medicne, Johns Hopkins University School of Medicine, Baltimore, MD.
David R NelsonDepartment of Gastroenterology, Hepatology & Nutrition, University of Florida, Gainesville, FL.
PRIORITIZE Study Team
University of North Carolina at Chapel Hill · USUniversity of Florida · USJohns Hopkins University · USBon Secours Liver Institute of Richmond · USDuke University · USMedStar Health · USOrlando Immunology Center · USSaint Louis University · USSan Francisco General Hospital · USUniversity of Cincinnati Medical Center · USUniversity of Michigan · USUniversity of Pennsylvania · USWellStar Health System · US

Funding

Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
Mentoring Multidisciplinary Patient-Oriented Research in Viral HepatitisK24AA022523 · NIAAA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KHALILI, MANDANA · 2013 to 2023
$1.9M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NCATS NIH HHS UL1 TR001409NIAAA NIH HHS K24 AA022523NIDA NIH HHS K24 DA034621
6 · The paper itself

Abstract

BACKGROUND AND

aimsMultiple direct-acting antiviral (DAA) regimens are available to treat HCV genotype 1 infection. However, comparative effectiveness from randomized controlled trials of DAA regimens is unavailable. APPROACH AND

resultsWe conducted a pragmatic randomized controlled trial (NCT02786537) to compare the effectiveness of DAAs for HCV genotype 1a or 1b on viral response, safety, tolerability, and medication nonadherence. Adults with compensated liver disease, HCV genotype 1, not pregnant or breastfeeding, and with health insurance likely to cover ledipasvir/sofosbuvir (LDV/SOF) were recruited from 34 US viral hepatitis clinics. Participants were randomized (± ribavirin) to LDV/SOF, elbasvir/grazoprevir (EBR/GZR), and paritaprevir/ritonavir/ombitasvir+dasabuvir (PrOD; treatment arm stopped early). Primary outcomes included sustained viral response at 12 weeks (SVR12), clinician-recorded adverse events, patient-reported symptoms, and medication nonadherence. Between June 2016 and March 2018, 1,609 participants were randomized. Among 1,128 participants who received ≥1 dose of EBR/GZR or LDV/SOF (± ribavirin), SVR12 was 95.2% (95% CI, 92.8%-97.6%) and 97.4% (95% CI, 95.5%-99.2%), respectively, with a difference estimate of 2.2% (-0.5% to 4.7%), falling within the "equivalence" interval (-5% to 5%). While most (56%) participants experienced adverse events, few were serious (4.2%) or severe (1.8%). In the absence of ribavirin, discontinuations due to adverse events were rare. Patient-reported symptoms and medication nonadherence were similar. Study limitations were dropout due to insurance denial and loss to follow-up after treatment, limiting the ability to measure SVR12.

conclusionsThis pragmatic trial demonstrated high SVR12 for participants treated with EBR/GZR and LDV/SOF with few adverse effects. Overall, the two regimens were equivalent in effectiveness. The results support current HCV guidelines that do not distinguish between ribavirin-free EBR/GZR and LDV/SOF.

Indexed as

2-NaphthylamineAdministration, OralAdolescentAdultAgedAged, 80 and overAnilidesAntiviral AgentsBenzimidazolesBenzofuransCyclopropanesDrug CombinationsDrug Therapy, CombinationFemaleFluorenesFollow-Up Studies2-NaphthylamineAnilidesAntiviral AgentsBenzimidazolesBenzofuransCyclopropanesdasabuvirDrug Combinationselbasvir-grazoprevir drug combinationFluorenesImidazolesLactams, Macrocyclicledipasvir, sofosbuvir drug combinationombitasvirparitaprevirProlineQuinoxalinesRibavirinRNA, ViralSofosbuvirSulfonamidesUracilValine

Identifiers

PMID34255381
PMCPMC8639765
OpenAlexW3177821447

What OpenQuestion holds

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Registered trials

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.