Evidence map›Paper›PMID 30717681›Full record

Trial reportBMC nephrology2019

A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients.

Michael Duerr, Eva V Schrezenmeier, Lukas J Lehner, Léon Bergfeld, Petra Glander, Stephan R Marticorena Garcia, Christian E Althoff, Ingolf Sack, Susanne Brakemeier, Kai-Uwe Eckardt and 2 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 28% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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  5. Review
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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 1 institution in 1 country.

Michael DuerrDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany. michael.duerr@charite.de.ORCID 0000-0003-1432-421X
Eva V SchrezenmeierDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Lukas J LehnerDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Léon BergfeldDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Petra GlanderDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Stephan R Marticorena GarciaDepartment of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Christian E AlthoffDepartment of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Ingolf SackDepartment of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Susanne BrakemeierDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Kai-Uwe EckardtDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Klemens BuddeDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Fabian HalleckDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Augustenburger Platz, 13353, Berlin, Germany.
Charité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnly a few prospective trials exist regarding the use of novel direct-acting antiviral agents (DAAs) in kidney transplant recipients (KTR) with chronic hepatitis C virus (HCV) infection.

methodsThis prospective single-center trial evaluated treatment with daclatasvir (DCV) and sofosbuvir (SOF) over 12 weeks in 16 adult chronic HCV infected KTR and eGFR > 30 ml/min/1.73m

resultsFour of 16 study patients had previously failed interferon-based HCV treatment. Liver biopsy showed mostly moderate fibrosis score before therapy with DCV/SOF was initiated at a median of 10.3 years after transplantation. In total, 15 of 16 KTR achieved SVR12. One patient showed early viral relapse because of resistance-associated variants (RAVs) in the HCV NS5A region. Rescue treatment with SOF/velpatasvir/voxilaprevir resulted in SVR12. DAAs treatment led to significant improvement of liver metabolism and glucose tolerance accompanied with no therapy-associated major adverse events and excellent tolerability.

conclusionsOur study demonstrates safety, efficacy and functional benefit of DCV/SOF treatment in KTR with chronic HCV infection. We provide data on rescue strategies for treatment failures due to present RAVs and amelioration of hepatic function and glucose tolerance.

trial registrationRegistry name: European Clinical Trials Register; Trial registry number (Eudra-CT): 2014-004551-32 , Registration date: Aug 28th 2015.

Indexed as

Kidney TransplantationAdultAgedAminoisobutyric AcidsAntiviral AgentsBenzimidazolesBenzopyransBiopsy, NeedleCalcineurin InhibitorsCarbamatesCyclopropanesDEAD-box RNA HelicasesDrug Therapy, CombinationFemaleGlucose IntoleranceHepacivirusAminoisobutyric AcidsAntiviral AgentsBenzimidazolesBenzopyransCalcineurin InhibitorsCarbamatesCyclopropanesdaclatasvirDEAD-box RNA HelicasesHeterocyclic Compounds, 4 or More RingsImidazolesLactams, MacrocyclicLeucineMacrocyclic CompoundsNS3 protein, hepatitis C virusNS-5 protein, hepatitis C virusNucleoside-TriphosphataseProlinePyrrolidinesQuinoxalinesRNA-Dependent RNA PolymeraseRNA, ViralSerine EndopeptidasesSofosbuvirSulfonamidesValinevelpatasvirViral Nonstructural ProteinsViral ProteasesvoxilaprevirDaclatasvirDirect-acting antiviralsHCV infectionKidney transplantationSofosbuvir

Identifiers

PMID30717681
PMCPMC6360788
OpenAlexW2921098283

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.