Evidence map›Paper›PMID 36694361›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment.

Leonard A Sowah, Laura Smeaton, Irena Brates, Debika Bhattacharya, Benjamin Linas, Bruce Kreter, Sandra Wagner-Cardoso, Sunil Solomon, Mark Sulkowski, Gregory K Robbins

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

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

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    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

10 authors at 6 institutions in 1 country.

Leonard A SowahTherapeutic Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.ORCID 0000-0002-4389-1013
Laura SmeatonDepartment of Biostatistics, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.
Irena BratesDepartment of Biostatistics, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.
Debika BhattacharyaDavid Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, USA.
Benjamin LinasBoston University School of Medicine, Boston, Massachusetts, USA.
Bruce KreterGilead Sciences Inc, Foster City, California, USA.
Sandra Wagner-CardosoInstituto Nacional de Infectologia-Laboratorio de Pesquisa Clínica em HIV/AIDS, Rio de Janeiro, Brazil.
Sunil SolomonJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mark SulkowskiJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Gregory K RobbinsMassachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Harvard University · USJohns Hopkins University · USBoston University · USGilead Sciences (United States) · USNational Institute of Allergy and Infectious Diseases · USUniversity of California, Los Angeles · 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
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
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
UCLA AIDS Prevention and Treatment Clinical Trials UnitU01AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 2007 to 2011
$13.9M
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 TR001873NCATS NIH HHS UL1 TR002384NIAID NIH HHS U01 AI069424NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI106701NIDA NIH HHS K24 DA034621NIH HHS UM1 AI068634
6 · The paper itself

Abstract

backgroundWith the advent of efficacious oral direct-acting antivirals (DAAs) for hepatitis C virus (HCV), identification of characteristics associated with adherence is critical to treatment success. We examined correlates of sub-optimal adherence to HCV therapy in a single-arm, multinational, clinical trial.

methodsACTG A5360 enrolled HCV treatment-naive persons without decompensated cirrhosis from 5 countries. All participants received a 12-weeks course of sofosbuvir/velpatasvir at entry. In-person visits occurred at initiation and week 24, sustained virologic response (SVR) assessment. Adherence at week 4 was collected remotely and was dichotomized optimal (100%, no missed doses) versus sub-optimal (<100%). Correlates of sub-optimal adherence were explored using logistic regression.

resultsIn total, 400 participants enrolled; 399 initiated treatment; 395/397 (99%) reported completing at week 24. Median age was 47 years with 35% female. Among the 368 reporting optimal adherence at week 4 SVR was 96.5% (95% confidence interval [CI] [94.1%, 97.9%]) vs 77.8% (95% CI [59.2%, 89.4%]) P value < .001. In the multivariate model age <30 years and being a US participant were independently associated with early sub-optimal adherence. Participants <30 years were 7.1 times more likely to have early sub-optimal adherence compared to their older counterparts.

conclusionsSelf-reported optimal adherence at week 4 was associated with SVR. Early self-reported adherence could be used to identify those at higher risk of treatment failure and may benefit from additional support. Younger individuals <30 years may also be prioritized for additional adherence support. Clinical Trials Registration. NCT03512210.

Indexed as

Hepatitis CHepatitis C, ChronicAdultAntiviral AgentsBenzimidazolesBenzopyransCarbamatesFemaleGenotypeHepacivirusHeterocyclic Compounds, 4 or More RingsHumansMaleMiddle AgedSofosbuvirSustained Virologic ResponseAntiviral AgentsBenzimidazolesBenzopyransCarbamatesHeterocyclic Compounds, 4 or More RingsSofosbuvirvelpatasviradherencehealth system capacityhepatitis Cminimum monitoringremote patient contact

Identifiers

PMID36694361
PMCPMC10249990
OpenAlexW4317888716

What OpenQuestion holds

Textmetadata
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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.