Evidence map›Paper›PMID 28610605›Full record

Trial reportBMC infectious diseases2017

Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study.

Evan B Cunningham, Behzad Hajarizadeh, Olav Dalgard, Janaki Amin, Margaret Hellard, Graham R Foster, Philip Bruggmann, Brian Conway, Markus Backmund, Geert Robaeys and 14 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01364090 (A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 27% 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.

NCT01364090 phase4completednot on this map

A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection Drug Use

TypeinterventionalSponsorKirby InstituteRan2012 to 2015Enrolled93ConditionsHepatitis C, ChronicArmsPegylated interferon alfa 2b, Ribavirin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. 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

24 authors at 13 institutions in 8 countries.

Evan B CunninghamThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia. ecunningham@Kirby.Unsw.Edu.Au.ORCID 0000-0002-8048-3473
Behzad HajarizadehThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Olav DalgardAkershus University Hospital, Oslo, Norway.
Janaki AminThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Margaret HellardBurnet Institute, Melbourne, VIC, Australia.
Graham R FosterThe Liver Unit, Queen Mary University of London, London, UK.
Philip BruggmannArud Centres for Addiction Medicine, Zurich, Switzerland.
Brian ConwayVancouver Infectious Diseases Center, Vancouver, BC, Canada.
Markus BackmundLudwig Maximilians-University Munich, Munich, Germany.
Geert RobaeysDepartment of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Belgium.
Tracy SwanTreatment Action Group, New York, NY, USA.
Philippa S MarksThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Sophie QuieneThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Tanya L ApplegateThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Martin WeltmanNepean Hospital, Sydney, NSW, Australia.
David ShawRoyal Adelaide Hospital, Adelaide, South Australia, Australia.
Adrian DunlopSchool of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.
Julie BruneauResearch Center, Centre Hospitalier de l'Universite de Montreal (CRCHUM), Montreal, Quebec, Canada.
Håvard MidgardAkershus University Hospital, Oslo, Norway.
Stefan BourgeoisStuivenberg ZNA, Antwerp, Belgium.
Maria Christine ThurnheerDepartment of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.
Gregory J DoreThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Jason GrebelyThe Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
ACTIVATE Study Group
UNSW Sydney · AUAkershus University Hospital · NOBurnet Institute · AURoyal Adelaide Hospital · AUUniversity of Bern · CHAddiction Switzerland · CHCentre Hospitalier de l’Université de Montréal · CANepean Hospital · AUQueen Mary University of London · GBTreatment Action Group · USUniversitair Ziekenhuis Leuven · BEVancouver Infectious Diseases Centre · CAZiekenhuis Oost-Limburg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aims of this analysis were to investigate treatment completion and adherence among people with ongoing injecting drug use or receiving opioid substitution therapy (OST) in a study of response-guided therapy for chronic HCV genotypes 2/3 infection.

methodsACTIVATE was a multicenter clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b (PEG-IFN) and self-administered ribavirin for 12 (undetectable HCV RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Outcomes included treatment completion, PEG-IFN adherence, ribavirin adherence, and sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment).

resultsAmong 93 people treated, 59% had recently injected drugs (past month), 77% were receiving OST and 56% injected drugs during therapy. Overall, 76% completed treatment. Mean on-treatment adherence to PEG-IFN and ribavirin were 98.2% and 94.6%. Overall, 6% of participants missed >1 dose of PEG-IFN and 31% took <95% of their prescribed ribavirin., Higher treatment completion was observed among those receiving 12 vs. 24 weeks of treatment (97% vs. 46%, P < 0.001) while the proportion of participants with 95% on-treatment ribavirin adherence was similar between groups (67% vs. 72%, P = 0.664). Receiving 12 weeks of therapy was independently associated with treatment completion. No factors were associated with 95% RBV adherence. Neither recent injecting drug use at baseline nor during therapy was associated with treatment completion or adherence to ribavirin. In adjusted analysis, treatment completion was associated with SVR (aOR 23.9, 95% CI 2.9-193.8).

conclusionsThis study demonstrated a high adherence to directly observed PEG-IFN and self-administered ribavirin among people with ongoing injecting drug use or receiving OST. These data also suggest that shortening therapy from 24 to 12 weeks can lead to improved treatment completion. Treatment completion was associated with improved response to therapy. ACTIVATE trial registration number: NCT01364090 - May 31, 2011.

Indexed as

AdultAntiviral AgentsDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis CHumansInterferon-alphaInterferon alpha-2MaleMiddle AgedOpiate Substitution TreatmentPatient CompliancePolyethylene GlycolsRecombinant ProteinsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsRibavirinAdherenceHepatitis CInjection drug usePWIDTreatment

Identifiers

PMID28610605
PMCPMC5470219
OpenAlexW2624798462

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.