Evidence map›Paper›PMID 40019678›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025

Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life.

Thiago S Torres, Pooja T Saha, Laura Smeaton, Chanelle Wimbish, Dimas Alexandre Kliemann, Anchalee Avihingsanon, Cissy Kityo, Jaclyn Ann Bennet, Marije Van Schalkwyk, Benjamin Linas and 7 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03512210 (A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection), which is not on this map. Cited by 1 paper.

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

NCT03512210 phase4completednot on this map

A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Study

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2018 to 2021Enrolled400ConditionsHepatitis C, HIV-1-infection, Liver DiseasesArmsSofosbuvir/Velpatasvir (SOF/VEL), Minimal Monitoring (MINMON) Strategy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

17 authors.

Thiago S TorresInstituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil 4365 Manguinhos, Rio de Janeiro, RJ, 21040-360, Brazil. thiago.torres@ini.fiocruz.br.ORCID http://orcid.org/0000-0002-2557-601X
Pooja T SahaCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA, USA.ORCID http://orcid.org/0000-0002-2317-6311
Laura SmeatonCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA, USA.ORCID http://orcid.org/0000-0001-7243-4703
Chanelle WimbishDLH Corporation, Bethesda, MD, USA.ORCID http://orcid.org/0009-0006-0019-2366
Dimas Alexandre KliemannHospital Nossa Senhora da Conceicao, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.ORCID http://orcid.org/0000-0003-4326-0024
Anchalee AvihingsanonThai Red Cross AIDS Research Center, Center of Excellence in Tuberculosis, Faculty of Medicine, HIV-NAT, Chulalongkorn University, Bangkok, Thailand.ORCID http://orcid.org/0000-0003-3222-9611
Cissy KityoJoint Clinical Research Centre, Kampala, Uganda.ORCID http://orcid.org/0000-0002-9286-7052
Jaclyn Ann BennetClinical HIV Research Unit, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.ORCID http://orcid.org/0000-0001-8826-0453
Marije Van SchalkwykFamily Centre for Research with Ubuntu, Stellenbosch University, Cape Town, South Africa.ORCID http://orcid.org/0000-0003-2679-901X
Benjamin LinasBoston Medical Center, Boston, MA, USA.
Estevao Portela NunesInstituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil 4365 Manguinhos, Rio de Janeiro, RJ, 21040-360, Brazil.ORCID http://orcid.org/0000-0002-0566-8718
Gregory K RobbinsMassachusetts General Hospital, Boston, MA, USA.ORCID http://orcid.org/0000-0001-7545-5817
David WylesDenver Health Medical Center, Denver, CO, USA.
Susanna NaggieDuke University School of Medicine, Durham, NC, USA.ORCID http://orcid.org/0000-0001-7721-6975
Mark SulkowskiJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-2145-6352
Sandra Wagner CardosoInstituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil 4365 Manguinhos, Rio de Janeiro, RJ, 21040-360, Brazil.ORCID http://orcid.org/0000-0001-5230-0003
Sunil SolomonJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-3296-1514

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
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
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
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
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
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI106701NIDA NIH HHS K24 DA034621
6 · The paper itself

Abstract

backgroundDirect-acting antivirals (DAA) are highly effective for the management of HCV disease. This study aims to evaluate changes in health-related quality of life (HQoL) among people with HCV who were treated with DAAs using a minimal monitoring (MINMON) approach.

methodsACTG A5360 was a multicenter, international (Brazil, South Africa, Thailand, Uganda, and USA) trial to assess the feasibility and efficacy of MINMON approach in people with HCV. We measured HQoL using EQ-5D-3L at baseline, sustained virological evaluation visit, week 48 and week 72, and described using EQ-5D summary index (ranges:0-1) and visual analog scale (VAS) score (ranges 0-100). We used paired T-tests to evaluate the change in EQ-5D summary and multivariable linear regression for changes in VAS scores.

resultsOverall, 394 individuals were included; most did not have cirrhosis (360; 91%) or problematic alcohol use (278; 71%). We found HQoL improvements for participants from Brazil and Thailand, but not for the USA. Participants reported high rates of pain/discomfort and anxiety/depression, with decreases over time only for Brazil. Factors associated with larger improvements in VAS scores included: cirrhosis at baseline, and non-use or problematic use of other substances (apart from tobacco/marijuana) compared to non-problematic use.

conclusionWe found HQoL improvements among people with HCV following DAA treatment with variability across countries. Our findings reinforce the importance of DAA treatment, especially among those with advanced HCV disease. Continuous mental health care including depression and substance use support should be offered to individuals after HCV treatment. TRIAL REGISTRATION NUMBER: NCT03512210 (22-Oct-2018) Direct-acting antivirals are highly effective for the management of hepatitis C disease. Recent studies have shown that hepatitis C treatment with direct-acting antivirals has a positive impact on quality of life. However, no studies have assessed quality of life among individuals starting direct-acting antivirals treatment across multiple countries representing high-, middle- and low-income settings. In this study, we evaluated changes in health-related quality of life among people with hepatitis C who were treated with direct-acting antivirals using a simplified treatment delivery and offering minimal in-person monitoring. We found quality of life improvements among persons with hepatitis C after direct-acting antivirals treatment, with differences across countries. Although direct-acting antivirals treatment works well and should be available to all persons with hepatitis C, we found that participants with cirrhosis (liver damage) had higher improvements in quality of life, reinforcing the importance of starting treatment among people with advanced hepatitis C. We also found high rates of anxiety and depression, pointing to the importance of adding mental health care and support to infectious diseases services.

Indexed as

Antiviral AgentsHepatitis CHepatitis C, ChronicQuality of LifeAdultBrazilFemaleHumansMaleMiddle AgedSouth AfricaThailandUgandaUnited StatesAntiviral AgentsCirrhosisDirect-acting antiviralsHealth-related quality of lifeHepatitis CHIVMental health

Identifiers

PMID40019678
PMCPMC12413691

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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.