Evidence map›Paper›PMID 26612014›Full record

Trial reportHepatology international2016

High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study.

Tess Petersen, Kerry Townsend, Lori A Gordon, Sreetha Sidharthan, Rachel Silk, Amy Nelson, Chloe Gross, Monica Calderón, Michael Proschan, Anu Osinusi and 4 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hepatology international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% 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

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

  1. Pooled it
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  17. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Article
  18. Observational
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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

14 authors at 6 institutions in 1 country.

Tess PetersenCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Kerry TownsendLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Lori A GordonClinical Center Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.
Sreetha SidharthanCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Rachel SilkCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Amy NelsonDivision of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
Chloe GrossDivision of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
Monica CalderónClinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Michael ProschanBiostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.
Anu OsinusiLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Michael A PolisLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Henry MasurCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Shyam KottililLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. SKottilil@ihv.umaryland.edu.
Anita KohliCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
National Institutes of Health Clinical Center · USUniversity of Maryland, Baltimore · USNational Institutes of Health · USFrederick National Laboratory for Cancer Research · USLeidos (United States) · USSt. Joseph's Hospital and Medical Center · US

Funding

Xavier's RCMI Cancer Research ProgramG12MD007595 · NIMHD · XAVIER UNIVERSITY OF LOUISIANA · PI D'AMOUR, GENE, WANG, GUANGDI · 2012 to 2018
$15.7M
DC Partnership for HIV/AIDS Progress (DC PFAP)ZIACL009010 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2010 to 2025
$0k
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001ENIMHD NIH HHS G12 MD007595
6 · The paper itself

Abstract

backgroundAs treatment for chronic hepatitis C (HCV) virus has evolved to all-oral, interferon-free directly acting antiviral (DAA) therapy, the impact of these improvements on patient adherence has not been described.

methodsMedication adherence was measured in 60 HCV, genotype-1, treatment-naïve participants enrolled in a phase 2a clinical trial at the National Institutes of Health and community clinics. Participants received either ledipasvir/sofosbuvir (LDV/SOF) (90 mg/400 mg) (one pill) daily for 12 weeks, LDV/SOF + GS-9451 (80 mg/day) (two pills) daily for 6 weeks, or LDV/SOF + GS-9669 (500 mg twice daily; three pills, two in the morning, one in the evening) for 6 weeks. Adherence was measured using medication event monitoring system (MEMS) caps, pill counts and patient report.

resultsOverall adherence to DAAs was high. Adherence declined over the course of the 12-week treatment (p = 0.04). While controlled psychiatric disease or symptoms of depression did not influence adherence, recent drug use was a risk factor for non-adherence to 12-week (p = 0.01), but not 6-week regimens. Adherence as measured by MEMS was lower than by patient report.

conclusionsAdherence to short courses of DAA therapy with 1-3 pills a day was excellent in an urban population with multiple risk factors for non-adherence.

Indexed as

Medication AdherenceAdministration, OralAntiviral AgentsDrug Administration ScheduleDrug Therapy, CombinationFemaleHepatitis C, ChronicHumansMaleMiddle AgedTreatment OutcomeUrban PopulationAntiviral AgentsAdherenceDAAHCVMEMS

Identifiers

PMID26612014
PMCPMC4778154
OpenAlexW2288196111

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.