Evidence map›Paper›PMID 26611779›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Drug-Drug Interactions With Novel All Oral Interferon-Free Antiviral Agents in a Large Real-World Cohort.

Christoph Höner Zu Siederdissen, Benjamin Maasoumy, Fiona Marra, Katja Deterding, Kerstin Port, Michael P Manns, Markus Cornberg, David Back, Heiner Wedemeyer

Registry-linked trialOpen access · bronzeAbstract read
PubMed Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03126370 (Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide), which is not on this map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
7.0field-weighted citation impact, top 2% 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.

NCT03126370 phase4completednot on this mapstarted 2018, after this paper: background citation

Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV.

TypeinterventionalSponsorUniversity of Colorado, DenverRan2018 to 2019Enrolled10ConditionsHepatitis C, HIV CoinfectionArmsTDF with a boosted protease inhibitor, TAF with a boosted protease inhibitor, TAF with a boosted protease inhibitor and LDV/SOF
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 93 citations in OpenAlex.

  1. Trial
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  5. High expression of autophagy-related geneWorld journal of clinical cases · 2023
    Article
  6. Observational
  7. Breakthroughs in hepatitis C research: from discovery to cure.Nature reviews. Gastroenterology & hepatology · 2022
    Review
  8. Review
  9. Article
  10. Nanomedicine based approaches for combating viral infections.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Review
  11. Observational
  12. Review
  13. Article
  14. Article
  15. Article
  16. Analysis of the impact of antimicrobial management and rational use of antibiotics.European journal of hospital pharmacy : science and practice · 2020
    Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Christoph Höner Zu SiederdissenDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
Benjamin MaasoumyDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
Fiona MarraDepartment of Molecular and Clinical Pharmacology, University of Liverpool Pharmacy Department, Gartnavel General Hospital, Glasgow, Scotland, United Kingdom.
Katja DeterdingDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
Kerstin PortDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
Michael P MannsDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
Markus CornbergDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
David BackDepartment of Molecular and Clinical Pharmacology, University of Liverpool.
Heiner WedemeyerDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany.
Medizinische Hochschule Hannover · DEGartnavel General Hospital · GBUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith the approval of direct-acting antivirals (DAAs), the management of drug-drug interactions (DDIs) has become an important challenge while treating individuals with hepatitis C. To date, the potential of causing DDIs for the recently approved DAAs has not been systematically investigated. We aimed to assess the clinical significance of DDI between the regular outpatient medications and DAA therapies in a large real-world cohort.

methodsOverall, 261 hepatitis C virus monoinfected patients who were selected for DAA therapy at 2 intervals between 2011 and 2014 were asked about their regular outpatient medications. The potential for DDIs between all these drugs and sofosbuvir/ribavirin, ledipasvir/sofosbuvir, sofosbuvir/daclatasvir, sofosbuvir/simeprevir, ombitasvir/paritaprevir/ritonavir ± dasabuvir as well as boceprevir and telaprevir triple therapy was assessed using www.hep-druginteractions.org and the relevant prescribing information.

resultsThe 261 patients took a median number of 2 drugs (range 0-15); 20% of patients did not take any medication. Sofosbuvir/ribavirin had the lowest risk to cause a potentially significant DDI (9.6%). In contrast, for ombitasvir/paritaprevir/ritonavir ± dasabuvir potentially significant DDIs could be expected in 66.3% of the patients. Significant DDIs for sofosbuvir/simeprevir would be expected in 31.4%, for sofosbuvir/daclatasvir in 36.8%, and for sofosbuvir/ledipasvir in 40.2%. Proton pump inhibitors, thyroid hormones, and dihydropyridine derivatives were frequently used and presented a risk of interacting with the antiviral regimen.

conclusionsA significant number of patients are at risk for DDIs if treated with the recently approved DAA regimens. A careful evaluation of potential DDI is essential to prevent adverse effects or unnecessary risk of treatment failure.

Indexed as

Antiviral AgentsCohort StudiesDrug InteractionsHepatitis COutpatientsAntiviral Agentsantiviral therapycytochrome P450direct-acting antiviral agentsdrug–drug interactionshepatitis C virus

Identifiers

PMID26611779
OpenAlexW2241552982

What OpenQuestion holds

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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.