Evidence map›Paper›PMID 29345798›Full record

ArticleBritish journal of clinical pharmacology2018

Clinical impact of pharmacokinetic interactions between the HCV protease inhibitor simeprevir and frequently used concomitant medications.

Fiona Marra, Christoph Höner Zu Siederdissen, Saye Khoo, David Back, Michael Schlag, Sivi Ouwerkerk-Mahadevan, Ceyhun Bicer, Isabelle Lonjon-Domanec, Wolfgang Jessner, Maria Beumont-Mauviel and 2 more

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 43% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Observational
  2. 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 6 institutions in 5 countries.

Fiona MarraDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Crown Street, Liverpool, L69 3BX, UK.
Christoph Höner Zu SiederdissenDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Saye KhooDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Crown Street, Liverpool, L69 3BX, UK.
David BackDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Crown Street, Liverpool, L69 3BX, UK.
Michael SchlagJanssen Cilag Pharma GmbH, EMEA Medical Affairs, Vorgartenstraße 206B, 1020, Vienna, Austria.
Sivi Ouwerkerk-MahadevanJanssen Pharmaceutica, Turnhoutseweg 30, 2340, Beerse, Belgium.
Ceyhun BicerBICER Consulting & Research, Oosterveldlaan 12 A, 2610, Antwerp, Belgium.
Isabelle Lonjon-DomanecJanssen-Cilag, 1 Rue Camille Desmoulins, 92130, Issy-les-Moulineaux, France.
Wolfgang JessnerJanssen Pharmaceutica, Turnhoutseweg 30, 2340, Beerse, Belgium.
Maria Beumont-MauvielJanssen-Cilag, 1 Rue Camille Desmoulins, 92130, Issy-les-Moulineaux, France.
Ronald KalmeijerJanssen Global Services LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Markus CornbergDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
University of Liverpool · GBJanssen (Belgium) · BEJanssen (France) · FRMedizinische Hochschule Hannover · DEJanssen (United States) · USProvince of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsDirect-acting antiviral agents (DAAs) for the treatment of hepatitis C (HCV) can be associated with drug-drug interactions (DDIs) with concomitant medications. The practical clinical implications of such DDIs are poorly understood. We assessed the clinical impact of possible pharmacokinetic (PK) interactions between simeprevir and frequently prescribed concomitant medications.

methodsThis post hoc analysis pooled data from nine studies which evaluated simeprevir (SMV)-based interferon-free HCV treatment. Three classes of frequently used concomitant medications of interest (CMOIs) were analysed [antihypertensive drugs (AHDs), anxiolytic drugs (AXDs) and lipid-lowering drugs (LLDs)] and categorized as amber or green according to their DDI potential with SMV (green: no DDIs; amber: potential/known PK interactions). Concomitant medications not recommended to be coadministered with SMV were not included. The composite primary endpoint was defined as the frequency of either discontinuation, interruption or dose modification of the CMOI during 12 weeks of SMV treatment.

resultsFew patients met the composite endpoint in the various subgroups. Patients on amber CMOIs tended to experience CMOI modification more often (13.4-19.4%) than those on green CMOIs (3.1-10.8%). There was no difference in the frequency of adverse events between patients taking green and those taking amber CMOIs.

conclusionsIn this large pooled analysis, coadministration of the evaluated commonly prescribed medications with known or potential PK interactions with SMV was manageable and resulted in few adjustments of concomitant medications. Our method could serve as a blueprint for the evaluation of the impact of DDIs.

Indexed as

Drug InteractionsAnti-Anxiety AgentsAnticholesteremic AgentsAntihypertensive AgentsClinical Trials as TopicDrug Therapy, CombinationFemaleHumansMaleMeta-Analysis as TopicProtease InhibitorsSimeprevirAnti-Anxiety AgentsAnticholesteremic AgentsAntihypertensive AgentsProtease InhibitorsSimeprevirDDIdrug-drug interactionHCVhepatitis C virussimeprevirSMV

Identifiers

PMID29345798
PMCPMC5903235
OpenAlexW2790788930

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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.