Evidence map›Paper›PMID 29378602›Full record

ArticleVirology journal2018

A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection.

Fabien Zoulim, Christophe Moreno, Samuel S Lee, Peter Buggisch, Andrzej Horban, Eric Lawitz, Chris Corbett, Oliver Lenz, Bart Fevery, Thierry Verbinnen and 2 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Virology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01349465 (A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus), 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
–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.

NCT01349465 phase3completednot on this map

A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

TypeinterventionalSponsorJanssen R&D IrelandRan2011 to 2016Enrolled249ConditionsHepatitis CArmsNo treatment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  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.

Fabien ZoulimINSERM U1052-CNRS 5286, Cancer Research Center of Lyon (CRCL) and Hepatology Department, Lyon, France. fabien.zoulim@inserm.fr.ORCID 0000-0002-2245-0083
Christophe MorenoCUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
Samuel S LeeLiver Unit, University of Calgary, Calgary, AB, Canada.
Peter BuggischInstitute for Interdisciplinary Medicine, Hamburg, Germany.
Andrzej HorbanDepartment for Adult's Infectious Diseases, Hospital for Infectious Diseases, HIV Out-Patient Clinic and Medical University of Warsaw, Warsaw, Poland.
Eric LawitzTexas Liver Institute, University of Texas Health, San Antonio, TX, USA.
Chris CorbettJanssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
Oliver LenzJanssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
Bart FeveryJanssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
Thierry VerbinnenJanssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
Umesh ShuklaJanssen Research & Development, LLC, Titusville, NJ, USA.
Wolfgang JessnerJanssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSimeprevir is approved with pegylated interferon and ribavirin (PR) for chronic hepatitis C virus (HCV) genotype (GT) 1 and GT4 infection in the USA and the European Union.

methodsThis 3-year follow-up study assessed the durability of sustained virologic response (SVR) (undetectable HCV RNA 12 or 24 weeks after treatment end), and evaluated the persistence of treatment-emergent NS3/4A protease inhibitor resistance in patients not achieving SVR following treatment with simeprevir plus PR in the parent study. The maintenance of SVR after the last post-therapy follow-up visit of the parent study (LPVPS) was assessed using HCV RNA measurements. The persistence of treatment-emergent NS3 amino acid substitutions in patients with no SVR at LPVPS was assessed using population sequencing. No study medications were administered.

resultsOverall, 249 patients were enrolled (200 with SVR at LPVPS; 49 with no SVR at LPVPS); 40 patients discontinued prematurely (18 with SVR; 22 with no SVR). All 200 enrolled patients who achieved SVR in the parent study maintained SVR until the last available visit in this study (median follow-up time: 35.8 months). The treatment-emergent NS3 amino acid substitutions detected at time of failure in the parent study in 43/49 enrolled patients were no longer detected in 37/43 (86.0%) at the end of this study (median follow-up time: 179.9 weeks [41.3 months]).

conclusionThis 3-year follow-up study provides evidence for the long-term durability of SVR (100%) after successful treatment with simeprevir plus PR. Treatment-emergent NS3 amino acid substitutions became undetectable in the majority of patients.

trial registrationNCT01349465; ClinicalTrials.gov .

Indexed as

AdultAgedAged, 80 and overAntiviral AgentsDrug Resistance, ViralDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusHepatitis C, ChronicHumansInterferon-alphaMaleMiddle AgedMutationAntiviral AgentsInterferon-alphaRibavirinSimeprevirDirect-acting antiviralsHepatitis C virusNS3 amino acid substitutionsPegylated interferonSimeprevirSustained virologic response

Identifiers

PMID29378602
PMCPMC5789677

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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.