Evidence map›Paper›PMID 32406487›Full record

Trial reportThe Journal of infectious diseases2020

Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune Activation.

Donald D Anthony, Mark S Sulkowski, Laura M Smeaton, Sofi Damjanovska, Carey L Shive, Corinne M Kowal, Daniel E Cohen, Debika Bhattacharya, Beverly L Alston-Smith, Ashwin Balagopal and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The Journal of infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02194998 (Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT02194998 phase2terminatednot on this map

Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2015 to 2018Enrolled46ConditionsHIV Infections, Hepatitis CArmsParitaprevir/ritonavir/ombitasvir (PTV/r/OBT), Dasabuvir (DSV), Ribavirin (RBV)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
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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

11 authors at 8 institutions in 1 country.

Donald D AnthonyDepartments of Medicine and Pathology, VA Medical Center and MetroHealth Medical Center, Case Western Reserve University, ACTG Immunology Support Laboratory, Cleveland Ohio, USA.
Mark S SulkowskiJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Laura M SmeatonHarvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Sofi DamjanovskaDepartments of Medicine and Pathology, VA Medical Center and MetroHealth Medical Center, Case Western Reserve University, ACTG Immunology Support Laboratory, Cleveland Ohio, USA.
Carey L ShiveDepartments of Medicine and Pathology, VA Medical Center and MetroHealth Medical Center, Case Western Reserve University, ACTG Immunology Support Laboratory, Cleveland Ohio, USA.
Corinne M KowalDepartments of Medicine and Pathology, VA Medical Center and MetroHealth Medical Center, Case Western Reserve University, ACTG Immunology Support Laboratory, Cleveland Ohio, USA.
Daniel E CohenAbbVie Inc, North Chicago, Illinois, USA.
Debika BhattacharyaDivision of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Beverly L Alston-SmithDivision of AIDS, National Institutes of Health, Bethesda, Maryland, USA.
Ashwin BalagopalJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
David L WylesUniversity of Colorado School of Medicine, Denver, Colorado, USA.
MetroHealth Medical Center · USJohns Hopkins Medicine · USAbbVie (United States) · USCase Western Reserve University · USHarvard University · USNational Institutes of Health · USUniversity of California, Los Angeles · USUniversity of Colorado Denver · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
Spatial Models of Intrahepatic Hepatitis C Virus Propagation in HumansR01AI116868 · NIAID · TRIAD NATIONAL SECURITY, LLC · PI ASHWIN BALAGOPAL, Ruy M Ribeiro · 2016 to 2026
$8.5M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
Role of NK cells in control of HCV infection associated hepatocellular carcinomaI01BX001894 · VA · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · PI Donald D Anthony · 2013 to 2026
–
Impact of Immune Activation on Cardiovascular and Immune Health in RAI01CX001791 · VA · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · PI ANTHONY, DONALD D · 2020 to 2024
–
BLRD VA I01 BX001894CSRD VA IK2 CX001471NIAID NIH HHS R01 AI116868NIAID NIH HHS U01 AI068634NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI106701NIDA NIH HHS K24 DA034621
6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) direct-acting antivirals are highly effective. Less is known about changes in markers of immune activation in persons with human immunodeficiency virus (HIV) in whom a sustained virologic response (SVR) is achieved.

methodsWe conducted a nonrandomized clinical trial of 12 or 24 weeks of paritaprevir-ritonavir-ombitasvir plus dasabuvir (PrOD) with or without ribavirin in persons with HCV-1/HIV coinfection suppressed with antiretroviral therapy. Plasma HCV, soluble CD14 (sCD14), interferon-inducible protein 10, soluble CD163 (sCD163), interleukin 6 (IL-6), interleukin 18, monocyte chemoattractant protein (MCP-1), autotaxin (ATX), and Mac2-binding protein (Mac2BP) were measured over 48 weeks.

resultsParticipants were treated with PrOD for 12 (n = 9) or 24 (n = 36) weeks; the SVR rate at 12 weeks was 93%. At baseline, cirrhosis was associated with higher ATX and MCP-1, female sex with higher ATX and IL-6, older age with higher Mac2BP, higher body mass index with higher ATX, and HIV-1 protease inhibitor use with higher sCD14 levels. In those with SVR, interferon-inducible protein 10, ATX, and Mac2BP levels declined by week 2, interleukin 18 levels declined by the end of treatment, sCD14 levels did not change, and sCD163, MCP-1, and IL-6 levels changed at a single time point.

conclusionsDuring HIV/HCV coinfection, plasma immune activation marker heterogeneity is in part attributable to age, sex, cirrhosis, body mass index, and/or type of antiretroviral therapy. HCV treatment with paritaprevir-ritonavir-ombitasvir plus dasabuvir is highly effective and is associated with variable rate and magnitude of decline in markers of immune activation. CLINICAL TRIALS REGISTRATION: NCT02194998.

Indexed as

2-NaphthylamineAdultAnilidesAnti-HIV AgentsAntiviral AgentsBiomarkersCarbamatesCoinfectionCyclopropanesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHIV-1HIV Infections2-NaphthylamineAnilidesAnti-HIV AgentsAntiviral AgentsBiomarkersCarbamatesCyclopropanesdasabuvirImmunologic FactorsLactams, MacrocyclicombitasvirparitaprevirProlineRibavirinRitonavirSulfonamidesUracilValineDAA therapyhepatitis Chumanimmunityinflammation

Identifiers

PMID32406487
PMCPMC7749191
OpenAlexW3025822722

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.