Evidence map›Paper›PMID 28477061›Full record

ArticleInfectious diseases and therapy2017

Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study.

Geert Robaeys, Stefan Christensen, Damien Lucidarme, Amber Arain, Philip Bruggmann, Jan Kunkel, Sofia Keim, Martin Jäkel, Ralph DeMasi, Chris Liu and 2 more

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

Article in Infectious diseases and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01980290 (Observational Multicenter Study in Ex-People Who INject Drugs), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT01980290 completednot on this map

Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts

TypeobservationalSponsorJanssen Pharmaceutica N.V., BelgiumRan2013 to 2015Enrolled50ConditionsHepatitis, Chronic
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Hepatitis C Treatment in Patients with Drug Addiction Is Effective or Not Effective?Medical archives (Sarajevo, Bosnia and Herzegovina) · 2018
    Article
  3. 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 at 7 institutions in 6 countries.

Geert RobaeysFaculty of Medicine and Life Sciences, University Hasselt Campus Diepenbeek, Diepenbeek, Belgium. Geert.Robaeys@ZOL.BE.
Stefan ChristensenInfectious Diseases, Center for Interdisciplinary Medicine (CIM), Münster, Germany.
Damien LucidarmeUniversite Nord de France, 59000, Lille, France.
Amber ArainFaculty of Medicine and Life Sciences, University Hasselt Campus Diepenbeek, Diepenbeek, Belgium.
Philip BruggmannArud Centres for Addiction Medicine, Zurich, Switzerland.
Jan KunkelHepatology Unit, Queen Mary University of London, London, UK.
Sofia KeimJanssen-Cilag, Barcarena, Portugal.
Martin JäkelJanssen-Cilag B.V, Breda, The Netherlands.
Ralph DeMasiJanssen Research and Development LLC, Titusville, USA.
Chris LiuJanssen Research and Development LLC, Titusville, USA.
Isabelle Lonjon-DomanecJanssen-Cilag, Paris, France.
Graham R FosterHepatology Unit, Queen Mary University of London, London, UK.
Janssen (United States) · USQueen Mary University of London · GBZiekenhuis Oost-Limburg · BEAddiction Switzerland · CHHôpital Saint-Philibert · FRJanssen (France) · FRJanssen (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPeople who inject drugs represent an under-treated chronic hepatitis C virus (HCV)-infected patient population.

methodsINTEGRATE was a prospective, observational study investigating the effectiveness, safety, and adherence in routine clinical practice to telaprevir in combination with peg-interferon and ribavirin (Peg-IFN/RBV) in patients with history of injecting drug use chronically infected with genotype 1 HCV.

resultsA total of 46 patients were enrolled and included in the intent-to-treat (ITT) population. Among heroin and/or cocaine users (n = 37; 80%), 22% reported use in the past month; 74% (34/46) of patients were on opioid substitution therapy in the pre-treatment phase, and 43% (20/46) discontinued HCV treatment prematurely. Sustained virologic response rate was 54% (25/46) in the ITT population and 74% (25/34) in the per protocol (evaluable-for-effectiveness) population. The main reason for failure in the ITT analysis was loss to follow-up (n = 8; 17%). Adverse events occurred in 91% (42/46) of patients. Mean patient-reported adherence to study drugs was >89% at Week 4, Week 12 and end of treatment.

conclusionDespite a high rate of treatment discontinuation (including loss to follow-up), self-reported adherence to treatment was good and virologic cure rates were similar to those reported in large real-world cohorts. Our findings suggest that people with a history of injecting drug use should be considered for treatment of chronic HCV infection, and highlight the need for improvements in patient support to boost retention in care and, in turn, help to prevent reinfection and transmission. CLINICAL

trial registrationClinicaltrials.gov identifier, NCT01980290.

fundingJanssen Pharmaceuticals.

Indexed as

HCVInjection drug usersOpioid substitution therapyPWIDRetention in careTelaprevir

Identifiers

PMID28477061
PMCPMC5446371
OpenAlexW2610560970

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.