Evidence map›Paper›PMID 28245248›Full record

ArticlePloS one2017

Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study.

Loreta A Kondili, Giovanni Battista Gaeta, Donatella Ieluzzi, Anna Linda Zignego, Monica Monti, Andrea Gori, Alessandro Soria, Giovanni Raimondo, Roberto Filomia, Alfredo Di Leo and 17 more

Erratum issuedOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.9field-weighted citation impact, top 4% 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

18 citing papers in PubMed, 45 citations in OpenAlex.

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  13. [Consensus on management of drug-drug interaction with direct-acting antiviral agents in chronic hepatitis C].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2018
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 14 institutions in 1 country.

Loreta A KondiliDepartment of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Rome, Italy.
Giovanni Battista GaetaInfectious Diseases, Second University of Naples, Naples, Italy.
Donatella IeluzziClinical Unit of Gastroenterology, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
Anna Linda ZignegoCenter for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Monica MontiCenter for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Andrea GoriDepartment of Infectious Diseases, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.
Alessandro SoriaDepartment of Infectious Diseases, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.
Giovanni RaimondoDepartment of Internal Medicine, University Hospital of Messina, Messina Italy.
Roberto FilomiaDepartment of Internal Medicine, University Hospital of Messina, Messina Italy.
Alfredo Di LeoSection of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Andrea IannoneSection of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Marco MassariInfectious Diseases, Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy.
Romina CorsiniInfectious Diseases, Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy.
Roberto GulminettiInfectious Diseases, University of Pavia, Pavia, Italy.
Alberto Gatti CominiInfectious Diseases, University of Pavia, Pavia, Italy.
Pierluigi ToniuttoGastroenterology, Department of Surgical and Gastroenterological Sciences, University of Udine, Udine, Italy.
Denis DissegnaGastroenterology, Department of Surgical and Gastroenterological Sciences, University of Udine, Udine, Italy.
Francesco Paolo RussoDepartment of Surgical and Gastroenterological Sciences, University Hospital of Padua, Padua, Italy.
Alberto ZanettoDepartment of Surgical and Gastroenterological Sciences, University Hospital of Padua, Padua, Italy.
Maria Grazia RumiDivision of Hepatology, Ospedale San Giuseppe, Università degli Studi di Milano, Milan, Italy.
Giuseppina BrancaccioInfectious Diseases, Second University of Naples, Naples, Italy.
Elena DanieliDivision of Infectious Diseases, Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy.
Maurizia Rossana BrunettoHepatology Unit, University Hospital of Pisa, Pisa, Italy.
Liliana Elena WeimerDepartment of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Rome, Italy.
Maria Giovanna QuarantaDepartment of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Rome, Italy.
Stefano VellaDepartment of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Rome, Italy.
Massimo PuotiDivision of Infectious Diseases, Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy.
Istituto Superiore di Sanità · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITSanta Maria Nuova Hospital · ITUniversity of Bari Aldo Moro · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Florence · ITUniversity of Messina · ITUniversity of Milano-Bicocca · ITUniversity of Padua · ITUniversity of Pavia · ITUniversity of Udine · ITAzienda Ospedaliera Universitaria Integrata Verona · ITAzienda Ospedaliera Universitaria Pisana · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are few real-life data on the potential drug-drug interactions (DDIs) between anti-HCV direct-acting antivirals (DAAs) and the comedications used.

aimTo assess the potential DDIs of DAAs in HCV-infected outpatients, according to the severity of liver disease and comedication used in a prospective multicentric study.

methodsData from patients in 15 clinical centers who had started a DAA regimen and were receiving comedications during March 2015 to March 2016 were prospectively evaluated. The DDIs for each regimen and comedication were assigned according to HepC Drug Interactions (www.hep-druginteractions.org).

resultsOf the 449 patients evaluated, 86 had mild liver disease and 363 had moderate-to-severe disease. The use of a single comedication was more frequent among patients with mild liver disease (p = 0.03), whereas utilization of more than three drugs among those with moderate-to-severe disease (p = 0.05). Of the 142 comedications used in 86 patients with mild disease, 27 (20%) may require dose adjustment/closer monitoring, none was contraindicated. Of the 322 comedications used in 363 patients with moderate-to-severe liver disease, 82 (25%) were classified with potential DDIs that required only monitoring and dose adjustments; 10 (3%) were contraindicated in severe liver disease. In patients with mild liver disease 30% (26/86) used at least one drug with a potential DDI whereas of the 363 patients with moderate-to-severe liver disease, 161 (44%) were at risk for one or more DDI.

conclusionsBased on these results, we can estimate that 30-44% of patients undergoing DAA and taking comedications are at risk of a clinically significant DDI. This data indicates the need for increased awareness of potential DDI during DAA therapy, especially in patients with moderate-to-severe liver disease. For several drugs, the recommendation related to the DDI changes from "dose adjustment/closer monitoring", in mild to moderate liver disease, to "the use is contraindicated" in severe liver disease.

Indexed as

Drug InteractionsAdultAgedAged, 80 and overAntiviral AgentsDrug Administration ScheduleDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansInterferonsItalyLiver CirrhosisMaleMiddle AgedAntiviral AgentsInterferons

Identifiers

PMID28245248
PMCPMC5330484
OpenAlexW2592128079

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.