Evidence map›Paper›PMID 26691547›Full record

Trial reportAIDS (London, England)2016

Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir.

Kerry Townsend, Tess Petersen, Lori A Gordon, Anita Kohli, Amy Nelson, Cassie Seamon, Chloe Gross, Lydia Tang, Anu Osinusi, Michael A Polis and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase II
In one paragraph

Trial report in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

NCT01805882 phase2completednot on this map

A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013 to 2015Enrolled229ConditionsHepatitis C, ChronicArmsSofosbuvir, Ledipasvir, GS-9669, GS-9451
NCT01878799 phase2completednot on this map

An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected With HIV

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013 to 2014Enrolled50ConditionsHepatitis C, HIVArmsGS-7977/GS- 5885 FDC
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Trial
  2. Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  3. Article
  4. Article
  5. Article
  6. 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
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Predictive factors of hepatitis C virus eradication after interferon-free therapy in HIV coinfection.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019
    Observational
  12. Review
  13. Article
  14. Review
  15. 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

12 authors.

Kerry TownsendaLaboratory of ImmunoregulationbCritical Care Medicine Department, National Institutes of Health Clinical CentercClinical Center Pharmacy Department, National Institutes of Health, Bethesda, MarylanddCollege of Pharmacy, Xavier University of Louisiana, New Orleans, LouisianaeClinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc), Frederick National Laboratory for Cancer Research, Frederick, MarylandfDivision of Hepatology, St. Josephs Hospital and Medical Center, Creighton University Medical School, Phoenix, ArizonagDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MarylandhGilead Sciences Inc., Foster City, California, USA.
Tess Petersen
Lori A Gordon
Anita Kohli
Amy Nelson
Cassie Seamon
Chloe Gross
Lydia Tang
Anu Osinusi
Michael A Polis
Henry Masur
Shyam Kottilil

Funding

DC Partnership for HIV/AIDS Progress (DC PFAP)ZIACL009010 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2010 to 2025
$0k
CCR NIH HHS HHSN261200800001CIntramural NIH HHS ZIA CL009010NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

objectiveAs the treatment of hepatitis C virus (HCV) infection has evolved to directly acting antiviral agents, the impact of these directly acting antiviral-only regimens on improving adherence to HCV treatment in HIV/HCV coinfected populations has not been evaluated. The study compared adherence to ledipasvir/sofosbuvir (LDV/SOF) in HCV monoinfected and HIV/HCV coinfected individuals.

designAdherence was measured from participants in two phase 2 open-label studies (NCT01805882 and NCT01878799).

methodsHCV treatment-naive, genotype 1 study individuals [HCV monoinfected participants (N = 20) and HIV/HCV coinfected participants, antiretroviral untreated (N = 13) or on combination antiretroviral therapy (N = 37)] were treated with LDV (90 mg) and SOF (400 mg) administered as one tablet once daily for 12 weeks. Adherence was measured using three tools: medication event monitoring system cap, pill count, and patient report.

resultsParticipants were predominately African American (83%) and male (73%), with a median age of 59 years. Participants had prompt HCV viral load decline and high adherence rates (97 ± 0.5% by medication event monitoring system). Participant adherence decreased significantly from early (baseline week 4) as compared with late (weeks 8-12) in therapy in all three groups - HCV monoinfected (P = 0.01), HIV/HCV antiretroviral untreated (P = 0.02), and HIV/HCV antiretroviral treated participants (P = 0.01).

conclusionAdherence to LDV/SOF in this urban population was high and comparable between HCV monoinfected and HIV/HCV coinfected participants regardless of antiretroviral use.

Indexed as

Medication AdherenceAntiviral AgentsBenzimidazolesCoinfectionFemaleFluorenesHepatitis C, ChronicHIV InfectionsHumansMaleMiddle AgedSofosbuvirUrban PopulationAntiviral AgentsBenzimidazolesFluorenesledipasvirSofosbuvir

Identifiers

PMID26691547
PMCPMC10624323

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.